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NCT Number: NCT07390747

A Trial of SHR-2173 in Healthy Volunteers

The purpose of this study is to assess safety, PK, Pharmacodynamic and immunogenicity profile of a single dose of SHR-2173 in healthy participants

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Veritus Research

Melbourne, Victoria, Australia

Who can participate

Healthy volunteers accepted: Yes

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

Main inclusion criteria

  • Healthy white participants.
  • 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.
  • Male aged between 18 to 45 years of age (inclusive)
  • 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 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.
  • The injection site has abnormalities or is deemed by the investigator as unsuitable for subcutaneous injection.
  • 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

SHR-2173 Injection/SHR-2173 placebo

Drug

Single dose SHR-2173 injection or matching placebo given subcutaneously

Primary outcomes

  1. Pharmacokinetics - Cmax

    Time frame: Day 71

    Maximum observed plasma concentration (Cmax)

  2. Pharmacokinetics - AUC₀-t

    Time frame: Day 71

    Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC₀-t)

  3. Pharmacokinetics - AUC₀-inf

    Time frame: Day 71

    Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC₀-inf)

  4. Pharmacokinetics - Tmax

    Time frame: Day 71

    Time to reach maximum observed plasma concentration (Tmax)

  5. Pharmacokinetics - t½

    Time frame: Day 71

    Terminal elimination half-life (t½)

  6. Immunogenicity - Anti-Drug Antibody (ADA)

    Time frame: Day 71

    Incidence and onset time of anti-drug antibody (ADA)

Secondary outcomes

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

    Time frame: Day 71

    Number of participants with Adverse events and Serious adverse events

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 Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Single Subcutaneous Administration of SHR-2173 in Healthy Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2026
Registry last updated
May 29, 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.

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