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NCT05470829

A Multiple-dose Study in Chinese Subjects to Evaluate Safety,Tolerability,PK and PD of ZM-H1505R

Completed Phase 1 Last updated 22 July 2022
What this trial tests

Phase 1 trial testing ZM-H1505R in Healthy Volunteers in 42 participants. Completed in 17 November 2021.

Timeline
27 May 2021
Primary endpoint
17 November 2021
17 November 2021

Quick facts

Lead sponsorShanghai Zhimeng Biopharma, Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment42
Start date27 May 2021
Primary completion17 November 2021
Estimated completion17 November 2021
Sites1 location across China

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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:

Other trials of ZM-H1505R

Trials testing the same drug.

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

Other Shanghai Zhimeng Biopharma, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

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