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

NCT06111196 | Completed Phase 1

• 1 other identifier: BAT-3306-001-CR
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Male Subjects

Outcome Measures

Primary Outcomes (7)

• CL

  Number of participants to single dose PK characteristics

  Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113

• Cmax

  Number of participants to Peak plasma concentration evaluation

  Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113

• AUC0-∞

  Number of participants to area under the drug concentration-time curve evaluation

  Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113

• (AUC0-t)

  Number of participants to data point evaluation

  Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113

• Tmax

  Number of participants to single dose PK characteristics evaluation

  Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113

• t1/2

  Number of participants to PK characteristics evaluation

  Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113

• Vd

  Number of participants to Single dose PK characteristics evaluation

  Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113

Secondary Outcomes (7)

• Vital signs

  Day1,Day2,Day3,Day4,Day5,Day8,Day15,Day22,Day29,Day36,Day43,Day57,Day71,Day85,Day99,Day113,End of study

• ECG parameters

  Day1,Day2,Day5,Day15,Day43,Day113,End of study

• Laboratory tests

  Day1,Day2,Day5,Day15,Day22,Day29,Day43,Day71,Day85,Day113,End of study

• AEs, adverse events

  Day1,Day2,Day3,Day4,Day5,Day8,Day15,Day22,Day29,Day36,Day43,Day57,Day71,Day85,Day99,Day113,End of study

• Injection site reactions

  Day1,Day2, Day3,Day 4, Day5, Day15;

Study Arms (2)

BAT3306 injection

EXPERIMENTAL

100mg/4ml,intravenous injection

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

KEYTRUDA® (EU-sourced)

ACTIVE COMPARATOR

100mg/4ml,intravenous injection

Drug: Pembrolizumab injection

Interventions

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

100mg/4ml;single dose;intravenous injection

Also known as: BAT3306 injection

BAT3306 injection

Pembrolizumab injection DRUG

100mg/4ml;single dose;intravenous injection

Also known as: KEYTRUDA® (EU-sourced)

KEYTRUDA® (EU-sourced)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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）;
• 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;
• 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;
• Non-smokers or smokers of less than 5 cigarettes per day for less than 10 years;
• 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.

You may not qualify if:

• Subjects meeting any of the following shall not be included:
• 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;
• 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;
• Have a history of autoimmune disease and presence of thyroid function disorders or related history (e.g., hyperthyroidism, hypothyroidism, and other thyroid disorders);
• 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);
• History of any malignancy;
• 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);
• History of hypertension or systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg at screening or baseline;
• 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;
• Any prior exposure to Pembrolizumab or anti-PD-1 / L1 antibody (including monoclonal antibody, bispecific antibody and relevant target drugs);
• Use of any biologic product within 3 months or any monoclonal antibody within 9 months prior to the study drug administration;
• Use of prescription or over-the-counter medication within 14 days prior to study drug administration, or last dose is less than 5 half-lives from the date of administration of this study (whichever is longer);
• Have used any herbal medicine or proprietary Chinese medicine within 14 days prior to study drug administration,;
• Participated in another drug clinical trial within 3 months prior to study drug administration,, or intend to participate in another drug clinical trial during this study;
• Live / attenuated or mRNA vaccine received within 4 weeks prior to study drug administration or planned to vaccination during the study;

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (1)

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

Wuhan, Hubei, China

Location

MeSH Terms

Interventions

Injections; pembrolizumab

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Weiyong Li

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: November 1, 2023
• Study Start: November 5, 2023
• Primary Completion: June 11, 2024
• Study Completion: June 11, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)