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The Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Genakumab for Injection in Chinese Healthy Volunteers
To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for Injection in Chinese healthy adult volunteers
Details
| Lead sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 40 |
| Start date | 2019-04-22 |
| Completion | 2020-09 |
Conditions
- Juvenile Idiopathic Arthritis
Interventions
- Genakumab
- Placebo for this trial
Primary outcomes
- Maximum observed serum Genakumab concentration — Baseline, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113 after administration
- Area under the serum Genakumab concentration-time curve — Baseline, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113 after administration
- Measurement of the serum IL-1β for pharmacodynamics study — Baseline, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113 after administration
Countries
China