A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Healthy Participants
- Registration Number
- NCT06740474
- Lead Sponsor
- Assembly Biosciences
- Brief Summary
This study is designed to assess safety, tolerability, and pharmacokinetics of single ascending doses (SAD) and multiple-ascending doses (MAD) of ABI-6250 in healthy participants. Effect of food will also be evaluated in Part A.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 78
Inclusion Criteria
- Participant has a body mass index (BMI) between ≥18.0 and <32.0 kg/m2 and is in good health (as determined by the Investigator) based on medical history, physical examination, ECG, and clinical laboratory results.
- Female participants must be non-pregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day-1 or Day 1 (predose).
- Participants must agree to comply with protocol-specified contraceptive requirements.
Exclusion Criteria
- Current infection of human immunodeficiency virus (HIV), hepatitis B virus, (HBV), hepatitis C virus (HCV) or acute hepatitis A virus (HAV).
- History of any illness that, in the opinion of the Investigator, might confound the results of the study, pose an additional risk in administering study drug to the subject, or condition known to interfere with the absorption /distribution/ elimination of drugs.
- History of any significant drug-related allergic reactions such as anaphylaxis, Stevens-Johnson Syndrome, urticaria, or multiple drug allergies.
- History of persistent alcohol abuse or illicit drug abuse within 3 years prior to screening.
- Has participated in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 half-lives before screening, whatever is longer.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A: SAD Cohorts 1-5, ABI-6250 ABI-6250 - Part A: SAD Cohorts 1-5, Placebo Placebo - Part A: SAD Food Effect Cohort 6 or 7: ABI-6250 ABI-6250 - Part A: SAD Food Effect Cohort 6 (if applicable): Placebo Placebo - Part B: MAD Cohorts 1-4, ABI-6250 ABI-6250 - Part B: MAD Cohorts 1-4, Placebo Placebo -
- Primary Outcome Measures
Name Time Method Proportion of subjects with AEs, premature treatment discontinuation due to AEs and abnormal laboratory results From enrollment to 10 days after the last dose, at pre-specified timepoints Area Under the Plasma Concentration Time Curve (AUC) of ABI-6250 From enrollment to 10 days after the last dose, at pre-specified timepoints Maximum Observed Plasma Concentration (Cmax) of ABI-6250 From enrollment to 10 days after the last dose, at pre-specified timepoints Time to Cmax (Tmax) of ABI-6250 From enrollment to 10 days after the last dose, at pre-specified timepoints Apparent Terminal Elimination Half Life (t 1/2) of ABI-6250 From enrollment to 10 days after the last dose, at pre-specified timepoints Apparent Systemic Clearance (CL/F) of ABI-6250 From enrollment to 10 days after the last dose, at pre-specified timepoints Apparent Volume of Distribution (Vz/F) of ABI-6250 From enrollment to 10 days after the last dose, at pre-specified timepoints Dose normalized AUCs and Cmax of ABI-6250 From enrollment to 10 days after the last dose, at pre-specified timepoints
- Secondary Outcome Measures
Name Time Method Comparison of plasma AUC between fasted and fed treatments From enrollment to 10 days after the last dose, at pre-specified timepoints Comparison of AUC between fasted and fed treatments From enrollment to 10 days after the last dose, at pre-specified timepoints
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular targets does ABI-6250 modulate in Hepatitis Delta Virus (HDV) infection, and how does its mechanism differ from nucleoside analogs like lonafarnib?
How does the safety profile of ABI-6250 compare to bulevirtide and JNJ-3977 in early-phase HDV trials?
Which biomarkers (e.g., HDV RNA, HBsAg) correlate with pharmacokinetic responses to ABI-6250 in Phase 1 healthy volunteer studies?
What are the most common adverse events reported in Phase 1 trials of HDV antivirals like ABI-6250, and how are they managed?
Are there ongoing combination therapies involving ABI-6250 and entry inhibitors for Hepatitis D, and what preclinical data support this approach?
Trial Locations
- Locations (1)
New Zealand Clinical Research
🇳🇿Auckland, New Zealand