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Phase I Study of JY1001 Injection
Sponsor: Jemincare
Summary
The goal of this dose esclation study is to evaluate the safety, tolerability, and PK characteristicsafter of a single dose of JY1001 injection in healthy participants. A total of 6 cohorts are planned to be evaluated. Each cohort will enroll 8 participants to receive JY1001 or placebo in 3:1 ratio.
Official title: A Randomized, Double-blind, Placebo-controlled, Dose Escalation Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Character of a Single Dose of JY1001 Injection in Healthy Adult Participants
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2026-11
Completion Date
2027-05
Last Updated
2026-09-30
Healthy Volunteers
Yes
Conditions
Interventions
JY1001
Participants will receive a single dose of JY1001 (10 mg, 20 mg, 40 mg, 80 mg, 160 mg, 320 mg) via IV at Day 1
Placebo
Participants will receive a single dose of placebo via IV at Day 1
Locations (1)
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, China