At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Placebo-controlled, Randomised, First in Human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of C106 in Healthy Male and Female Subjects
In Brief
A Phase 1 clinical trial evaluating C106 solution and Placebo for Safety Issues and 3 related conditions. Completed, enrolled 80 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist
Placebo for C106 solution