Status:
COMPLETED
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ziresovir in Healthy Subjects
Lead Sponsor:
Shanghai Ark Biopharmaceutical Co., Ltd.
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 admini...
Detailed Description
Up to 3 dose cohorts are planned. The ziresovir dose level of each cohort is determined based on the collective clinical and nonclinical data of ziresovir. The proposed dose levels of Cohorts 1, 2 an...
Eligibility Criteria
Inclusion
- Capable of giving written informed consent and complying with study procedures;
- Between the ages of 18 and 55 years, inclusive;
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive and body weight not less than 50 kg;
- Female subjects must have a negative pregnancy test result at screening;
- Considered healthy by the Investigator, based on subject's reported medical history, full physical examination, 12-lead ECG, and vital signs;
- Willing and being able to adhere to study restrictions and to be confined at the Clinical Research Unit.
Exclusion
- Clinically significant reported history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator;
- Poor venous access;
- Taken an investigational drug or participated in a clinical trial evaluating an investigational drug or device within 30 days (or 5 half-lives) prior to the study drug dose, whichever is longer;
- Taken any prescription medications within 14 days or 5 half-lives (whichever is longer) of the study drug dose;
- Major surgery or hospitalization within 6 months prior to screening that in the Investigator's opinion would put the subject or study conduct at risk, or have any scheduled surgery or hospitalization during the study period;
- Any condition or finding that in the Investigator's opinion would put the subject or study conduct at risk if the subject were to participate in the study.
Key Trial Info
Start Date :
March 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04788017
Start Date
March 24 2021
End Date
July 22 2021
Last Update
February 15 2022
Active Locations (1)
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1
Frontage
Secaucus, New Jersey, United States, 07094