First-in-human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of C106 in Healthy Subjects
Status:
Recruiting
Trial end date:
2022-12-17
Target enrollment:
Participant gender:
Summary
This is a FIH, double-blind, placebo-controlled, within-group randomised, trial designed to
evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending
oral doses of compound 106 (C106) in healthy females of non-childbearing potential and
healthy males.
The trial will be conducted in 2 parts:
Part A, single ascending dose (SAD) including a food interaction cohort: safety,
tolerability, and PK in healthy males and healthy females of non-childbearing potential
receiving single ascending doses of C106.
Part B, multiple ascending dose (MAD): safety, tolerability, and PK in healthy males and
healthy females of non-childbearing potential receiving twice daily multiple ascending doses
of C106 for 8 days.