OverviewStudy detailsEligibilityThings to knowResearchStudy plan
info
Simplify with AI

BF844 Safety and Pharmacokinetic Study in Healthy Volunteers

PHASE1UNKNOWN

First-in-Human Phase-1 Clinical Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Ascending Doses of BF844 when Administered Orally to Healthy Adult Participants.

Study details:

This is a first-in-human, single center, randomized, double-blinded, single and multiple ascending doses (SAD and MAD) and food effect Phase I study in healthy adult volunteers (HV). The SAD cohorts will consist of five cohorts of eight participants (6 randomized to treatment + 2 randomized to placebo) in each cohort (Total 40 HV). Additional cohorts may be added.

The food effect (FE) cohort will consist of 12 participants who receive a single dose of BF844 in a cross-over manner. Each participants will receive the same single dose of BF844 under two separate conditions: one after an overnight fast, and the second following a high-fat breakfast 30 minutes prior to dosing. The MAD cohorts will consist of 3 cohorts of eight participants (6 randomized to treatment + 2 randomized to placebo) in each cohort (Total 24 HV).

The subjects in MAD cohorts will be dosed once daily for 7 consecutive days. Additional cohorts may be added. For each cohort, all HV subjects will be enrolled at the same site To optimise participants safety, BF844 will be administered in a staggered manner as per protocol .

Eligibility criteria

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

Inclusion criteria

  1. Healthy male or female between the ages of 18 and 45 years (inclusive) at the time of Screening. Healthy status will be determined by the Investigator based on medical history, clinical laboratory results, vital sign and electrocardiogram measurements, and physical examination at screening.
  2. Willingness and ability to give personal signed informed consent and comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  3. Weight of at least 45 kg and a body mass index (BMI) ≥ 19.0 and ≤ 32.0 kg/m2 at Screening.
  4. Male participants who are non-sterilized and sexually active with a female partner of childbearing potential must agree to use adequate contraception from the signing of informed consent, throughout the duration of the study, and for 90 days after completion of the study. Male participants must use barrier contraception (e.g., condom). In addition to the male participant using a condom, the female partner of childbearing potential must also be using a highly effective form of contraception (hormonal or non-hormonal). The male participant must be advised and agree not to donate sperm during this period.
  5. Female participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to routinely use highly effective contraception from signing of informed consent, throughout the duration of the study, and for 30 days after completion of the study. A highly effective method of contraception for women of childbearing potential is defined as one that has no higher than a 1% failure rate per year.

