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Compare the Pharmacokinetics and Safety of BAT3306 Injection Versus KEYTRUDA® Administered in Healthy Male Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Compare the Pharmacokinetics and Safety of BAT3306 Injection Versus KEYTRUDA® Administered in Healthy Male Subjects

A Randomized, Double-blind, Single-dose, Three-arm Parallel Group, Phase I Study to Compare the Pharmacokinetics and Safety of BAT3306 Versus KEYTRUDA® Administered in Healthy Male Subjects

NCT06111196•Bio-Thera Solutions

View on ClinicalTrials.gov

Summary

to Compare the Pharmacokinetics and Safety of BAT3306 versus KEYTRUDA® Administered in Healthy Male Subjects

Detailed Description

A Randomized, Double-blind, Single-dose, Three-arm Parallel Group, Phase I Study to Compare the Pharmacokinetics and Safety of BAT3306 versus KEYTRUDA® Administered in Healthy Male Subjects

Eligibility

Age

18 - 55 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•The subjects must sign the informed consent before they can start the screening procedure and entering the clinical study. They can only be included if they meet all the following criteria:
•1. Adult males aged 18 to 55 years inclusive and with 18.0 to 28.0 kg/m2 body mass index (BMI) and body weight should between 50 to 85 kg（all contain boundary values）;
•2. Subject is able to understand and to comply with protocol requirements, instructions, and restrictions, voluntarily agrees to participate in this study and has given a written informed consent prior to performing any of the screening procedures;
•3. Physical examination, vital signs, 12-lead ECG, laboratory tests and other examination results of the subjects are normal or abnormal but with no clinical significance;
•4. Non-smokers or smokers of less than 5 cigarettes per day for less than 10 years;
•5. Agree to take effective contraception measures (including but not limited to: hormonal contraception, or physical contraception, or abstinence) and no sperm donation plan from the time of signing the informed consent form until 6 months after injection of study drug; 6. Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other relevant procedures specified in this study.

Exclusion Criteria

•Subjects meeting any of the following shall not be included:
•1. Have a history of and/or current clinically significant gastrointestinal (including but not limited to diverticulitis, stomach ulcers), renal, hepatic, cardiovascular, haematological， pulmonary, neurologic, metabolic (including but not limited to known diabetes mellitus), psychiatric or allergic disease excluding mild asymptomatic seasonal allergies, and other diseases that the investigator considers unsuitable for participation in this clinical study;
•2. Subject with a psychiatric disorder or considered unsuitable for inclusion by the investigator (e.g., inability to understand and/or comply with study requirements or presence of any condition which, in the opinion of the investigator, would not allow safe participation in the study);
•3. Previous or current clinically significant allergic disease(excluding mild asymptomatic seasonal allergy); or it is known or suspected that the subject may have allergic or hypersensitive reactions to any component of the study drug; or it is known or suspected that the subject may have allergic or hypersensitive reactions to hamster ovary cell products or other recombinant human or humanized antibodies;
•4. Have a history of autoimmune disease and presence of thyroid function disorders or related history (e.g., hyperthyroidism, hypothyroidism, and other thyroid disorders);
•5. Propensity for bleeding or thrombosis, or a history of non-traumatic bleeding with appropriate clinical treatment, or a history of thrombosis, or the presence of any disease that may put the subject at increased risk of bleeding or thrombosis(such as abnormal coagulation, thrombocytopenia, or INR \> 1.5);
•6. History of any malignancy;
•7. Abnormal ECG with clinical significance (as judged by the investigator) or QT interval \> 450 ms after Bazett correction (Bazett formula: Q-Tc = QT/(R-R)\^0.5, where R-R denotes the interval between two R waves in s);
•8. History of hypertension or systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg at screening or baseline;
•9. Have clinically significant chronic or acute infections at the time of screening/ enrollment; or Hepatitis B surface antigen (HBsAg) positive, or HCV, or HIV, or syphilis specific antibody test results show positive during the screening period;
+13 more criteria

Locations (1)

Union Hospital,Tong Ji Medical College,Huazhong University of Science and Technology

Wuhan, Hubei, China

Key Dates

Start Date

November 5, 2023

Primary Completion Date

June 11, 2024

Completion Date

June 11, 2024

Last Updated

October 30, 2024

Enrollment

ACTUAL participants

Conditions

Healthy Male Subjects

Interventions

Recombinant Humanized Anti-PD-1 Monoclonal Antibody Solution for Injection

DRUG

Pembrolizumab injection

DRUG

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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: October 30, 2024Data 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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Compare the Pharmacokinetics and Safety of BAT3306 Injection Versus KEYTRUDA® Administered in Healthy Male Subjects

Inclusion Criteria

Exclusion Criteria

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