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

Uniquity One (UNI)

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Biological: Solrikitug

Study type: Interventional

Funder types: Industry

Identifiers

NCT06868082

NSI-8226-102

Details and patient eligibility

About

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

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 3 patient groups

Cohort A Solrikitug

Experimental group

Treatment:

Biological: Solrikitug

Biological: Solrikitug

Cohort B Solrikitug

Experimental group

Treatment:

Biological: Solrikitug

Biological: Solrikitug

Cohort C Solrikitug

Experimental group

Treatment:

Biological: Solrikitug

Biological: Solrikitug