Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06067568 | Relative Bioavailability of Two Lutikizumab Formulations and Pharmacokinetics, Safety, and Tolerability of Lutikizumab in Chinese Participants | PHASE1 | COMPLETED | 50 | — | — | Sep 28, 2023 | Feb 26, 2024 | Mar 15, 2024 | 3 | United States |
Cmax of lutikizumab will be assessed.
Tmax of lutikizumab will be assessed.
Apparent terminal phase elimination rate constant (β) of lutikizumab will be assessed.
Terminal phase elimination half-life (t1/2) of lutikizumab will be assessed.
AUC0-t of lutikizumab will be assessed.
AUC0-inf of lutikizumab will be assessed.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| Part 1, Dose A | EXPERIMENTAL | Participants will receive a single dose of Lutikizumab Dose A. |
| Part 1, Dose B | EXPERIMENTAL | Participants will receive a single dose of Lutikizumab Dose B. |
| Part 2 | EXPERIMENTAL | Han Chinese participants will receive a single dose of Lutikizumab. |
| Name | Type | Description |
|---|---|---|
| Lutikizumab Dose A | DRUG | Injection; subcutaneous (SC) |
| Lutikizumab Dose B | DRUG | Injection; subcutaneous (SC) |
Inclusion Criteria: * Male and female healthy volunteers aged between 18 and 60 years. \-- Part 2 only: Participant must be first-generation Han Chinese of full Chinese parentage residing outside of China. Participant must maintain a typical Chinese lifestyle, including consuming a typical Chine...