Healthy
Conditions
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
Interventions
BIOLOGICALSolrikitug
Solrikitug Formulation 1
Sponsors
Uniquity One (UNI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 165 days | Treatment-Emergent Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE) V4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum concentration of solrikitug | 112 days | Pharmacokinetics (PK) of solrikitug in healthy participants |
| Concentration of Immunogenicity | 112 days | Immunogenicity profile of solrikitug in healthy participants |
Countries
Australia
Contacts
STUDY_CHAIRAndrew Lee, MD
Uniquity One
Outcome results
None listed