OverviewStudy detailsEligibilityThings to knowResearchStudy plan
info
Simplify with AI

A Study of Orally Administered IPG7236 in Healthy Adult Participants

PHASE1TERMINATED

The study is a phase 1, randomized, double-blind, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetic and food effect of orally administered IPG7236 in healthy adult participants.

Study details:

The study consists of two parts. Part A (Single ascending dose): There are total 8 Single Ascending Dose cohorts. Dose levels are as follows Cohort 1: 25 mg of IPG7236 or placebo as per the randomization code, Cohort 2: 50 mg of IPG7236 or placebo as per the randomization code Cohort 3: 100 mg of IPG7236 or placebo as per the randomization code Cohort 4: 200 mg of IPG7236 or placebo as per the randomization code Cohort 5: 300 mg of IPG7236 or placebo as per the randomization code Cohort 6: 400 mg of IPG7236 or placebo as per the randomization code Cohort 7: 500 mg of IPG7236 or placebo as per the randomization code Cohort 8: 600 mg of IPG7236 or placebo as per the randomization code In Cohort 1 total of 6 subjects enrolled.

The 4 subjects will receive IPG7236 and 2 subjects will receive the placebo as per the randomization code. In Cohort 2 to Cohort 8, 6 subjects will receive IPG7236 and 2 subjects will receive the placebo as per the randomization code. Part B (Multiple ascending dose): There are total 3 Multiple ascending dose cohorts.

Dose levels are as follows Cohort 1: 100 mg of IPG7236 or placebo as per the randomization code Cohort 2: 300 mg of IPG7236 or placebo as per the randomization code Cohort 3: 500 mg of IPG7236 or placebo as per the randomization code Total of 8 subjects per cohort, 6 subjects will receive IPG7236 and 2 subjects will receive placebo per the randomization code The Multiple Ascending Dose phase of Cohort 1, Cohort 2 and Cohort 3 will commence based on the safety and tolerability data obtained from Single Ascending Dose phase of Cohort 4, Cohort 6 and Cohort 8.

Eligibility criteria

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

Inclusion criteria

  1. Healthy adult male or female participants between 18 and 55 years of age (inclusive).
  2. Body weight between 45 and 100 kg (inclusive) and body mass index (BMI) within 18~32 kg/m2 (inclusive).
  3. In good health as determined by screening tests. Good health is defined as having no clinically relevant abnormalities identified by a detailed medical history, full physical examination (including measurement of blood pressure and pulse rate), 12-lead Electrocardiograph (ECG), and clinical laboratory tests.
  4. A negative result on urine drug screen and a repeat negative result on Day -1 (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
  5. Female participants must not be pregnant or breastfeeding and must use an effective contraception method with the exception of participants who have undergone sterilization more than 3 months prior to screening or who are postmenopausal.
  6. Provide written informed consent prior to undertaking any study-related procedures.
  7. Must not be under any administrative or legal supervision or under institutionalization as per a regulatory or juridical order.

Exclusion criteria

  1. Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, musculoskeletal, rheumatological, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
  2. Frequent severe headaches and/or migraines, recurrent nausea and/or vomiting (defined as vomiting more than twice a month).
  3. Made a blood or plasma donation of ≥500 ml within 1 month prior to the first dose.
  4. Demonstrated clinically significant (required intervention, e.g., emergency room visit, epinephrine administration) allergic reactions, which in the opinion of the Investigator, would interfere with the volunteer's ability to participate in the trial.
  5. Known hypersensitivity to any component of the IMP formulation.
  6. History or presence of drug or alcohol abuse (defined as alcohol consumption of more than 2 units per day on a regular basis).
  7. Regular smoking (defined as more than 5 cigarettes or equivalent per week), or unable to stop smoking during the study. Occasional smokers may be enrolled but need to abstain during admission to the site.
  8. Excessive consumption of beverages containing xanthine bases (defined as more than 4 glasses per day).
  9. Any medication, including St John's Wort, within 14 days prior to administration of the first dose or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception, menopausal hormone replacement therapy, or occasional paracetamol at doses up to 2g/day.
  10. Any consumption of grapefruit or products containing grapefruit within 5 days prior to the first dose administration.
  11. Any vaccination in the 2 weeks prior to administration of the first dose (Covid19 vaccination included, and planned COVID19 vaccinations, including booster shots, during the study or for 2 weeks after the last dose of the study drug).
  12. Any participant who, in the judgment of the Investigator, is likely to be non-compliant during the study, or to be unable to cooperate due to language problems or poor mental development.
  13. Any participant who enrolled in or participated in any other clinical study involving an investigational medicinal product, or in any other type of medical research within 1 month or within 5 times the elimination half-life prior to administration of the first dose.
  14. Any participant who cannot be contacted in the case of an emergency.
  15. Any participant who is the Investigator or any subinvestigator, research assistant, pharmacist, study coordinator, or other staff thereof directly involved in conducting the study or any person dependent on (employees or immediate family members) the study site, the Investigator or the Sponsor.
  16. Positive result on any of the following tests: hepatitis B surface antigen (HbsAg), hepatitis B core antibodies (HbcAb), anti-hepatitis C virus antibodies (anti-HCV), anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti-HIV2 Ab).
  17. Positive alcohol test at D-1.
  18. Any participant in whom venous blood collection is difficult.

