drugset / Trial / NCT05099133
A Trial to Evaluate Pharmacokinetics, Immunogenicity, Safety, and Tolerability of LEO 138559 in Healthy Japanese Subjects
RandomizedParallel-groupDouble-blindTreatment
Summary
This trial will investigate the pharmacokinetics, immunogenicity, safety, and tolerability of LEO 138559 in healthy Japanese subjects. The trial consists of a screening period of up to 4 weeks, a single treatment with either LEO 138559 or placebo, and 8 follow-up visits to Day 85. A total of 24 healthy subjects will be enrolled in 3 dose groups (n=8 per dose group) and randomized to either LEO 138559 or placebo in a ratio of 6:2.
Timeline
- Start
- 2021-11-03
- Primary completion
- 2022-06-28
- Completion
- 2022-06-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TEMTOKIBART | Protein / enzyme biologic | — | Subcutaneous |