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

February 6, 2026 updated by: Uniquity One (UNI)

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A Solrikitug
Biological: Solrikitug
Solrikitug Formulation 1
Biological: Solrikitug
Solrikitug Formulation 2
Experimental: Cohort B Solrikitug
Biological: Solrikitug
Solrikitug Formulation 1
Biological: Solrikitug
Solrikitug Formulation 2
Experimental: Cohort C Solrikitug
Biological: Solrikitug
Solrikitug Formulation 1
Biological: Solrikitug
Solrikitug Formulation 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: 165 days
Treatment-Emergent Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE) V4.0
165 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum concentration of solrikitug
Time Frame: 112 days
Pharmacokinetics (PK) of solrikitug in healthy participants
112 days
Concentration of Immunogenicity
Time Frame: 112 days
Immunogenicity profile of solrikitug in healthy participants
112 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uniquity One (UNI)

Investigators

  • Study Chair: Andrew Lee, MD, Uniquity One

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2025

Primary Completion (Actual)

February 2, 2026

Study Completion (Actual)

February 2, 2026

Study Registration Dates

First Submitted

February 26, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 10, 2025

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • NSI-8226-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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