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NCT05330455
Study of GSK3965193 in Healthy Participants and Participants Living With Chronic Hepatitis B Infection
Phase 1, PHASE2 trial testing GSK3965193 in Hepatitis B in 74 participants. Participants enrolled and being followed up; not accepting new ones.
19 May 2025
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 74 |
| Start date | 14 April 2022 |
| Primary completion | 19 May 2025 |
| Estimated completion | 3 April 2026 |
| Sites | 16 locations across France, Italy, United Kingdom, South Korea, Canada, Thailand |
Drugs / interventions tested
- GSK3965193 — full drug profile →
- Placebo to match GSK3965193 — full drug profile →
- Bepirovirsen — full drug profile →
Conditions studied
- Hepatitis B — all drugs for Hepatitis B →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
Adults 18 to 65, any sex, with Hepatitis B. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This Phase 1/2a multiple part study is a first time-in-human (FTIH) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single (Part 1) and repeat doses (Part 2) of GSK3965193 in healthy participants. Part 3 will evaluate the ability of GSK3965193 to lower hepatitis B virus surface antigen (HBsAg) in participants living with chronic hepatitis B infection (PLWCHB) and will be given the option to subsequently receive treatment with open label bepirovirsen. Part 4 will evaluate the safety and tolerability of combination therapy with GSK3965193 and bepirovirsen and the potential to effect sustained virologic response in PLWCHB.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Landscape of small nucleic acid therapeutics: moving from the bench to the clinic as next-generation medicines.
Liu M, Wang Y, Zhang Y, Hu D, et al · · 2025 · cited 62× · PMID 40059188 · DOI 10.1038/s41392-024-02112-8 -
Hepatocyte targeting <i>via</i> the asialoglycoprotein receptor.
Ramírez-Cortés F, Ménová P. · · 2025 · cited 22× · PMID 39628900 · DOI 10.1039/d4md00652f -
Preclinical Antiviral and Safety Profiling of the HBV RNA Destabilizer AB-161.
Lam AM, Dugyala RR, Sheraz M, Liu F, et al · · 2024 · cited 10× · PMID 38543689 · DOI 10.3390/v16030323 -
Current status and challenges of therapeutic targets, novel drugs and delivery systems for hepatitis B: how far to our goal?
Liao Y, Lv F, Zhou M, Shen J, et al · · 2025 · PMID 41613597 · DOI 10.3389/fcimb.2025.1692924 -
[Clinical research advances for small-molecule nucleic acid drugs in the treatment of chronic hepatitis B].
Wang WX, Guo YM, Fei ZX, Zhu SS, et al · · 2025 · PMID 41461559 · DOI 10.3760/cma.j.cn501113-20250114-00026
Verify or expand the search:
- PubMed search for NCT05330455
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other GlaxoSmithKline trials
Trials by the same sponsor.
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- NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
- NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
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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 NCT05330455 (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 GlaxoSmithKline
- Last refreshed: 19 August 2025
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/NCT05330455.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing