A Phase 1, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of HRS-3095 in Healthy Participants
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY
The purpose of this study is to assess safety, PK, Pharmacodynamic profile of a single dose of HRS-3095 in healthy participants
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:
• Healthy white participants.
• Male or female aged between 18 years and 55 years (inclusive)
• Ability to understand the trial procedures and possible adverse events, volunteer to participate in the trial, and provide written informed consent, be able to comply with all the requirements, and able to complete the study.
• Women with body weight ≥ 45.0 kg, men with body weight ≥ 50.0 kg, body mass index (BMI) between 19.0 and 30.0 kg/m2 (inclusive) at screening.
• Men and WOCBP must agree to take highly effective contraceptive methods
Locations
Other Locations
Australia
Veritus Research
RECRUITING
Bayswater
Contact Information
Primary
Kathy You
kathyyou@atridia.com
+61 02 9299 0433
Backup
Eimy Minowa
eimy.minowa@atridia.com
+61 432223162
Time Frame
Start Date: 2026-07-27
Estimated Completion Date: 2026-10-15
Participants
Target number of participants: 36
Treatments
Experimental: HRS-3095 single dose Dose level 1
Single dose HRS-3095 /placebo given orally
Experimental: HRS-3095 single dose Dose level 2
Single dose HRS-3095 /placebo given orally
Experimental: HRS-3095 single dose Dose level 3
Single dose HRS-3095 /placebo given orally
Related Therapeutic Areas
Sponsors
Leads: Atridia Pty Ltd.