15 completed, 6 terminated, 2 not yet recruiting. 15 Phase 1, 9 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 15 | Completed 13, Not yet recruiting 1, Terminated 1 |
| Phase 2 | 9 | Terminated 5, Completed 3, Not yet recruiting 1 |
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Participants With Mild Hepatic Impairment Compared With Participants With Normal Hepatic Function ABI-6250 - Mild Hepatic Imparement | Phase 1 | Not yet recruiting | Assembly Biosciences | 20 | 2026-10-01 | 2026-10-16 |
| A Study to Assess the Safety, Pharmacokinetics, and Efficacy of ABI-6250 in Participants With Chronic Hepatitis D Virus Infection ABI-6250 - Chronic Hepatitis D Infection | Phase 2 | Not yet recruiting | Assembly Biosciences | 80 | 2026-10-01 | 2026-08-13 |
| A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Healthy Participants ABI-6250, Placebo - Hepatitis Delta Virus, Hepatitis D | Phase 1 | Completed | Assembly Biosciences | 40 | 2025-01-31 | 2025-12-04 |
| A Study to Assess the Safety, Pharmacokinetics, and Tolerability of ABI-1179 in Healthy Subjects and in Subjects Seropositive for HSV-2 With Recurrent Genital Herpes ABI-1179, ABI-1179 Placebo - Recurrent Genital Herpes Simplex Type 2 | Phase 1 | Completed | Assembly Biosciences | 103 | 2024-12-08 | 2026-03-23 |
| A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B Virus Infection ABI-4334, Placebo - Chronic Hepatitis B | Phase 1 | Completed | Assembly Biosciences | 20 | 2024-06-04 | 2025-07-23 |
| A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-5366 in Healthy Participants and Participants Seropositive for HSV-2 With Recurrent Genital Herpes ABI-5366, ABI-5366 Placebo - Recurrent Genital Herpes Simplex Type 2 | Phase 1 | Completed | Assembly Biosciences | 115 | 2024-05-30 | 2026-03-30 |
| A First in Human Study to Assess Safety, Tolerability, Pharmacokinetics of ABI-4334 in Healthy Subjects ABI-4334 Tablet, ABI-4334 Placebo - Chronic Hepatitis B | Phase 1 | Completed | Assembly Biosciences | 54 | 2022-11-11 | 2023-09-13 |
| A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection ABI-H3733, Placebo - Chronic Hepatitis B | Phase 1 | Completed | Assembly Biosciences | 31 | 2022-08-07 | 2023-06-29 |
| A Study Evaluating Treatment Regimens Containing Vebicorvir (ABI-H0731) in Participants With Chronic Hepatitis B Infection VBR, AB-729, SOC NrtI - Chronic Hepatitis B | Phase 2 | Terminated | Assembly Biosciences | 65 | 2021-05-07 | 2023-11-14 |
| A Study Evaluating ABI-H0731-containing Regimens in Chinese Participants With Chronic Hepatitis B Virus Infection ABI-H0731, ETV, Peg-IFNα - Chronic Hepatitis B | Phase 2 | Terminated | Assembly Biosciences | 54 | 2021-02-18 | 2023-10-06 |
| A Study to Evaluate the Mass Balance Absorption and AME of VBR Vebicorvir (VBR) - Chronic Hepatitis B | Phase 1 | Completed | Assembly Biosciences | 6 | 2020-12-01 | 2021-01-12 |
| A Study Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors ABI-H0731, Placebo, NrtI - Chronic Hepatitis B | Phase 2 | Terminated | Assembly Biosciences | 2 | 2020-11-11 | 2022-10-20 |
| A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection ABI-H2158, Placebo, Entecavir (ETV) - Chronic Hepatitis B | Phase 2 | Terminated | Assembly Biosciences | 88 | 2020-08-28 | 2022-09-15 |
| A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABI-H3733 in Healthy Adults ABI-H3733 Liquid Oral Dosage Form, ABI-H3733 Solid Oral Dosage Form, Placebo to ABI-H3733 Liquid Oral Dosage Form - Chronic Hepatitis B | Phase 1 | Completed | Assembly Biosciences | 120 | 2020-05-17 | 2021-01-27 |
| A Study to Assess CYP3A4 Modulator, Oral Contraceptive, and pH Modifier Drug Interactions for ABI-H2158 in Healthy Adults ABI-H2158, Itraconazole, Rifampin - Chronic Hepatitis B | Phase 1 | Completed | Assembly Biosciences | 80 | 2019-10-18 | 2020-03-04 |
| A Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adults ABI-H2158 Reference Formulation, ABI-H2158 Test Formulation - Chronic Hepatitis B | Phase 1 | Completed | Assembly Biosciences | 15 | 2019-09-06 | 2019-11-29 |
| ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis ABI-M201, Placebo - Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate | Phase 1 | Terminated | Assembly Biosciences | 15 | 2019-06-24 | 2021-03-19 |
| A Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients standard of care (SOC) Nucleoside reverse transcriptase inhibitor (NrtI) - Chronic Hepatitis B | Phase 2 | Terminated | Assembly Biosciences | 92 | 2018-12-20 | 2023-04-19 |
| A Study of ABI-H2158 in Healthy Volunteers and Patients With Chronic Hepatitis B ABI-H2158, Placebo for ABI-H2158 - Chronic Hepatitis B | Phase 1 | Completed | Assembly Biosciences | 80 | 2018-11-13 | 2021-01-27 |
| A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV) ABI-H0731, SOC ETV, Placebo Oral Tablet - Chronic Hepatitis B | Phase 2 | Completed | Assembly Biosciences | 25 | 2018-06-19 | 2021-01-28 |
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Hepatitis B, Chronic (17) · Hepatitis B (9) · Herpes Genitalis (2) · Hepatitis D (1)
entecavir (8) · Tenofovir (5) · tenofovir alafenamide (3) · peginterferon alfa-2a (2) · Esomeprazole (1) · Ethinyl Estradiol-Norgestrel Combination (1) · Itraconazole (1) · Midazolam (1) · Rifampin (1) · Standard of Care (1) · Sugars (1)
New Zealand (17) · United States (11) · Hong Kong (7) · Australia (6) · Canada (6) · United Kingdom (6) · China (3) · Moldova (3) · South Korea (3) · Bulgaria (2) · Romania (2) · Taiwan (2) · France (1) · Georgia (1) · Germany (1)
Edward Gane (1) · Grace Wang (1) · Grace Wang, MD (1) · Katia Alves, MD (1) · M. F. Yuen, MD, PhD, DSc (1) · Marc Evanchik (1) · Michele Anderson (1) · Steven Knox (1)
PMID 31711752, PMID 34029994, PMID 35460726, PMID 35697332, PMID 38510983
2019 (1)