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Active, not recruitingNCT07390747Updated May 29, 2026

A Trial of SHR-2173 in Healthy Volunteers

A Phase 1 interventional study of SHR-2173 Injection/SHR-2173 placebo in Immunology, sponsored by Atridia Pty Ltd.. Active, not recruiting at 1 site in Australia. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-29.

Sponsored by Atridia Pty Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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

02

Conditions studied

  • Immunology
03

In context

Lead sponsor

Atridia Pty Ltd. is the lead sponsor of 34 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    SHR-2173 single dose

    Single dose of SHR-2173/ given subcutaneously

    Drug: SHR-2173 Injection/SHR-2173 placebo

  • Experimental
    SHR-2173 placebo single dose

    Single dose of SHR-2173/placebo given subcutaneously

    Drug: SHR-2173 Injection/SHR-2173 placebo

Interventions

  • DrugSHR-2173 Injection/SHR-2173 placebo

    Single dose SHR-2173 injection or matching placebo given subcutaneously

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics - Cmax

    Maximum observed plasma concentration (Cmax)

    Time frame: Day 71

  2. Pharmacokinetics - AUC₀-t

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

    Time frame: Day 71

  3. Pharmacokinetics - AUC₀-inf

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

    Time frame: Day 71

  4. Pharmacokinetics - Tmax

    Time to reach maximum observed plasma concentration (Tmax)

    Time frame: Day 71

  5. Pharmacokinetics - t½

    Terminal elimination half-life (t½)

    Time frame: Day 71

  6. Immunogenicity - Anti-Drug Antibody (ADA)

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

    Time frame: Day 71

Secondary outcomes

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

    Number of participants with Adverse events and Serious adverse events

    Time frame: Day 71

07

Study locations

1 site
  • Veritus Research
    Melbourne, Victoria, Australia
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07390747
Lead sponsor
Atridia Pty Ltd.
Responsible party
Sponsor
First posted
Feb 5, 2026
Start date
Mar 6, 2026
Primary completion
May 22, 2026
Completion
Aug 30, 2026 (estimated)
Last update
May 29, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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