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

NCT05288543

Intervention or treatment

DRUG: IPG7236- Single ascending dose

DRUG: IPG7236- Multiple ascending dose

OTHER: Placebo (Part A)

Conditions

  • Atopic Dermatitis

  • Condition: Atopic Dermatitis

  • DRUG: IPG7236- Single ascending dose and other drugs

  • Randwick, New South Wales, Australia

  • Sponsor: Nanjing Immunophage Biotech Co., Ltd

Save

Share

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial?

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

Research sites nearby

Closest Location:

Scientia Clinical Research Ltd

Select from list below to view details:

  • Scientia Clinical Research Ltd

    Randwick, New South Wales, Australia

Loading map...

Who is running the clinical trial?

NIBCL

Nanjing Immunophage Biotech 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: Single Ascending Dose Phase
  • Drug: IPG7236 Dosage form: Tablet Route of Administration: Oral Dose level: Cohort 1 (25 mg), Cohort 2 (50 mg), Cohort 3 (100 mg), Cohort 4 (200 mg), Cohort 5 (300 mg), Cohort 6 (400 mg), Cohort 7 (500 mg) and Cohort 8 (600 mg)
Drug: IPG7236- Single ascending dose
    EXPERIMENTAL: Multiple Ascending Dose Phase
    • Drug: IPG7236 Dosage form: Tablet Route of Administration: Oral Dose level: Cohort 1 (100 mg), Cohort 2 (300 mg) and Cohort 3 (500 mg)
    Drug: IPG7236- Multiple ascending dose
      PLACEBO_COMPARATOR: Part A (Placebo)
      • Placebo tablets identical to IPG7236 tablets Dosage form: Tablet Route of Administration: Oral
      Other: Placebo (Part A)

        What is the study measuring?

        Primary Outcome

        MeasureDescriptionTime Frame
        To assess the safety and tolerability of IPG7236 after ascending single oral doses through adverse events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events v5Not SpecifiedUp to 36 days
        To assess the safety and tolerability of IPG7236 after ascending multiple oral doses through adverse events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events v5Not SpecifiedUp to 45 days

        Secondary Outcome

        MeasureDescriptionTime Frame
        To assess the pharmacokinetic (PK) parameters of IPG7236 after ascending single oral dosesPlasma PK parameters: Cmax (maximum plasma concentration)Up to 36 days
        To assess the pharmacokinetic (PK) parameters of IPG7236 after ascending single oral dosesPlasma PK parameters: Tmax (time to Cmax)Up to 36 days
        To assess the pharmacokinetic (PK) parameters of IPG7236 after ascending multiple oral dosesPlasma PK parameters: Css,max (maximum plasma concentration at steady state)Up to 45 days
        To assess the pharmacokinetic (PK) parameters of IPG7236 after ascending multiple oral dosesPlasma PK parameters: CTss,max (time to maximum plasma concentration at steady state)Up to 45 days
        To evaluate the effect of food on the PK of IPG7236Pharmacokinetics parameters using Cmax (maximum plasma concentration)Up to 45 days
        Are you running this trial?If you're a clinic or sponsor, you can claim this study.
        Claim this trial

        References

        Clinical Trials Gov: A Study of Orally Administered IPG7236 in Healthy Adult Participants

        Other trials to consider

        Loading suggested trials...

        Top searched conditions

        Breast CancerLung CancerType 2 DiabetesDermatitisAlzheimersParkinsonsLupusCrohn’s DiseaseAsthmaHypertensionCOPDMultiple SclerosisOsteoarthritisHIV/AIDSPsoriasisStrokeObesityProstate CancerDepressionCardiovascular