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

NCT ID: NCT06868082

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-20

Study Completion Date

2026-01-27

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort A Solrikitug

Group Type EXPERIMENTAL

Solrikitug

Intervention Type BIOLOGICAL

Solrikitug Formulation 1

Cohort B Solrikitug

Group Type EXPERIMENTAL

Solrikitug

Intervention Type BIOLOGICAL

Solrikitug Formulation 2

Cohort C Solrikitug

Group Type EXPERIMENTAL

Solrikitug

Intervention Type BIOLOGICAL

Solrikitug Formulation 2

Interventions

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Solrikitug

Solrikitug Formulation 1

Intervention Type BIOLOGICAL

Solrikitug

Solrikitug Formulation 2

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Uniquity One (UNI)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Lee, MD

Role: STUDY_CHAIR

Uniquity One

Locations

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Research Site

Brisbane, Queensland, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Uniquity One

Role: CONTACT

484-267-2500

Facility Contacts

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Michael Wong, MD

Role: primary

Other Identifiers

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NSI-8226-102

Identifier Type: -

Identifier Source: org_study_id

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