A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Healthy Participants

Assembly Biosciences

Status and phase: Completed; Phase 1

Conditions: Hepatitis D; Hepatitis Delta Virus

Treatments: Drug: Placebo; Drug: ABI-6250

Study type: Interventional

Funder types: Industry

Identifiers

NCT06740474

ABI-6250-101

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 6 patient groups, including a placebo group

Part A: SAD Cohorts 1-5, ABI-6250

Experimental group

Part A: SAD Cohorts 1-5, Placebo

Placebo Comparator group

Part A: SAD Food Effect Cohort 6 or 7: ABI-6250

Experimental group

Treatment:

Drug: ABI-6250

Part A: SAD Food Effect Cohort 6 (if applicable): Placebo

Placebo Comparator group

Part B: MAD Cohorts 1-4, ABI-6250

Experimental group

Part B: MAD Cohorts 1-4, Placebo

Placebo Comparator group

Treatment:

Drug: Placebo