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OpenTrials
Completed

NCT Number: NCT06868082

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of 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

Completed

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Brisbane, Queensland, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Solrikitug

Biological

Solrikitug Formulation 1

Primary outcomes

  1. 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

Secondary outcomes

  1. Serum concentration of solrikitug

    Time frame: 112 days

    Pharmacokinetics (PK) of solrikitug in healthy participants

  2. Concentration of Immunogenicity

    Time frame: 112 days

    Immunogenicity profile of solrikitug in healthy participants

Sponsors and collaborators

Lead sponsor

Uniquity One (UNI)

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2025
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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