First-in-human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of C106 in Healthy Subjects

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.

Timeline

Start

2022-06-08

Primary completion

2023-06-22

Completion

2023-06-22

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

release “The Phase 1 study of C106 has concluded and that Vicore will not continue further development due to a transient increase in blood pressure observed” vicorepharma.com ↗

Drugs

Indications