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A Study of Single and Multiple Ascending Doses of H021 in Healthy Participants

PHASE1UNKNOWN

The primary purpose of this study is to evaluate the safety and tolerability of H021 tablets following oral administration of single and multiple ascending doses in healthy participants.

Study details:

This is a single center, Phase 1, randomized, double-blind, placebo controlled, sequential single ascending dose/multiple ascending dose (SAD/MAD) study, with a food-effect arm. The study will be divided into two parts:. * SAD cohorts, with food-effect evaluation.

* MAD cohorts The two parts will be completed sequentially but with partial overlapping. The MAD phase can start once safety, tolerability, and pharmacokinetic data from the SAD phase show that single doses of at least 25 mg are acceptable. If the 25 mg dose will be not reached in the SAD phase, the Safety Review Committee (SRC) will set a new starting dose.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), greater than and equal to (>=) 18 and less than and equal to (<=) 55 years of age, with body mass index (BMI) greater than (>)18.5 and less than (<) 32.0 kilograms per square meter (kg/m^2).
  2. Healthy as defined by: 1. the absence of clinically significant illness and surgery within 4 weeks prior to study drug administration. 2. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
  3. Female participants of non-childbearing potential must be: 1. post-menopausal (spontaneous amenorrhea for at least 12 months prior to dosing) with confirmation by documented follicle-stimulating hormone (FSH) levels >=40 milli-international units per milliliter (mIU/mL); or 2. surgically sterile (bilateral oophorectomy, bilateral salpingectomy, hysterectomy, or bilateral tubal occlusion) at least 3 months prior to dosing.
  4. Participants must be willing not to donate sperm for 90 days or ova (egg) for 6 months after the last dose.
  5. Sexually active females of childbearing potential and non-sterile males must be willing to use an acceptable contraceptive method throughout the study.
  6. Able to understand the study procedures and provide signed informed consent to participate in the study.

Exclusion criteria

  1. Any clinically significant abnormal finding at physical examination.
  2. Clinically significant abnormal laboratory test results including biochemistry, hematology, urinalysis, and coagulation results, or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody, or QuantiFERON®-TB test at screening.
  3. Positive pregnancy test or lactating female participant.
  4. Positive urine drug screen, urine cotinine test, or alcohol breath test at screening or Day -1.
  5. History of significant allergic reactions (example, anaphylactic reaction, hypersensitivity, angioedema) to any drug.
  6. Clinically significant ECG abnormalities or vital signs abnormalities (systolic blood pressure lower than 90 or over 140 millimetres of mercury (mmHg), diastolic blood pressure lower than 40 or over 90 mmHg, heart rate less than 40 or over 100 beats per minute (bpm), respiratory rate less than 10 or over 22 bpm), or oxygen saturation less than 95 percent (%) oxygen at screening.
  7. History of drug abuse within 1 year prior to screening as determined by the investigator.
  8. History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 1 month prior to screening that exceeds 10 units of alcohol per week for women and men (1 unit = 375 [milliliter] mL of beer 3.5%, 100 mL of wine 13.5%, or 30 mL of distilled alcohol 40%).
  9. History of active tuberculosis or presence of active or latent tuberculosis. Previous latent tuberculosis that has been treated and is no longer active is not exclusionary.
  10. History of clinically significant opportunistic infection (example, invasive candidiasis or pneumocystis pneumonia).
  11. History of serious local infection (example, cellulitis, abscess) or systemic infection (example, septicemia) within 3 months prior to screening.
  12. Presence of fever (body temperature greater than (>) 37.5 degrees Celsius (°C) (example, a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to dosing.
  13. Use of medications within the timeframes specified.
  14. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or simultaneous participation in an investigational study involving no drug or device administration.
  15. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.
  16. Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE1

trial

Study ID

NCT06627556

Intervention or treatment

DRUG: H021

DRUG: H021 Placebo

Conditions

  • Ulcerative Colitis

  • Condition: Ulcerative Colitis

  • DRUG: H021 and other drugs

  • Melbourne, Victoria, Australia

  • Sponsor: Jiangsu Carephar Pharmaceutical Co., Ltd.

