A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Studyto Evaluate the Safety, Tolerability and Pharmacokinetics of HS-10390 in Healthy Subjects
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The purpose of this first in human study is to evaluate the safety, tolerability, pharmacokinetics (PK),and pharmacodynamics (PD) of HS-10390 in healthy subjects.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:
• Healthy male or female subjects between the ages of 18-45 years
• Have no reproductive potential; or agree to use a highly effective method ofcontraception, and refrain from donating sperm or eggs during the study period and forat least 6 months after last dosing
• Have signed the informed consent form approved by the IRB
Locations
Other Locations
China
Zhongda Hospital, Affiliated to Southeast University
RECRUITING
Nanjing
Contact Information
Primary
Bicheng Liu
liubc64@163.com
18001580838
Time Frame
Start Date: 2023-05-23
Estimated Completion Date: 2024-12-30
Participants
Target number of participants: 84
Treatments
Experimental: HS-10390
Single or multiple dosing of HS-10390 in a fastingstate
Experimental: Placebo
Single or multiple dosing of placebo in a fastingstate
Related Therapeutic Areas
Sponsors
Leads: Hansoh BioMedical R&D Company