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NCT03288636
Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China
Phase 1 trial testing Danoprevir in HCV in 18 participants. Completed in 28 October 2017.
14 September 2017
Quick facts
| Lead sponsor | Ascletis Pharmaceuticals Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 8 August 2017 |
| Primary completion | 14 September 2017 |
| Estimated completion | 28 October 2017 |
| Sites | 1 location across China |
Drugs / interventions tested
- Danoprevir — full drug profile →
- Ritonavir (ritonavir) — full drug profile →
- Ravidasvir — full drug profile →
- Placebo
Conditions studied
- HCV — all drugs for HCV →
Sponsor
Ascletis Pharmaceuticals Co., Ltd. — full company profile →
Who can join
Adults 18 to 45, any sex, with HCV. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to investigate the Pharmacokinetics and Safety of single dose of Ravidasvir and Danoprevir/r and repeated doses of Ravidasvir in combination with Danoprevir/r in healthy volunteers.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Progress, evolving therapeutic/diagnostic approaches, and challenges in the management of hepatitis C virus infections.
Meshram RJ, Kathwate GH, Gacche RN. · · 2022 · cited 9× · PMID 35089390 · DOI 10.1007/s00705-022-05375-0 -
Pharmacokinetics, Safety, and Tolerability of Ravidasvir, with and without Danoprevir/Ritonavir, in Healthy Subjects.
Wu G, Zhou H, Wu J, Lv D, et al · · 2021 · cited 2× · PMID 34252301 · DOI 10.1128/aac.00600-21
Verify or expand the search:
- PubMed search for NCT03288636
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Danoprevir
Trials testing the same drug.
- NCT03362814 — Efficacy and Safety of Ravidasvir in Combination With Danoprevir/r and Ribavirin(RBV) in Treatment-naive, Non-cirrhotic, · Phase 2, PHASE3 · completed
- NCT03020134 — Pharmacokinetics and Safety of Ravidasvir and Danoprevir/r in Healthy Volunteers China · Phase 1 · completed
Other recruiting trials for HCV
Currently open trials in the same condition.
- NCT07095192 — Scaling Up Point-of-Care Hepatitis C Testing and Treatment in Canada · recruiting
- NCT06316739 — The Ganchero Intervention for Migrant People Who Inject Drugs From Puerto Rico in New York City · NA · active not recruiting
- NCT05794646 — Community Intervention to Eliminate HCV Among People Who Use Drugs. · NA · active not recruiting
- NCT06528626 — Tools to Identify People At Risk or Already Infected with HIV and HCV · NA · recruiting
- NCT05781568 — Use of Blood Biomarkers for the Early Diagnosis of Hepatocellular Carcinoma (HCC) · recruiting
Other Ascletis Pharmaceuticals Co., Ltd. trials
Trials by the same sponsor.
- NCT06248008 — A Study to Evaluate Safety of ASC40 Tablets in Patients With Moderate to Severe Acne Vulgaris · Phase 3 · completed
- NCT06192264 — A Study to Evaluate the Safety and Efficacy of ASC40 (Denifanstat) Tablets in the Treatment of Patients With Moderate to · Phase 3 · completed
- NCT05718518 — Study to Evaluate Safety, Tolerability, PK and the Food Effect on PK of ASC11/RTV Tablets in Healthy Subjects · Phase 1 · completed
- NCT05596045 — Study to Evaluate Safety, Tolerability, Efficacy and Pharmacokinetics of ASC10 in Mild to Moderate COVID-19 Patients · Phase 1 · withdrawn
- NCT05523141 — Study to Evaluate Safety, Tolerability, Pharmacokinetics and the Food Effect on PK of ASC10 Tablets in Healthy Subjects · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03288636 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ascletis Pharmaceuticals Co., Ltd.
- Last refreshed: 17 January 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03288636.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing