A Study to Assess the Safety, Pharmacokinetics, and Efficacy of ABI-6250 in Participants With Chronic Hepatitis D Virus Infection

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAssembly Biosciences

About this trial

This study is designed to assess safety, pharmacokinetics, and efficacy ABI-6250 in participants with Chronic Hepatitis D Virus Infection.

Eligibility criteria

Qualifiers

Participant has a body mass index ≥18.0 and <35.0 kg/m2 at Screening

Other than HBV and HDV infection, the participant is in good health (as determined by the Investigator) based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory results.

Participant agrees to comply with protocol-specified contraception requirements.

Disqualifiers

Participant has a current coinfection with acute hepatitis A virus (HAV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).

Participant has a history of any significant food or drug-related allergic reactions such as anaphylaxis, Stevens-Johnson syndrome, or urticaria.

Participant has been treated for HDV infection in the past 6 months prior to Day 1.

Participant took part in another clinical trial of a drug or device (other than for HDV infection) whereby the last study drug/device administration is within 30 days or 5 half-lives, whichever is longer, prior to Day 1.

Trial design

Treatments tested in this trial

  • ABI-6250
  • ABI-6250

Treatment groups

80 Participants
are divided into 4 treatment groups

Sponsors and collaborators