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Nucleus Network Ply Ltd.

Select from list below to view details:

  • Nucleus Network Ply Ltd.

    Melbourne, Victoria, Australia

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Who is running the clinical trial?

JCPCL

Jiangsu Carephar Pharmaceutical Co., Ltd.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: SAD Cohort 1: H021 6.25 milligrams (mg)
  • Participants will receive H021, 6.25 mg oral tablet, as single-dose on Day 1 under fasting or fed conditions.
Drug: H021
    EXPERIMENTAL: SAD Cohort 2: H021 12.5 mg
    • Participants will receive H021, 12.5 mg oral tablet, as single-dose on Day 1 under fasting conditions.
    Drug: H021
      EXPERIMENTAL: SAD Cohort 3: H021 25 mg
      • Participants will receive H021, 25 mg oral tablet, as single-dose on Day 1 under fasting conditions.
      Drug: H021
        EXPERIMENTAL: SAD Cohort 4: H021 50 mg
        • Participants will receive H021, 50 mg oral tablet, as single-dose on Day 1 under fasting conditions.
        Drug: H021
          EXPERIMENTAL: SAD Cohort 5: H021 100 mg
          • Participants will receive H021, 100 mg oral tablet, as single-dose on Day 1 under fasting conditions.
          Drug: H021
            EXPERIMENTAL: MAD Cohort 6: H021 12.5 mg
            • Participants will receive H021, 12.5 mg oral tablet once daily from Day 1 to Day 7 under fasting conditions.
            Drug: H021
              EXPERIMENTAL: MAD Cohort 7: H021 25 mg
              • Participants will receive H021, 25 mg oral tablet once daily from Day 1 to Day 7 under fasting conditions.
              Drug: H021
                EXPERIMENTAL: MAD Cohort 8: H021 50 mg
                • Participants will receive H021, 50 mg oral tablet once daily from Day 1 to Day 7 under fasting conditions.
                Drug: H021
                  PLACEBO_COMPARATOR: SAD-H021 Placebo
                  • Participants will receive H021, placebo oral tablet, as single-dose on Day 1 under fasting or fed conditions.
                  Drug: H021 Placebo
                    PLACEBO_COMPARATOR: MAD-H021 Placebo
                    • Participants will receive H021, placebo oral tablet once daily from Day 1 to Day 7 under fasting conditions.
                    Drug: H021 Placebo

                      What is the study measuring?

                      Primary Outcome

                      MeasureDescriptionTime Frame
                      Number of Participants with Adverse Events (AEs)An AE is defined as any untoward medical occurrence in a participant or clinical trial participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Any clinically significant changes in vital signs, electrocardiogram (ECG) measurement, physical examination and clinical laboratory parameters will be recorded as AE.Up to final follow-up (SAD Part: up to 8 days: MAD Part: up to 14 days)

                      Secondary Outcome

                      MeasureDescriptionTime Frame
                      SAD Part: Area under the concentration-time curve from time zero until the last observed concentration (AUC0-t) of H021AUC0-t is an area under the concentration-time curve from time zero (pre-dose) to time of last observed concentration.pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
                      SAD Part: Area under the concentration-time curve from time zero to infinity (AUC0-infinity) of H021AUC0-infinity is an area under the concentration-time curve from time zero to infinity (extrapolated).pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
                      SAD Part: Maximal observed concentration (Cmax) of H021Cmax is a measure of the maximum amount of drug in the plasma after the dose was given.pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
                      SAD Part: Time to Reach Cmax (Tmax) of H021Tmax is a measure of the time to reach the maximum concentration in the plasma after the dose was given.pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
                      SAD Part: Lag Time (Tlag) of H021Tlag is time of observation prior to the first observation with a measurable (non-zero) concentration (for food effect cohort only).pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
                      SAD Part: Residual area of H021Residual area is calculated as percentage of AUC0-inf due to extrapolation from the time of the last observed concentration to infinity, calculated as \[1 - (AUC0-t/AUC0-inf)\] x 100.pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24), and 48 hours post-dose
                      SAD Part: Terminal elimination half-life (T1/2 el) of H021T1/2 el is defined as the duration until observation of half of the maximum concentration of drug dose.pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
                      SAD Part: Terminal elimination rate constant (Kel) of H021Kel is defined as first-order rate constant associated with the terminal (log-linear) portion of the curve.pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
                      SAD Part: Apparent clearance (CL/F) of H021CL/F is apparent total clearance of the drug from plasma after oral administrationpre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
                      SAD Part: Apparent volume of distribution (Vz/F) of H021Vz/F is apparent volume of distribution during terminal phase after non-intravenous administrationpre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
                      SAD Part: Cumulative Urinary Excretion From Time Zero to Time t (Ae0-t) of H021Ae0-t is defined as cumulative urinary excretion from time zero to time t, calculated as the sum of the amounts excreted over each collection interval.pre-dose (spot; within 2 hours) and 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose
                      SAD Part: Maximal Rate of Urinary Excretion (Rmax) of H021Rmax is defined as maximal rate of urinary excretion, calculated by dividing the amount of drug excreted in each collection interval by the time over which it was collected.pre-dose (spot; within 2 hours) and 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose
                      SAD Part: Time of Maximal Urinary Excretion (TRmax) of H021TRmax is defined as time of maximal urinary excretion, calculated as the midpoint of the collection interval during which Rmax occurred.pre-dose (spot; within 2 hours) and 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose
                      SAD Part: Renal Clearance (CLR) of H021CLR is renal clearance, calculated as Ae0-t /AUC0-t.pre-dose (spot; within 2 hours) and 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose
                      MAD Part: Area under the concentration-time curve from time zero to time 24 hours (AUC0-24) of H021AUC0-24 is an area under the concentration-time curve from time zero to 24 hours post-dose.Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
                      MAD Part: Cmax of H021Cmax is a measure of the maximum amount of drug in the plasma after the dose was given.Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
                      MAD Part: Tmax of H021Tmax is a measure of the time to reach the maximum concentration in the plasma after the dose was given.Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
                      MAD Part: Area under the concentration-time curve for one dosing interval (τ) at steady- state (AUC0-τ) of H021AUC0-τ is an area under the concentration-time curve for one dosing interval (τ) at steady- state. In this study τ = 24 hours (equivalent to AUC0-24) will be reported.Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
                      MAD Part: Cmax ss of H021Cmax ss is a measure of the maximum amount of drug in the plasma at steady-state after the dose was given.Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
                      MAD Part: Tmax ss of H021Tmax ss is a measure of the time to reach the maximum concentration in the plasma at steady state after the dose was given.Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
                      MAD Part: Minimal observed concentration at steady-state (Cmin ss) of H021Cmin ss is minimal observed concentration at steady-state.Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
                      MAD Part: AUC0-t of H021AUC0-t is an area under the concentration-time curve from time zero (pre-dose) to time of last observed concentration.Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
                      MAD Part: AUC0-inf of H021AUC0-infinity is an area under the concentration-time curve from time zero to infinity (extrapolated).Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
                      MAD Part: Residual area of H021Residual area is calculated as percentage of AUC0-inf due to extrapolation from the time of the last observed concentration to infinity, calculated as \[1 - (AUC0-t/AUC0-inf)\] x 100.Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
                      MAD Part: T½ el of H021T1/2 el is defined as the duration until observation of half of the maximum concentration of drug dose.Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
                      MAD Part: Kel of H021Kel is defined as first-order rate constant associated with the terminal (log-linear) portion of the curve.Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
                      MAD Part: Apparent clearance at steady-state (Clss/F) of H021Clss/F is apparent clearance at steady-state.Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
                      MAD Part: Apparent volume of distribution at steady-state (Vz ss/F) of H021Vz ss/F is apparent volume of distribution at steady-state.Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
                      MAD Part: Accumulation ratio (RAUC)RAUC is accumulation ratio for AUC.Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
                      MAD Part: Accumulation Ratio (RCmax)RCmax is accumulation ratio for Cmax.Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
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                      References

                      Clinical Trials Gov: A Study of Single and Multiple Ascending Doses of H021 in Healthy Participants

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