Actively Recruiting
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BSY001 After Single/Multiple Doses.
Led by China National Biotec Group Company Limited · Updated on 2026-01-29
76
Participants Needed
1
Research Sites
24 weeks
Total Duration
On this page
Sponsors
C
China National Biotec Group Company Limited
Lead Sponsor
B
Beijing Institute of Biological Products Co Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BSY001 After Single/Multiple Doses.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteers willing to participate, sign consent, and follow study rules
- Ages 18 to 50 years, male or female
- Body Mass Index between 19.0 and 30.0 kg/m²
- Female weight between 45.0 and 120.0 kg; male weight between 50.0 and 120.0 kg
- Willing to use effective contraception from 1 month before screening to 6 months after last dose and no plans for childbearing, sperm or egg donation during this time
You will not qualify if you...
- Allergy to Tecovirimat drugs or related substances, or allergic to two or more types of substances
- Abnormal electrocardiogram results or prolonged QTc interval (≥450 ms in males, ≥470 ms in females)
- Creatinine clearance rate below 90 mL/min
- Significant abnormalities in physical exam, vital signs, lab tests, or other exams
- History or current significant diseases of heart, lungs, digestive, urinary, endocrine, immune, or nervous systems
- Recent (within 3 months) bacterial, fungal, or mycobacterial infection
- Known significant acute or chronic viral infections
- History of severe headache or migraine
- Major surgery within 6 months before dosing or planned surgery within 1 month after trial end
- Blood donation or major blood loss (>450 mL) within 3 months before screening
- Smoking more than 5 cigarettes per day within 3 months before consent or inability to avoid tobacco during trial
- Consuming more than 14 units of alcohol per week within 3 months before consent or inability to abstain during trial
- Consumption of grapefruit, caffeine-containing beverages, or alcohol within 72 hours before dosing or refusal to stop during trial
- Planning strenuous exercise including contact or collision sports during trial
- Positive urine drug screen or history of drug abuse within 5 years before screening
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- Participation in other drug trials within 3 months before screening
- Use of prescription, over-the-counter, or herbal medicines within 30 days before screening
- Positive pregnancy test
- Fear of needles or inability to tolerate blood draws
- Acute illness or need for medication from screening to first dose
- Vaccination within 2 weeks before screening or plans to vaccinate during trial
- Investigator judgment of unsuitability for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shulan (Hangzhou) Hospital
Hangzhou, China
Actively Recruiting
Research Team
W
Wei Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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