A Trial of HRS-3095 in Healthy Volunteers

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

The purpose of this study is to assess safety, PK, Pharmacodynamic profile of a single dose of HRS-3095 in healthy participants

Main inclusion criteria

1. Healthy white participants.
2. Male or female aged between 18 years and 55 years (inclusive)
3. 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.
4. 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.
5. Men and WOCBP must agree to take highly effective contraceptive methods

Main exclusion Criteria

1. History or evidence of clinically significant disorders.
2. Individuals with a history of drug allergies, specific allergies, or known history or suspected of being allergic to the study drug or same class drug or any component of it.
3. Receipt of medical devices or another investigational drug within 3 months or 5 half-lives, whichever is longer prior to screening.
4. History of excessive smoking in the past 1 month prior to screening
5. History of illicit or prescription drug abuse or addiction within 1 year of screening, or positive urine drug screen at baseline.
6. Any other circumstances (e.g., not suitable for venous access) or laboratory abnormality that, in the investigator's judgment, may increase the risk to the participant, or be associated with the participant's participation in and completion of the study or could preclude the evaluation of the participant's response.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply