NCT07078695

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
5mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Aug 2025Sep 2026

First Submitted

Initial submission to the registry

July 13, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
28 days until next milestone

Study Start

First participant enrolled

August 19, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

July 13, 2025

Last Update Submit

March 17, 2026

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (5)

  • PK profile of SHR-1139 after a single administration

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

    Start of Treatment to end of study (Day 253)

  • PK profile of SHR-1139 after a single administration

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

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

  • PK profile of SHR-1139 after a single administration:

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

    Start of Treatment to end of study (Day 253)

  • PK profile of SHR-1139 after a single administration

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

    Start of Treatment to end of study (Day 253)

  • Immunogenicity profile of SHR-1139 after a single dose administration

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

    Day 253

Secondary Outcomes (1)

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

    Day 295

Study Arms (3)

SHR-1139 dose level 1

EXPERIMENTAL

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

Drug: SHR-1139 Injection

SHR-1139 dose level 2

EXPERIMENTAL

Single dose of SHR-1139 given subcutaneously (dose level 2)

Drug: SHR-1139 Injection

SHR-1139 dose level 3

EXPERIMENTAL

Single dose of SHR-1139 given intravenously (dose level 3)

Drug: SHR-1139 Injection

Interventions

SHR-1139 InjectionDRUG

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

SHR-1139 dose level 1

Eligibility Criteria

Age18 Years - 55 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (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 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

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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linear

Perth, Western Australia, Australia

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2025

First Posted

July 22, 2025

Study Start

August 19, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)