Trials / Terminated
TerminatedNCT04847440
A Study of Safety and Efficacy of ATI-2173 in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection and in Subjects With Hepatitis D Virus Coinfection
A Phase 2A Randomized, Double-blinded, Placebo-controlled, Multicenter, Dose Ranging Study of Safety and Efficacy of ATI-2173 in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection and in Subjects With Hepatitis D Virus Coinfection
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Antios Therapeutics, Inc · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, double-blinded, placebo-controlled, multi center, dose ranging study of safety and efficacy in both volunteers with chronic hepatitis B virus infection and in volunteers with hepatitis D virus coinfection. Volunteers will be administered multiple oral doses of ATI-2173 and assessed for safety and efficacy including blood tests to show how the body metabolizes and eliminates the investigational drug as well as how the drug effects the virus infection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ATI-2173 | ATI-2173 is a liver-targeted phosphoramidate prodrug of clevudine designed to enhance anti-HBV activity while decreasing systemic exposure to clevudine. It will be dosed as a capsule by mouth. Viread is a nucleotide analogue reverse transcriptase inhibitor used for chronic hepatitis B virus. |
| DRUG | Viread | Viread is a nucleotide analogue reverse transcriptase inhibitor used for chronic hepatitis B virus. |
| DRUG | AB-729 | AB-729 is a potent, selective, subcutaneously administered, N-acetylgalactosamine (Ga1NAc)-conjugated small interfering ribonucleic acid (siRNA) inhibitor of HBV |
Timeline
- Start date
- 2021-03-30
- Primary completion
- 2022-09-01
- Completion
- 2022-09-01
- First posted
- 2021-04-19
- Last updated
- 2022-11-18
Locations
2 sites across 2 countries: Moldova, Ukraine
Source: ClinicalTrials.gov record NCT04847440. Inclusion in this directory is not an endorsement.