Actively Recruiting
Two-Phase Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety, Tolerability, and Pharmacokinetics of BSY001 Injection After Single and Multiple Doses in Healthy Adults
Led by China National Biotec Group Company Limited · Updated on 2026-01-29
76
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating BSY001 for injection in healthy adults aged 18 to 50 years to assess its safety, tolerability, and how the body processes the drug. This Phase I clinical trial includes two parts: a single-dose study and a multiple-dose study. The study is randomized, double-blind, and placebo-controlled to carefully monitor the effects of BSY001 compared to placebo. It is sponsored by China National Biotec Group Company Limited. The first part, BSY001-A, involves giving single ascending doses of BSY001 or placebo in five groups ranging from 37.5 mg to 300 mg. Each group receives one dose followed by blood tests and safety checks, with dosing of higher groups starting only after safety is confirmed. The second part, BSY001-B, enrolls 30 participants who receive 200 mg of BSY001 or placebo twice daily for 14 days under close hospital supervision, with regular blood sampling and safety assessments. Participants will undergo screening and then receive either BSY001 or placebo according to their group. Blood samples are collected at multiple time points to study how the drug behaves in the body. Safety is assessed through physical exams, vital signs, lab tests, electrocardiograms, and monitoring for side effects. The study lasts through dosing and follow-up periods, with detailed evaluation of drug levels and tolerability up to 20 days after dosing.
CONDITIONS
Brief 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...
- Subjects voluntarily participate and sign informed consent
- Age between 18 and 50 years
- Body Mass Index (BMI) between 19.0 and 30.0 kg/m2
- Female subjects weigh between 45.0 and 120.0 kg; male subjects weigh between 50.0 and 120.0 kg
- Subjects and partners agree to use effective contraception from 1 month before screening to 6 months after last dose
You will not qualify if you...
- Known allergy to Tecovirimat drugs or ingredients or allergic to 2 or more substances
- Clinically significant abnormal ECG or QTc prolongation (QTc ≥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 of major diseases including cardiovascular, respiratory, digestive, urinary, endocrine, immune, or nervous system disorders
- Current or recent (past 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 during study until 1 month after end
- Blood donation or major blood loss (>450 mL) within 3 months before screening
- Smoking more than 5 cigarettes daily within 3 months before consent or inability to abstain during trial
- Consuming more than 14 alcohol units per week within 3 months before consent or inability to abstain during trial
- Consumption of grapefruit, chocolate, caffeine, or alcohol-containing beverages within 72 hours before dosing or refusal to abstain during trial
- Planned strenuous exercise including contact or collision sports during trial
- Positive urine drug screen or history of drug abuse within 5 years
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis antibodies
- 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
- Intolerance to venipuncture or history of fear of needles or blood
- Acute illness or need for medication from screening to dosing
- Vaccination within 2 weeks before screening or planned vaccination during trial
- Investigator deems subject unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 days per dose group
Participants receive a single dose of BSY001 or placebo in one of five ascending dose groups. Pharmacokinetic blood samples and safety assessments are collected. Tolerability is assessed on Day 4 for each dose group before the next dose group begins.
Multiple visits including Day 1 dosing and follow-ups on Days 4 and 10
Duration - 14 days
Participants receive 200 mg of BSY001 or placebo every 12 hours for 14 consecutive days under centralized management with scheduled blood sample collection and safety assessments.
Daily visits during hospitalization for dosing and assessments
Duration - Up to 10 days after dosing for single-dose cohorts; up to 6 days after dosing for multiple-dose cohort
Participants are monitored for safety and tolerability after completion of dosing, including laboratory tests, physical exams, and vital signs assessments.
Follow-up visits on Days 10 and 20 as applicable
Trial Site Locations
Total: 1 location
1
Shulan (Hangzhou) Hospital
Hangzhou, China
Actively Recruiting
Research Team
W
Wei Wang
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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