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RECRUITING
NCT07377175
PHASE1

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

Sponsor: China National Biotec Group Company Limited

View on ClinicalTrials.gov

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

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

76

Start Date

2025-08-28

Completion Date

2026-02-13

Last Updated

2026-01-29

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Shulan (Hangzhou) Hospital

Hangzhou, China