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A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ziresovir in Healthy Subjects

NCT04788017 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-02-15

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of ziresovir following a single ascending oral dose administration in healthy adult subjects under fasted conditions.

Conditions

  • Healthy Subjects

Interventions

DRUG

Ziresovir

Planned treatments are: * Cohort 1: 300 mg of ziresovir * Cohort 2: up to 600 mg of ziresovir * Cohort 3: up to 900 mg of ziresovir

OTHER

Placebo

Planned treatments are: * Cohort 1: 300 mg of placebo * Cohort 2: up to 600 mg of placebo * Cohort 3: up to 900 mg of placebo

Sponsors & Collaborators

  • Shanghai Ark Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jimmy Gu · Ark Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-24
Primary Completion
2021-06-14
Completion
2021-07-22
FDA Drug
Yes

Countries

  • United States

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 NCT04788017 on ClinicalTrials.gov