Single-dose SHR-2173 in healthy adults

A Phase 1, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Single Subcutaneous Administration of SHR-2173 in Healthy Participants

This will test a single injection of SHR-2173 in healthy adult volunteers to see if it is safe and how the body handles and responds to it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Atridia Pty Ltd. (Industry-sponsored)
• Locations: 1 site (Melbourne, Victoria)
• Trial ID: NCT07390747 on ClinicalTrials.gov

What this trial studies

This Phase 1, single-dose study enrolls healthy adult participants to receive either SHR-2173 or placebo and undergo close monitoring. Participants will have blood draws and clinical checks to measure safety, pharmacokinetics, pharmacodynamic markers, and any immune response to the drug. The protocol specifies enrollment of healthy white adults aged 18–45 with defined weight and BMI limits and contraceptive requirements for men and women of childbearing potential. The study is conducted at a single research center in Melbourne, Victoria under the sponsorship of Atridia Pty Ltd.

Who should consider this trial

Good fit: Healthy adults (per the protocol primarily white) aged 18–45 with BMI 19–30 kg/m2, meeting the trial's weight and contraceptive requirements and without significant medical history are the intended participants.

Not a fit: People with active medical conditions, a history of relevant drug or component allergies, recent participation in other investigational drug studies, or injection-site abnormalities are excluded and would not benefit from participating.

Why it matters

Potential benefit: If successful, the study could identify a safe single dose and early PK/PD and immunogenicity data to guide further development for immunology treatments.

How similar studies have performed: Single-dose Phase 1 safety and PK studies are a common first step for immunology drugs and have supported development of other agents, but SHR-2173 itself is being tested in humans at this early stage.

Eligibility criteria

Main inclusion criteria

1. Healthy white participants.
2. 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.
3. Male aged between 18 to 45 years of age (inclusive)
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 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. The injection site has abnormalities or is deemed by the investigator as unsuitable for subcutaneous injection.
5. History of excessive smoking in the past 1 month prior to screening
6. History of illicit or prescription drug abuse or addiction within 1 year of screening, or positive urine drug screen at baseline.
7. 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

Where this trial is running

Melbourne, Victoria

• Veritus Research — Melbourne, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: Kathy You

Conditions Immunology