Exclusion criteria

  1. Any concomitant disease, condition, or treatment that could interfere with the conduct of the study, or that would, in the opinion of the Investigator or Sponsor, pose an unacceptable risk to the participant in the study or interfere with the interpretation of study data.
  2. Has received any investigational compound within 30 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
  3. Participant who is a study site employee or who is an immediate family member of a study site employee, (e.g., spouse, parent, child, sibling). Any participant under duress during the consent process.
  4. Participant has any clinically significant illness, such as cardiovascular, neurologic, pulmonary, hepatic, renal (estimated or actual GFR less than 90 mL/minute), metabolic, gastrointestinal, urologic, immunologic, endocrine, or psychiatric disease or disorder, or other abnormality, which may affect safety, or potentially confound the study results. It is the responsibility of the Investigator to assess the clinical significance; however, consultation with the Sponsor and/or CRO MM may be warranted.
  5. Participant has a known hypersensitivity to any component of the formulation of BF844.
  6. Participant has a positive urine result for drugs of abuse (defined as any illicit drug use) at Screening or Check-in (Day -1).
  7. Participant who, in the opinion of the Investigator, has a history of excessive alcohol or drug abuse within one year of Screening.
  8. Use of or plans to use medications (e.g., S-warfarin, NSAIDs, phenytoin, omeprazole, and clopidogrel) that are significantly metabolized by CYP2C19/ CYP2C9. Additionally, the use of any medications that could have a significant impact on organ function (e.g., barbiturates, omeprazole, and cimetidine). These drugs are prohibited during the study and within 5 half-lives of the individual agent or within 28 days (whichever is longer) prior to enrollment.
  9. Use or intended use of prescription or non-prescription medications (including vitamins or supplements) from 7 days prior to dosing or 5 half-lives (whichever is greater), unless the Investigator or medical delegate considers that such use would not significantly impact participant safety or study data.
  10. Participant is pregnant or lactating or intending to become pregnant before, during, or within 30 days since the last dose of the study drug; or intending to donate ova during such time.
  11. If male, the participant intends to donate sperm during the course of this study or within 90 days after the last dose of the study drug.
  12. Participant has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (i.e., a history of malabsorption, any surgical intervention known to impact absorption [e.g., bariatric surgery or bowel resection], esophageal reflux, peptic ulcer disease, erosive esophagitis, or frequent [more than once per week] occurrence of heartburn).
  13. Participant has a positive test result for: (i) hepatitis B surface antigen (HBsAg), (ii) hepatitis C virus (HCV) antibody, or (iii) human immunodeficiency virus (HIV) infection at Screening.
  14. Participant has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patches, or nicotine gum) within 28 days prior to Check-in (Day -1). The cotinine test is positive at Screening or Check-in (Day -1) or if the participant is unwilling to abstain from nicotine-containing products throughout the study.
  15. Participant has poor peripheral venous access.
  16. Participant has donated or lost 450 mL or more of his or her blood volume (including plasmapheresis) or had a transfusion of any blood product within 90 days prior to the first dose of the study drug.
  17. Participant has a clinically significant ECG (QTcF ≥; 450 for males and 470 for females) at Screening or Check-in (Day -1). Entry of any participant with an abnormal, but not clinically significant, ECG must be approved, and documented by signature of the Investigator or medical delegate.
  18. Participant has a supine blood pressure outside the ranges of ≥ 90 to ≤ 140 mmHg for systolic and ≥ 40 to ≤ 90 mmHg for diastolic. If out of range, an assessment may be repeated once for eligibility determination at Screening and/or Check-in (Day -1).
  19. Participant has a resting heart rate outside the range of 40 to 100 bpm (not on ECGs). If out of range, the assessment may be repeated once for eligibility determination at Screening and/or Check-in (Day -1).
  20. Participant has abnormal laboratory values at Screening or Check-in (Day -1) that suggest a clinically significant underlying disease or participant has the following lab abnormalities: ALT and/or AST ≥ 1.5x ULN.
  21. Participant is unwilling to avoid strenuous exercise up to 48 hours prior to any safety laboratory blood draws.
  22. Participant is unwilling to abstain from consuming caffeine and/or xanthene products (e.g., coffee, tea, chocolate, and caffeine-containing sodas) while confined to the CRU.

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

NCT06592131

Intervention or treatment

DRUG: BF844

Conditions

  • Usher Syndrome Type 3

  • Condition: Usher Syndrome Type 3

  • DRUG: BF844

  • Perth, Australia, Australia

  • Sponsor: EyeXCel Pty. 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:

Linear Clinical Research

Select from list below to view details:

  • Linear Clinical Research

    Perth, Australia, Australia

Loading map...

Who is running the clinical trial?

EPL

EyeXCel Pty. 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: Cohort-1 First dose of SAD cohort (6 treatment + 2 placebo)
  • Drug: BF844
Drug: BF844
    EXPERIMENTAL: Cohort-2 Second dose of SAD cohort (6 treatment + 2 placebo)
    • Drug: BF844
    Drug: BF844
      EXPERIMENTAL: Cohort-3 Third dose of SAD cohort (6 treatment + 2 placebo)
      • Drug: BF844
      Drug: BF844
        EXPERIMENTAL: Cohort-4 Fourth dose of SAD cohort (6 treatment + 2 placebo)
        • Drug: BF844
        Drug: BF844
          EXPERIMENTAL: Cohort-5 Fifth dose of SAD cohort (6 treatment + 2 placebo)
          • Drug: BF844
          Drug: BF844
            EXPERIMENTAL: Cohort-6 Using one of the BF844 doses(with/without food) that were tested in SAD
            • Drug: BF844
            Drug: BF844
              EXPERIMENTAL: Cohort-7 First dose of MAD cohort (6 treatment + 2 placebo)
              • Drug: BF844
              Drug: BF844
                EXPERIMENTAL: Cohort 8 Second dose of MAD cohort (6 treatment + 2 placebo)
                • Drug: BF844
                Drug: BF844
                  EXPERIMENTAL: Cohort 9 Third dose of MAD cohort (6 treatment + 2 placebo)
                  • Drug: BF844
                  Drug: BF844

                    What is the study measuring?

