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NCT05542979
A Study to Evaluate the Safety, Tolerability of HH-003 Injection in Participants With Chronic Hepatitis B Virus Infection
Phase 1 trial testing HH-003 injection in Chronic HBV Infection in 68 participants. Completed in 15 March 2022.
15 March 2022
Quick facts
| Lead sponsor | Huahui Health |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 68 |
| Start date | 5 August 2019 |
| Primary completion | 15 March 2022 |
| Estimated completion | 15 March 2022 |
| Sites | 11 locations across China |
Drugs / interventions tested
- HH-003 injection — full drug profile →
- Placebo
Conditions studied
- Chronic HBV Infection — all drugs for Chronic HBV Infection →
Sponsor
Huahui Health — full company profile →
Who can join
Adults 18 to 45, any sex, with Chronic HBV Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multicenter, randomized, double-blind, placebo-controlled, multiple-ascending dose phase Ib study of HH-003 injection, which is a monoclonal antibody targeting Hepatitis B virus. This study aims to evaluate the safety, tolerability and pharmacokinetics of HH-003 injection in treatment-naive participants chronically infected with hepatitis B virus.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
The progress of molecules and strategies for the treatment of HBV infection.
Pan Y, Xia H, He Y, Zeng S, et al · · 2023 · cited 33× · PMID 37009498 · DOI 10.3389/fcimb.2023.1128807 -
Monoclonal antibody applications in travel medicine.
de Jong HK, Grobusch MP. · · 2024 · cited 8× · PMID 38221606 · DOI 10.1186/s40794-023-00212-x
Verify or expand the search:
- PubMed search for NCT05542979
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Huahui Health trials
Trials by the same sponsor.
- NCT07519330 — Clinical Study to Evaluate the Efficacy and Safety of HH-006 in Patients With Chronic Hepatitis B Virus Infection · Phase 2 · not yet recruiting
- NCT07499544 — A Phase III Study to Evaluate the Efficacy and Safety of Libevitug in Participants With Chronic HDV Infection (D-clear S · Phase 3 · not yet recruiting
- NCT07515209 — A Clinical Study of HH-006 in Untreated Chronic Hepatitis B Virus Infected Patients · Phase 1 · completed
- NCT05861674 — A Study to Assess Efficacy and Safety of HH-003 Injection in Subjects With Chronic Hepatitis Delta Virus Infection · Phase 2 · completed
- NCT05787418 — HH-120 Nasal Spray for Post-exposure Prevention of SARS-CoV-2 · Phase 3 · enrolling by invitation
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 NCT05542979 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Huahui Health
- Last refreshed: 16 September 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/NCT05542979.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing