NCT06868082

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jun 2025

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

June 20, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2026

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

February 26, 2025

Last Update Submit

February 6, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment-Emergent Adverse Events

    Treatment-Emergent Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE) V4.0

    165 days

Secondary Outcomes (2)

  • Serum concentration of solrikitug

    112 days

  • Concentration of Immunogenicity

    112 days

Study Arms (3)

Cohort A Solrikitug

EXPERIMENTAL
Biological: Solrikitug

Cohort B Solrikitug

EXPERIMENTAL
Biological: Solrikitug

Cohort C Solrikitug

EXPERIMENTAL
Biological: Solrikitug

Interventions

SolrikitugBIOLOGICAL

Solrikitug Formulation 1

Cohort A Solrikitug

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Brisbane, Queensland, Australia

Location

Study Officials

  • Andrew Lee, MD

    Uniquity One

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2025

First Posted

March 10, 2025

Study Start

June 20, 2025

Primary Completion

February 2, 2026

Study Completion

February 2, 2026

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

AU(1)