Study to Assess Safety, Tolerability and Pharmacokinetics of XC7 (Which is Planned Use in the Treatment of COVID-19) in Healthy Volunteers
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- COVID-19
- Healthy Volunteers
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: The dose cohorts cohorts will be included into the study subsequently based on preliminary safety results evaluation performed by the DSMC. 2 doses of XC7/placebo (100 mg, 200 mg) were used in the study.The duration of exposure to the ID is planned 1 day in single dosing cohorts and 14 days in multiple dosing cohort.Masking: Double (Participant, Investigator)Masking Description: Blinding was carried out by using placebo equivalent to XC7 capsules without active pharmaceutical ingredients (API) and the corresponding labeling of the ID.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 45 years
- Gender
- Only males
Description
The study will be conducted in 1 centre. The study will consist of 3 periods: screening (7 days), treatment (1 or 14 days) and follow-up (7 or 28 days). The volunteers of single dosing cohorts will receive the investigated drug (ID) ??7 or placebo once and stay at the study center for at least 24 ho...
The study will be conducted in 1 centre. The study will consist of 3 periods: screening (7 days), treatment (1 or 14 days) and follow-up (7 or 28 days). The volunteers of single dosing cohorts will receive the investigated drug (ID) ??7 or placebo once and stay at the study center for at least 24 hours after the ID administration to monitor the safety parameters and for sampling for PK analysis. The Follow-up will last 7 days, during which safety parameters and PK in volunteers will be studied. Based on all safety data from the XC7 100 mg cohort, the Data Safety Monitoring Committee (DSMC) will consider dose increase and entry of the 200 mg cohort. If the single dose of ??7 200 mg is considered to be safe, the third multiple dosing cohort of 200 mg will be included in the study. The volunteers from multiple dosing cohort will receive the ID (??7 or placebo) once a day during 14 days and will stay at the hospital (study center) during the first five days after administration of the ID. The Follow-up will last 14 days, during which they will study safety parameters and PK in volunteers.
Tracking Information
- NCT #
- NCT04679493
- Collaborators
- Not Provided
- Investigators
- Not Provided
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