Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Ascending Doses of XC243 After Single and Multiple Oral Administration in Healthy Volunteers.

Summary

A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety, tolerability and pharmacokinetics (PK) of ascending doses of XC243 after single and multiple oral administration in healthy volunteers. It's planned to include sequentially 2 cohorts of 7 volunteers who will receive a single dose of XC243 (50 mg and 100 mg) or placebo (cohort ratio 5:2), 1 cohort of 14 volunteers who will receive a single dose of XC243 200 mg or placebo first on an empty stomach, and after the washing period after eating (cohort ratio 12:2) and 1 cohort of 10 volunteers who will receive XC243 200 mg or placebo on an empty stomach during 14 days (cohort ratio 8:2).

Timeline

Start

2022-09-28

Primary completion

2023-09-21

Completion

2023-09-21

Drugs

Indications

No indication recorded.