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Evaluate the Pharmacokinetics of BAT2022 in Healthy Chinese Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Evaluate the Pharmacokinetics of BAT2022 in Healthy Chinese Subjects

A Randomized, Double-Blind, Phase I Clinical Study to Evaluate the Pharmacokinetics of BAT2022 in Healthy Chinese Subjects

NCT05518695•Bio-Thera Solutions

View on ClinicalTrials.gov

Summary

To evaluate the safety and tolerability of BAT2022 in healthy subjects.

Detailed Description

This is a single-center, randomized, double-blind, placebo-controlled, dose-escalation clinical study to evaluate the pharmacokinetics, safety, tolerability, immunogenicity and pharmacodynamics of BAT2022 for Injection in healthy subjects.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects who have signed the informed consent form prior to the study and have a full understanding of the content, process and possible adverse reactions;
•2. Subjects who are willing and able to follow the visit and treatment specified in this study;
•3. Subject (including partner) who is willing to have no pregnancy plan or sperm donation plan within the following 6 months (i.e., within 6 months after administration of the investigational product) and voluntarily take effective contraceptive measures;
•4. Healthy male or female subjects aged 18 \~ 55 years (inclusive);
•5. Subjects with body weight of 50 kg \~ 100 kg (inclusive);
•6. Subjects with normal or abnormal physical examination without clinical significance;

Exclusion Criteria

•1. Subjects who have smoked more than 5 cigarettes per day three months prior to Screening;
•2. Any subject with a current or past serious allergic reaction to food or drug, or serious allergic or allergic reaction to human, humanized or mouse monoclonal antibody;
•3. Subjects with a history of alcoholism (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of liquor, or 125 mL of wine);
•4. Subjects who have donated blood or had massive blood loss (\>450 mL) within three months prior to screening, or intend to donate blood or undergo surgery during the study;
•5. Subjects who have taken any prescription drug, over-the-counter drug, any vitamin products or herbal medicines 28 days prior to Screening;
•6. Subjects who have significant changes in diet or exercise habits 2 weeks prior to screening or from screening to administration;
•7. Subjects who have used any biological products within 3 months prior to screening;
•8. Subjects with clinical significance of abnormal heart assessed using Color Doppler echocardiography
•9. Subjects with clinical significance of abnormal laboratory findings (hematology, urinalysis, serum chemistry, coagulation function, virology of infectious diseases and pregnancy test for women of childbearing age), or other clinical findings suggestive of the following disorders with clinical relevance (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immune, psychiatric or cardiovascular and cerebrovascular diseases);
•10. Subjects with clinical significance of abnormal (as judged by the investigator) ECG, or QTcF \> 450 ms (allowed to be repeated for once);
+9 more criteria

Locations (1)

Union Hospital Tong Ji Medical College University of Science and Technology

Wuhan, Hubei, China

Key Dates

Start Date

June 9, 2022

Primary Completion Date

November 7, 2022

Completion Date

November 7, 2022

Last Updated

November 15, 2022

Enrollment

ACTUAL participants

Conditions

SARS-CoV-2 Infection

Interventions

BAT2022

DRUG

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Long COVIDSars-CoV-2 Infection+2 more

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 15, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluate the Pharmacokinetics of BAT2022 in Healthy Chinese Subjects

Inclusion Criteria

Exclusion Criteria

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