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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06868082




Registration number
NCT06868082
Ethics application status
Date submitted
26/02/2025
Date registered
25/03/2025

Titles & IDs
Public title
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Solrikitug in Healthy Japanese and Non-Japanese Participants
Scientific title
A Phase 1, Open-Label Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Formulations of Subcutaneously Administered Solrikitug in Healthy Japanese and Non-Japanese Participants
Secondary ID [1] 0 0
NSI-8226-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Solrikitug
Treatment: Other - Solrikitug

Experimental: Cohort A Solrikitug -

Experimental: Cohort B Solrikitug -

Experimental: Cohort C Solrikitug -


Treatment: Other: Solrikitug
Solrikitug Formulation 1

Treatment: Other: Solrikitug
Solrikitug Formulation 2
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events
Timepoint [1] 0 0
165 days
Secondary outcome [1] 0 0
Serum concentration of solrikitug
Timepoint [1] 0 0
112 days
Secondary outcome [2] 0 0
Concentration of Immunogenicity
Timepoint [2] 0 0
112 days

Eligibility
Key inclusion criteria
* At the time of initial screening, in general good health (age 18 to 55 years);
* Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring
* Participant must agree to use contraception during the treatment period and until follow-up
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions of the study
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Pregnancy or breastfeeding during the study
* Chronic infection
* Treatment with prohibited medications.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Research Site - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Uniquity One (UNI)
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Andrew Lee, MD
Address 0 0
Uniquity One
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Uniquity One
Address 0 0
Country 0 0
Phone 0 0
484-267-2500
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT06868082