                    Primary Outcome

                    MeasureDescriptionTime Frame
                    To determine the safety and tolerability of BF844 when administered orally at ascending single and multiple doses to healthy adult participants.Percentage of participants who experience at least 1 treatment-emergent adverse event (TEAE).Baseline and 14 Days
                    To determine the safety and tolerability of BF844 when administered orally at ascending single and multiple doses to healthy adult participants.Percentage of participants who discontinue due to an adverse event (AE).Baseline and 14 Days
                    To determine the safety and tolerability of BF844 when administered orally at ascending single and multiple doses to healthy adult participants.Percentage of participants who meet the clinically significant criteria for safety laboratory tests at least once post dose.Baseline and 14 Days
                    To determine the safety and tolerability of BF844 when administered orally at ascending single and multiple doses to healthy adult participants.Percentage of participants who meet the clinically significant criteria for vital sign measurements at least once post dose.Baseline and 14 Days
                    To determine the safety and tolerability of BF844 when administered orally at ascending single and multiple doses to healthy adult participants.Percentage of participants who meet the clinically significant criteria for safety electrocardiogram (ECG) parameters at least once post dose.Baseline and 14 Days
                    To determine the safety and tolerability of BF844 when administered orally at ascending single and multiple doses to healthy adult participants.Treatment-emergent hearing, vision, or balance abnormalities, as measured by audiometry, visual acuity, and clinical examination.Baseline and 14 Days

                    Secondary Outcome

                    MeasureDescriptionTime Frame
                    To determine the effect of food on the absorption of BF844 when administered as a single oral dose in healthy participants.Plasma PK parameters of BF844 at the dose level selected for the food effect study: t1/2Baseline and 24 hours
                    To determine the PK of BF844 when administered as multiple oral doses at escalating dose levels in healthy participants.Plasma PK parameters of BF844 at each dose level: CmaxBaseline and 7 days
                    To determine the PK of BF844 when administered as multiple oral doses at escalating dose levels in healthy participants.Plasma PK parameters of BF844 at each dose level: AUClastBaseline and 7 days
                    To determine the PK of BF844 when administered as multiple oral doses at escalating dose levels in healthy participants.Plasma PK parameters of BF844 at each dose level: AUC∞Baseline and 7 days
                    To determine the PK of BF844 when administered as multiple oral doses at escalating dose levels in healthy participants.Plasma PK parameters of BF844 at each dose level: t1/2Baseline and 7 days
                    To determine the PK of BF844 when administered as multiple oral doses at escalating dose levels in healthy participants.Urine PK parameters of BF844 at each dose level: AUC0-24hrsBaseline and 7 days
                    To determine the effect of food on the absorption of BF844 when administered as a single oral dose in healthy participants.Plasma PK parameters of BF844 at the dose level selected for the food effect study: CmaxBaseline and 24 hours
                    To determine the effect of food on the absorption of BF844 when administered as a single oral dose in healthy participants.Plasma PK parameters of BF844 at the dose level selected for the food effect study: tmaxBaseline and 24 hours
                    To determine the effect of food on the absorption of BF844 when administered as a single oral dose in healthy participants.Plasma PK parameters of BF844 at the dose level selected for the food effect study: AUClastBaseline and 24 hours
                    To determine the effect of food on the absorption of BF844 when administered as a single oral dose in healthy participants.Plasma PK parameters of BF844 at the dose level selected for the food effect study: AUC∞Baseline and 24 hours
                    To determine the PK of BF844 when administered as multiple oral doses at escalating dose levels in healthy participants.Plasma PK parameters of BF844 at each dose level: tmaxBaseline and 7 days
                    To determine the PK of BF844 when administered as multiple oral doses at escalating dose levels in healthy participants.Plasma PK parameters of BF844 at each dose level: AUCτBaseline and 7 days
                    To determine the PK of BF844 when administered as multiple oral doses at escalating dose levels in healthy participants.Urine PK parameters of BF844 at each dose level: Accumulation factorBaseline and 7 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: BF844 Safety and Pharmacokinetic Study in Healthy Volunteers

                    Other trials to consider

                    Loading suggested trials...

                    Top searched conditions

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