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.
China National Biotec Group Company Limited
76 participants
Aug 28, 2025
INTERVENTIONAL
Conditions
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
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
A single dose of 37.5mg BSY001 for injection.
A single dose of 75 mg BSY001 for injection.
A single dose of 150 mg BSY001 for injection.
A single dose of 200 mg BSY001 for injection.
A single dose of 300 mg BSY001 for injection.
A single dose for injection.
Administer 200 mg of BSY001 every 12 hours for 14 consecutive days.
Administer placebo every 12 hours for 14 consecutive days.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07377175