A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Solrikitug in Healthy Japanese and Non-Japanese Participants

Phase 1

Not yet recruiting

• Conditions: Healthy
• Interventions: Biological: Solrikitug

• Registration Number: NCT06868082
• Lead Sponsor: Uniquity One (UNI)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-26
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Study Start: 2025-05-30
• Primary Completion: 2025-08-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

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

Exclusion Criteria

• Pregnancy or breastfeeding during the study
• Chronic infection
• Treatment with prohibited medications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort A Solrikitug	Solrikitug	-
Cohort B Solrikitug	Solrikitug	-
Cohort C Solrikitug	Solrikitug	-

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	165 days	Treatment-Emergent Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE) V4.0

Secondary Outcome Measures

Name	Time	Method
Serum concentration of solrikitug	112 days	Pharmacokinetics (PK) of solrikitug in healthy participants
Concentration of Immunogenicity	112 days	Immunogenicity profile of solrikitug in healthy participants

Trial Locations

Locations (1)

Research Site; 🇦🇺 Brisbane, Queensland, Australia