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Active, Not Recruiting

NCT Number: NCT07078695

A Trial of SHR-1139 in Healthy Volunteers

The purpose of this study is to assess safety, PK and immunogenicity profile of a single dose of SHR-1139 in healthy volunteers

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Linear

Perth, Western Australia, Australia

Who can participate

Healthy volunteers accepted: Yes

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

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 55 years of age (inclusive)
  • Women with body weight ≥ 45.0 kg, men with body weight ≥ 50.0 kg, body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening.
  • Men and WOCBP must agree to take highly effective contraceptive methods

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 drug or any component of it.
  • Receipt of medical devices or another investigational drug (including placebo) within 3 months or 5 half-lives, or in the follow-up period of a clinical study, whichever is longer (according to the date of the signed consent form) prior to screening.
  • Unwilling or unable to comply with the Lifestyle Guidelines detailed in this protocol.
  • Positive pregnancy test at screening or D-1/check-in.
  • 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-1139 Injection

Drug

Single dose of SHR-1139 given subcutaneously (dose level 1 )

Primary outcomes

  1. PK profile of SHR-1139 after a single administration

    Time frame: Start of Treatment to end of study (Day 253)

    Pharmacokinetics- Area under the concentration-time curve from time 0 to last time point after SHR-1139 administration (AUC0-last)

  2. PK profile of SHR-1139 after a single administration

    Time frame: From time 0 to infinity after SHR-1139 administration (Day 253)

    Pharmacokinetics- Area under the concentration-time curve (AUC0-inf)

  3. PK profile of SHR-1139 after a single administration:

    Time frame: Start of Treatment to end of study (Day 253)

    Pharmacokinetics- Time to Cmax of SHR-1139 (Tmax )

  4. PK profile of SHR-1139 after a single administration

    Time frame: Start of Treatment to end of study (Day 253)

    Pharmacokinetics-Terminal elimination half-life of SHR-1139 (t1/2)

  5. Immunogenicity profile of SHR-1139 after a single dose administration

    Time frame: Day 253

    The number of participants with anti-drug antibody (ADA)

Secondary outcomes

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

    Time frame: Day 295

    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, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Subcutaneous/Intravenous Administered SHR-1139 in Healthy Participants

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2025
Registry last updated
Mar 19, 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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