Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07686484

A Trial of HRS-3095 in Healthy Volunteers

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Main inclusion criteria

  • 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

Main exclusion Criteria

  • History or evidence of clinically significant disorders.
  • 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.
  • Receipt of medical devices or another investigational drug within 3 months or 5 half-lives, whichever is longer prior to screening.
  • History of excessive smoking in the past 1 month prior to screening
  • History of illicit or prescription drug abuse or addiction within 1 year of screening, or positive urine drug screen at baseline.
  • 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

Treatment and study plan

HRS-3095

Drug

Single dose HRS-3095 /placebo given orally - Dose level 1

Primary outcomes

  1. Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events

    Time frame: Day 8

    Number of participants with Adverse events and Serious adverse events

Secondary outcomes

  1. PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - Cmax

    Time frame: Day 4

    Maximum observed plasma concentration (Cmax)

  2. PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - AU0-inf

    Time frame: Day 4

    Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC₀0-inf)

  3. PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - Tmax

    Time frame: Day 4

    Time to reach maximum observed plasma concentration (Tmax)

  4. PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - t½

    Time frame: Day 4

    Terminal elimination half-life (t1/2)

  5. PD Profile of HRS-3095 After a Single dose administration:

    Time frame: Day 8

    Target occupancy assessment

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Atridia Pty Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.