NCT07377175

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BSY001 After Single/Multiple Doses.

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.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: China National Biotec Group Company Limited · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This study is divided into two parts: a single-dose study (BSY001-A) and a multiple-dose study (BSY001-B). Subjects for BSY001-B will be enrolled only after all subjects participating in BSY001-A have completed the pharmacokinetic (PK) tests and safety follow-ups for all dose groups, and the corresponding PK parameters and preliminary safety results have been obtained. BSY001-A: A single ascending dose study conducted in healthy subjects. The trial includes five dose groups: 37.5, 75, 150, 200, and 300 mg, starting from the low-dose group. A total of 46 subjects are planned for enrollment. For the 37.5 mg and 75 mg dose groups, 8 subjects will be enrolled in each group, with 6 receiving BSY001 for injection and 2 receiving placebo. For the 150 mg, 200 mg, and 300 mg dose groups, 10 subjects will be enrolled in each group, including 8 receiving BSY001 for injection and 2 receiving placebo. All subjects will receive a single administration of either BSY001 for injection or placebo. PK blood samples will be collected both prior to and after the initiation of dosing. Subjects who complete PK blood sampling and safety follow-ups may be discontinued from the study. Tolerability assessment will be performed on Day 4 for each dose group, and dosing of the next dose group may commence only after the Safety Monitoring Committee (SMC) confirms safety and tolerability. BSY001-B: A randomized, double-blind, multiple-dose pharmacokinetic study conducted in healthy subjects. A total of 30 eligible subjects will be enrolled after screening, including 24 in the treatment group and 6 in the placebo group. Subjects will receive 200 mg of BSY001 for injection or placebo, administered once every 12 hours ± 10 minutes for 14 consecutive days. During hospitalization, subjects will be under centralized management by the study center, with blood sample collection and safety assessments performed as scheduled.

Conditions

• Smallpox
• Cowpox
• Monkeypox
• Poxvirus Infection

Interventions

Type	Name	Description
DRUG	BSY001 for Injection (37.5mg)	A single dose of 37.5mg BSY001 for injection.
DRUG	BSY001 for Injection (75 mg)	A single dose of 75 mg BSY001 for injection.
DRUG	BSY001 for Injection (150 mg)	A single dose of 150 mg BSY001 for injection.
DRUG	BSY001 for Injection (200 mg)	A single dose of 200 mg BSY001 for injection.
DRUG	BSY001 for Injection (300 mg)	A single dose of 300 mg BSY001 for injection.
DRUG	placebo-SAD	A single dose for injection.
DRUG	BSY001 for Injection	Administer 200 mg of BSY001 every 12 hours for 14 consecutive days.
DRUG	placebo-MAD	Administer placebo every 12 hours for 14 consecutive days.

Timeline

• Start date: 2025-08-28
• Primary completion: 2026-02-13
• Completion: 2026-02-13
• First posted: 2026-01-29
• Last updated: 2026-01-29

Locations

1 site across 1 country: China