A Trial of SHR-2173 in Healthy Volunteers

NCT07390747 | Recruiting Phase 1

• 1 other identifier: SHR-2173-106
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Immunology

Outcome Measures

Primary Outcomes (6)

• Pharmacokinetics - Cmax

  Maximum observed plasma concentration (Cmax)

  Day 71

• Pharmacokinetics - AUC₀-t

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

  Day 71

• Pharmacokinetics - AUC₀-inf

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

  Day 71

• Pharmacokinetics - Tmax

  Time to reach maximum observed plasma concentration (Tmax)

  Day 71

• Pharmacokinetics - t½

  Terminal elimination half-life (t½)

  Day 71

• Immunogenicity - Anti-Drug Antibody (ADA)

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

  Day 71

Secondary Outcomes (1)

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

  Day 71

Study Arms (2)

SHR-2173 single dose

EXPERIMENTAL

Single dose of SHR-2173/ given subcutaneously

Drug: SHR-2173 Injection/SHR-2173 placebo

SHR-2173 placebo single dose

EXPERIMENTAL

Single dose of SHR-2173/placebo given subcutaneously

Drug: SHR-2173 Injection/SHR-2173 placebo

Interventions

SHR-2173 Injection/SHR-2173 placebo DRUG

Single dose SHR-2173 injection or matching placebo given subcutaneously

SHR-2173 placebo single dose; SHR-2173 single dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atridia Pty Ltd.: lead

Study Sites (1)

Veritus Research

Melbourne, Victoria, Australia

RECRUITING

Central Study Contacts

Kathy You

CONTACT

+61 02 9299 0433; kathyyou@atridia.com

Eimy Minowa

CONTACT

61 432223162; eimy.minowa@atridia.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single dose of SHR-2173 will be administered subcutaneously

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: March 6, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-01

Locations

AU (1)