NCT05628116View on ClinicalTrials.gov

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.

PHASE1CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

September 28, 2022

Primary Completion Date

September 21, 2023

Study Completion Date

September 21, 2023

Conditions
Healthy Volunteers
Interventions
DRUG

XC243 50 mg single

The volunteers will receive a single dose of the ID (1 tablet once, 50 mg)

DRUG

XC243 100 mg single

The volunteers will receive a single dose of the ID (2 tablets once, 100 mg)

DRUG

Placebo single

The volunteers will receive a single dose of the ID (1 or 2 tablets once)

DRUG

XC243 200 mg single-dose food effect

The volunteers will receive single dose of the ID during first on an empty stomach, and after the washing period after eating (4 tablets, 200 mg)

DRUG

Placebo single-dose food effect

The volunteers will receive single dose of the ID during first on an empty stomach, and after the washing period after eating (4 tablets)

DRUG

XC243 200 mg multiple

The volunteers will receive multiple doses of the ID during 14 days (4 tablets daily, 200 mg each)

DRUG

Placebo multiple

The volunteers will receive multiple doses of the ID during 14 days (4 tablets daily)

Trial Locations (1)

194156

LLS X7 Clinical Research, Saint Petersburg

All Listed Sponsors
lead

PHARMENTERPRISES LLC

INDUSTRY