A Trial of HRS-3095 in Healthy Volunteers (NCT07686484) | Clinical Trial Compass
RecruitingEarly Phase 1
A Trial of HRS-3095 in Healthy Volunteers
Australia36 participantsStarted 2026-07-27
Plain-language summary
The purpose of this study is to assess safety, PK, Pharmacodynamic profile of a single dose of HRS-3095 in healthy participants
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events
. 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.