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

NCT07377175 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-01-29

No results posted yet for this study

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

Conditions

  • Smallpox
  • Cowpox
  • Monkeypox
  • Poxvirus Infection

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.

Sponsors & Collaborators

  • Beijing Institute of Biological Products Co Ltd.

    collaborator INDUSTRY

  • Shulan (Hangzhou) Hospital

    collaborator OTHER

  • China National Biotec Group Company Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-28
Primary Completion
2026-02-13
Completion
2026-02-13

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07377175 on ClinicalTrials.gov