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NCT05790694
A Trial of HBM9378 in Healthy Chinese Subjects
Phase 1 trial testing HBM9378 (SKB378) Injection in Asthma in 50 participants. Status unknown.
22 September 2023
Quick facts
| Lead sponsor | Harbour BioMed (Guangzhou) Co. Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 26 August 2022 |
| Primary completion | 22 September 2023 |
| Estimated completion | 22 September 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- HBM9378 (SKB378) Injection — full drug profile →
- Placebo
Conditions studied
- Asthma — all drugs for Asthma →
Sponsor
Harbour BioMed (Guangzhou) Co. Ltd. — full company profile →
Who can join
Adults 18 to 50, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective is to evaluate the safety, tolerability and pharmacokinetic profile of a single subcutaneous injection of HBM9378 (SKB378) at different doses in healthy Chinese subjects.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Safety, Tolerability, and Pharmacokinetics of HBM9378 (SKB378/WIN378), a Fully Human IgG1 Monoclonal Antibody Against TSLP After Single Ascending Doses in Chinese Healthy Subjects.
Yang X, Xu M, Cao N, Zhao S, et al · · 2026 · PMID 41873335 · DOI 10.2147/dddt.s538649
Verify or expand the search:
- PubMed search for NCT05790694
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Harbour BioMed (Guangzhou) Co. Ltd. trials
Trials by the same sponsor.
- NCT05332210 — Evaluate the Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis · Phase 3 · unknown
- NCT05167071 — HBM4003 Combine With Toripalimab in Patients With Advanced NEN and Other Solid Tumors Study · Phase 1 · active not recruiting
- NCT05149027 — A Study to Evaluate Safety, Tolerability, PK/PD and Preliminary Efficacy of HBM4003 Combine With Toripalimab in Patients · Phase 1 · unknown
- NCT05039190 — Evaluate the Efficacy and Safety of HBM9161(HL161)Subcutaneous Injection in Patients With Generalized MG Patients · Phase 3 · completed
- NCT04633213 — A Study Evaluating HBM9036 Efficacy and Safety on Moderate to Severe Dry Eye · Phase 3 · 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 NCT05790694 (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 Harbour BioMed (Guangzhou) Co. Ltd.
- Last refreshed: 30 March 2023
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/NCT05790694.
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