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NCT07377175
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BSY001 After Single/Multiple Doses.
Phase 1 trial testing BSY001 for Injection (37.5mg) in Smallpox in 76 participants. Currently enrolling.
13 February 2026
Quick facts
| Lead sponsor | China National Biotec Group Company Limited |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 76 |
| Start date | 28 August 2025 |
| Primary completion | 13 February 2026 |
| Estimated completion | 13 February 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- BSY001 for Injection (37.5mg) — full drug profile →
- BSY001 for Injection (75 mg) — full drug profile →
- BSY001 for Injection (150 mg) — full drug profile →
- BSY001 for Injection (200 mg) — full drug profile →
- BSY001 for Injection (300 mg) — full drug profile →
- placebo-SAD
- BSY001 for Injection
- placebo-MAD
Conditions studied
- Smallpox — all drugs for Smallpox →
- Cowpox — all drugs for Cowpox →
- Monkeypox — all drugs for Monkeypox →
- Poxvirus Infection — all drugs for Poxvirus Infection →
Sponsor
China National Biotec Group Company Limited — full company profile →
Who can join
Adults 18 to 50, any sex, with Smallpox or Cowpox. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Two-Phase, Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BSY001 for Injection Following Single or Multiple Doses in Healthy Subjects
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07377175
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Smallpox
Currently open trials in the same condition.
- NCT04957485 — Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS · Phase 2 · active not recruiting
Other China National Biotec Group Company Limited trials
Trials by the same sponsor.
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- NCT05839301 — A Trial to Evaluate the Lot-to-lot Consistency of Live Attenuated Varicella Vaccine in Healthy People 1-12 Years of Age · Phase 3 · unknown
- NCT05669625 — A Phase III Clinical Trial to Evaluate the Efficacy and Safety of the Live Attenuated Varicella Vaccine · Phase 3 · active not recruiting
- NCT05480436 — Immunogenicity and Safety of BBIBP-Corv Coadministered With PPV23 and IIV4 in Hemodialysis Population · Phase 4 · unknown
- NCT05453487 — Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine (Sinopharm BBIBP-CorV) Coadministered With Rabies Vaccine · Phase 4 · 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 NCT07377175 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by China National Biotec Group Company Limited
- Last refreshed: 29 January 2026
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/NCT07377175.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing