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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A Solrikitug | Experimental |
| |
| Cohort B Solrikitug | Experimental |
| |
| Cohort C Solrikitug | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solrikitug | Biological | Solrikitug Formulation 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Treatment-Emergent Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE) V4.0 | 165 days |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentration of solrikitug | Pharmacokinetics (PK) of solrikitug in healthy participants | 112 days |
| Concentration of Immunogenicity | Immunogenicity profile of solrikitug in healthy participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Lee, MD | Uniquity One | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Brisbane | Queensland | Australia |
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| Solrikitug |
| Biological |
Solrikitug Formulation 2 |
|
| 112 days |