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NCT04536532
Evaluation HEC121120 Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study
Phase 1, PHASE2 trial testing HEC121120 tablets in Hepatitis B, Chronic in 52 participants. Terminated before completion.
12 March 2023
Quick facts
| Lead sponsor | Sunshine Lake Pharma Co., Ltd. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 52 |
| Start date | 9 October 2020 |
| Primary completion | 12 March 2023 |
| Estimated completion | 12 March 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- HEC121120 tablets — full drug profile →
- HEC121120 placebo tablets
- entecavir tablets — full drug profile →
- entecavir placebo tablets
Conditions studied
- Hepatitis B, Chronic — all drugs for Hepatitis B, Chronic →
Sponsor
Sunshine Lake Pharma Co., Ltd. — full company profile →
Who can join
Adults 18 to 65, any sex, with Hepatitis B, Chronic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The Safety, Tolerability, Pharmacokinetics and antiviral activity Study of Anti hepatitis B virus treatment drug HEC121120 in Healthy subjects and in patients with chronic hepatitis B
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04536532
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hepatitis B, Chronic
Currently open trials in the same condition.
- NCT07370207 — Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region · Phase 2 · recruiting
- NCT06550622 — Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion · recruiting
- NCT06550128 — Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB). · Phase 2 · active not recruiting
- NCT06525909 — A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B · recruiting
- NCT05937178 — Real-world Study Optimizing Nucleotide-analogues · recruiting
Other Sunshine Lake Pharma Co., Ltd. trials
Trials by the same sponsor.
- NCT07341672 — A Single-center, Randomized, Open-label, Parallel-design Clinical Study to Evaluate the Pharmacokinetic Effects of Itrac · Phase 1 · not yet recruiting
- NCT05048368 — Pharmacokinetics Study of Larotinib in Subjects With Impaired Hepatic Function · Phase 1 · not yet recruiting
- NCT07376200 — Single-ascending Dose Study of HEC-151 Injection · Phase 1 · not yet recruiting
- NCT07082842 — Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF · Phase 3 · not yet recruiting
- NCT07211165 — Clinical Study on the Mass Balance of Clifutinib · 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 NCT04536532 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sunshine Lake Pharma Co., Ltd.
- Last refreshed: 24 June 2024
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/NCT04536532.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing