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.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:
• Subjects voluntarily participate in the study, sign the informed consent form, and agree to comply with all study requirements;
• Aged ≥ 18 years and ≤ 50 years (based on the date of signing the informed consent form), including both males and females;
• Body Mass Index (BMI) between 19.0 and 30.0 kg/m² (19.0 and 30.0 kg/m² inclusive); for female subjects, body weight between 45.0 and 120.0 kg (45.0 kg inclusive and 120.0 kg exclusive); for male subjects, body weight between 50.0 and 120.0 kg (50.0 kg inclusive and 120.0 kg exclusive);
• Subjects (including their partners) voluntarily adopt effective contraceptive measures from 1 month before screening to 6 months after the last administration of the study drug, and have no plans for childbearing, sperm donation, or egg donation within the next 6 months.
Locations
Other Locations
China
Shulan (Hangzhou) Hospital
RECRUITING
Hangzhou
Contact Information
Primary
Wei Wang
nvsiclinicaltrials@163.com
+86-010-60963099
Time Frame
Start Date:2025-08-28
Estimated Completion Date:2026-02-13
Participants
Target number of participants:76
Treatments
Experimental: SAD Cohort 1
A single dose of 37.5mg BSY001 for injection or placebo administered, with 6 subjects receiving BSY001 for injection and 2 subjects receiving the placebo
Experimental: SAD Cohort 2
A single dose of 75 mg BSY001 for injection or placebo administered, with 6 subjects receiving BSY001 for injection and 2 subjects receiving the placebo
Experimental: SAD Cohort 3
A single dose of 150 mg BSY001 for injection or placebo administered, with 8 subjects receiving BSY001 for injection and 2 subjects receiving the placebo
Experimental: SAD Cohort 4
A single dose of 200 mg BSY001 for injection or placebo administered, with 8 subjects receiving BSY001 for injection and 2 subjects receiving the placebo
Experimental: SAD Cohort 5
A single dose of 300 mg BSY001 for injection or placebo administered, with 8 subjects receiving BSY001 for injection and 2 subjects receiving the placebo
Experimental: MAD Cohort
Administer 200 mg of BSY001 or placebo every 12 hours for 14 consecutive days. Among them, 24 subjects will receive BSY001 for injection, and the other 6 subjects will receive placebo.