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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07078695




Registration number
NCT07078695
Ethics application status
Date submitted
13/07/2025
Date registered
22/07/2025
Date last updated
12/09/2025

Titles & IDs
Public title
A Trial of SHR-1139 in Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
SHR-1139-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SHR-1139 Injection
Treatment: Drugs - SHR-1139 Injection
Treatment: Drugs - SHR-1139 Injection

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

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

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


Treatment: Drugs: SHR-1139 Injection
Single dose of SHR-1139 given subcutaneously (dose level 1 )

Treatment: Drugs: SHR-1139 Injection
Single dose of SHR-1139 given subcutaneously (dose level 2 )

Treatment: Drugs: SHR-1139 Injection
Single dose of SHR-1139 given intravenously (dose level 3)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PK profile of SHR-1139 after a single administration
Timepoint [1] 0 0
Start of Treatment to end of study (Day 253)
Primary outcome [2] 0 0
PK profile of SHR-1139 after a single administration
Timepoint [2] 0 0
From time 0 to infinity after SHR-1139 administration (Day 253)
Primary outcome [3] 0 0
PK profile of SHR-1139 after a single administration:
Timepoint [3] 0 0
Start of Treatment to end of study (Day 253)
Primary outcome [4] 0 0
PK profile of SHR-1139 after a single administration
Timepoint [4] 0 0
Start of Treatment to end of study (Day 253)
Primary outcome [5] 0 0
Immunogenicity profile of SHR-1139 after a single dose administration
Timepoint [5] 0 0
Day 253
Secondary outcome [1] 0 0
Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events
Timepoint [1] 0 0
Day 295

Eligibility
Key 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 55 years of age (inclusive)
4. 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.
5. Men and WOCBP must agree to take highly effective contraceptive methods
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 drug or any component of it.
3. 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.
4. Unwilling or unable to comply with the Lifestyle Guidelines detailed in this protocol.
5. Positive pregnancy test at screening or D-1/check-in.
6. 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/08/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear - Perth
Recruitment postcode(s) [1] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Atridia Pty Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kathy You
Address 0 0
Country 0 0
Phone 0 0
+61 02 9299 0433
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07078695