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NCT05470829
A Multiple-dose Study in Chinese Subjects to Evaluate Safety,Tolerability,PK and PD of ZM-H1505R
Phase 1 trial testing ZM-H1505R in Healthy Volunteers in 42 participants. Completed in 17 November 2021.
17 November 2021
Quick facts
| Lead sponsor | Shanghai Zhimeng Biopharma, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 27 May 2021 |
| Primary completion | 17 November 2021 |
| Estimated completion | 17 November 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- ZM-H1505R — full drug profile →
- ZM-H1505R Placebo
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
- Hepatitis B, Chronic — all drugs for Hepatitis B, Chronic →
Sponsor
Shanghai Zhimeng Biopharma, Inc. — full company profile →
Who can join
Adults 18 to 65, any sex, with Healthy Volunteers or Hepatitis B, Chronic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase Ib study included two parts in which Part I was to evaluate the safety and bridge for PK among healthy Chinese subjects and Part II were about study among Chinese chronic hepatitis B virus-infected patients. Study of Part II was carried out following the safety assessment and racial difference evaluation in Part I.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
The premise of capsid assembly modulators towards eliminating HBV persistence.
Bassit L, Amblard F, Patel D, Biteau N, et al · · 2023 · cited 19× · PMID 37477111 · DOI 10.1080/17460441.2023.2239701 -
Safety, tolerability, pharmacokinetics, and antiviral activity of the novel core protein allosteric modulator ZM-H1505R (Canocapavir) in chronic hepatitis B patients: a randomized multiple-dose escalation trial.
Jia H, Mai J, Wu M, Chen H, et al · · 2023 · cited 15× · PMID 36927420 · DOI 10.1186/s12916-023-02814-w -
Biology of the hepatitis B virus (HBV) core and capsid assembly modulators (CAMs) for chronic hepatitis B (CHB) cure.
McFadden WM, Sarafianos SG. · · 2023 · cited 9× · PMID 37655181 · DOI 10.35772/ghm.2023.01065
Verify or expand the search:
- PubMed search for NCT05470829
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ZM-H1505R
Trials testing the same drug.
- NCT05484466 — A Study to Evaluate the Efficacy and Safety of ZM-H1505R in Combination With ETV Compared With ETV Monotherapy in Patien · Phase 2 · unknown
- NCT04220801 — A Study of Orally Administered ZM-H1505R to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple · Phase 1 · completed
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Currently open trials in the same condition.
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Other Shanghai Zhimeng Biopharma, Inc. trials
Trials by the same sponsor.
- NCT05828745 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CB06-036 in Subjects With Chroni · Phase 1 · completed
- NCT06101316 — A Bridging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CB06-036 in Healthy Subjects in China · Phase 1 · unknown
- NCT05502549 — A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CB03-154 in Healthy Participants in Australia · Phase 1 · completed
- NCT05484466 — A Study to Evaluate the Efficacy and Safety of ZM-H1505R in Combination With ETV Compared With ETV Monotherapy in Patien · Phase 2 · unknown
- NCT05499260 — A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CB03-154 in Healthy Participants · Phase 1 · unknown
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 NCT05470829 (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 Shanghai Zhimeng Biopharma, Inc.
- Last refreshed: 22 July 2022
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/NCT05470829.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing