drugset / Trial / NCT05099133

A Trial to Evaluate Pharmacokinetics, Immunogenicity, Safety, and Tolerability of LEO 138559 in Healthy Japanese Subjects

NCT05099133

Phase 1 Completed 24 enrolled LEO Pharma
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

EvaluationDrugModalityDoseRoute
Subject TEMTOKIBART Protein / enzyme biologic Subcutaneous

Indications