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Study to Assess Safety, Tolerability and Pharmacokinetics of XC7 (Which is Planned Use in the Treatment of COVID-19) in Healthy Volunteers

NCT04679493 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-09-22

No results posted yet for this study

Summary

A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety, tolerability and pharmacokinetics (PK) of ascending doses of XC7 after single and multiple oral administration in healthy volunteers. It's planned to include sequentially 2 cohorts of 4 volunteers who will receive a single dose of XC7 (100 mg and 200 mg) or placebo (cohort ratio 3:1) and 1 cohort of 8 volunteers who will receive multiple doses of the XC7 (200 mg) or placebo during 14 days (cohort ratio 6:2).

Conditions

  • Covid19
  • Healthy Volunteers

Interventions

DRUG

XC7 100 mg single

The volunteers will receive a single dose of the ID (1 capsule once, 100 mg)

DRUG

XC7 200 mg single

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

DRUG

Placebo single

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

DRUG

XC7 200 mg multiple

The volunteers will receive multiple doses of the ID during 14 days (2 capsules daily, 100 mg each)

DRUG

Placebo multiple

The volunteers will receive multiple doses of the ID during 14 days (2 capsules daily)

Sponsors & Collaborators

  • NP Therapeutics

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-17
Primary Completion
2021-04-09
Completion
2021-04-09

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04679493 on ClinicalTrials.gov