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

NCT07762027

Not Yet RecruitingPhase 2

Sponsor: Assembly Biosciences

Conditions: Chronic Hepatitis D Infection

Interventions: ABI-6250, ABI-6250

Countries: France, Georgia, Germany, Italy, Moldova, New Zealand, Pakistan, Romania

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

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Locations (22)

Clichy, France
Créteil, France
Lyon, France
Tbilisi, Georgia
Hamburg, Germany
Hanover, Germany
Milan, Italy
Naples, Italy
Chisinau, Moldova
Auckland, New Zealand
Karachi, Pakistan
Karachi, Pakistan
Bucharest, Romania
Bucharest, Romania
Bucharest, Romania
Bucharest, Romania
Zaragoza, Spain
Ivano-Frankivsk, Ukraine
Kyiv, Ukraine
London, United Kingdom
London, United Kingdom
Manchester, United Kingdom