A Trial of SHR-2173 in Healthy Volunteers

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Immunology
• Intervention / Treatment: Drug: SHR-2173 Injection/SHR-2173 placebo

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia
      • Veritus Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-2173 single dose; Single dose of SHR-2173/ given subcutaneously	Drug: SHR-2173 Injection/SHR-2173 placebo; Single dose SHR-2173 injection or matching placebo given subcutaneously
Experimental: SHR-2173 placebo single dose; Single dose of SHR-2173/placebo given subcutaneously	Drug: SHR-2173 Injection/SHR-2173 placebo; Single dose SHR-2173 injection or matching placebo given subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events	Number of participants with Adverse events and Serious adverse events	Day 71

Collaborators and Investigators

• Sponsor: Atridia Pty Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2026
• Primary Completion (Actual): May 22, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SHR-2173-106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No