Healthy Male SubjectsPhase 1NCT06111196

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

A Phase 1 study testing Recombinant Humanized Anti-PD-1 Monoclonal Antibody Solution for Injection and Pembrolizumab injection in people with Healthy Male Subjects, run by Bio-Thera Solutions at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

to Compare the Pharmacokinetics and Safety of BAT3306 versus KEYTRUDA® Administered in Healthy Male Subjects Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Male Subjects
What is being tested?: Recombinant Humanized Anti-PD-1 Monoclonal Antibody Solution for Injection and Pembrolizumab injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 59 participants
Where: 1 siteChina
Study dates: 5 Nov 2023to 11 Jun 2024
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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;
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);
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);

Show all 23Show fewer

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;
Have had a major injury or previous surgical procedure or fracture within 4 weeks prior to study drug administration, or intend to have surgery during the study period;
Have donated blood or had a blood sample > 400ml taken as a subject within 3 months prior to screening, or plan to donate blood during the study period;
History of alcohol dependence or a positive screening/baseline alcohol test result;
Consumption of alcoholic beverages within 48h prior to study drug administration;
History of substance abuse, or positive drug abuse test results during the screening period;
Inability to comply with the study's restrictions on smoking, alcohol consumption, and concomitant medications during the study.
22. Can not stop high intensity physical exercise from the day of study drug administration till 30 days thereafter.

Trial locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

Official title: 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

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

Read the 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

Conditions: Healthy Male Subjects
Being tested: Recombinant Humanized Anti-PD-1 Monoclonal Antibody Solution for Injection, Pembrolizumab injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Recombinant Humanized Anti-PD-1 Monoclonal Antibody Solution for InjectionDrug
Also called BAT3306 injection
100mg/4ml;single dose;intravenous injection
Pembrolizumab injectionDrug
Also called KEYTRUDA® (EU-sourced)
100mg/4ml;single dose;intravenous injection

Study groups in NCT06111196
Study group	Role	What they receive
BAT3306 injection	Experimental	100mg/4ml,intravenous injection Receives: Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody Solution for Injection
KEYTRUDA® (EU-sourced)	Active comparator	100mg/4ml,intravenous injection Receives: Drug: Pembrolizumab injection

What is being measured

The primary outcome is the main question the study is designed to answer.

CL
Number of participants to single dose PK characteristics
Measured: Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113
Cmax
Number of participants to Peak plasma concentration evaluation
Measured: 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
Measured: Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113
(AUC0-t)
Number of participants to data point evaluation
Measured: Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113
Tmax
Number of participants to single dose PK characteristics evaluation
Measured: Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113
t1/2
Number of participants to PK characteristics evaluation
Measured: Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113
Vd
Number of participants to Single dose PK characteristics evaluation
Measured: Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113

Secondary outcomes (7)

Vital signs
Number of participants with abnormal vital signs
Measured: Day1,Day2,Day3,Day4,Day5,Day8,Day15,Day22,Day29,Day36,Day43,Day57,Day71,Day85,Day99,Day113,End of study
ECG parameters
Number of participants with abnormal ECG readings
Measured: Day1,Day2,Day5,Day15,Day43,Day113,End of study
Laboratory tests
Number of participants with abnormal laboratory test results
Measured: Day1,Day2,Day5,Day15,Day22,Day29,Day43,Day71,Day85,Day113,End of study
AEs, adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Day1,Day2,Day3,Day4,Day5,Day8,Day15,Day22,Day29,Day36,Day43,Day57,Day71,Day85,Day99,Day113,End of study
Injection site reactions
Number of participants with injection site reactions
Measured: Day1,Day2, Day3,Day 4, Day5, Day15;
ADA antibody
Number of participants to immunogenicity evaluation.
Measured: Day1, Day 15, Day57, Day85, and Day113
Nab positive
Number of participants to Immunogenicity evaluation when the ADA is positive.
Measured: Day1, Day 15, Day57, Day85,Day113

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 202311 Jun 2024

First posted1 Nov 2023
Study start5 Nov 2023
Primary completion11 Jun 2024
Study completion11 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy Male SubjectsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06111196
Sponsor's protocol ID: BAT-3306-001-CR
Status last verified: Oct 2024
First submitted: 21 Sep 2023
Last updated: 30 Oct 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06111196
Acronym / sponsor ID: BAT-3306-001-CR
Conditions: Healthy Male Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: Bio-Thera SolutionsIndustry (pharma, biotech, devices)
Study start: 5 Nov 2023 (actual)
Primary completion: 11 Jun 2024 (actual)
Study completion: 11 Jun 2024 (actual)
First posted: 1 Nov 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
BAT3306 injection	Experimental	Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody Solution for Injection100mg/4ml,intravenous injection
KEYTRUDA® (EU-sourced)	Active comparator	Drug: Pembrolizumab injection100mg/4ml,intravenous injection

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (23 listed)

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;
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);
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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Recombinant Humanized Anti-PD-1 Monoclonal Antibody Solution for InjectionAlso: BAT3306 injection100mg/4ml;single dose;intravenous injection	Drug	BAT3306 injection
Pembrolizumab injectionAlso: KEYTRUDA® (EU-sourced)100mg/4ml;single dose;intravenous injection	Drug	KEYTRUDA® (EU-sourced)

Primary outcome

CL
Time frame: Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113
Number of participants to single dose PK characteristics
Cmax
Time frame: Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113
Number of participants to Peak plasma concentration evaluation
AUC0-∞
Time frame: Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113
Number of participants to area under the drug concentration-time curve evaluation
(AUC0-t)
Time frame: Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113
Number of participants to data point evaluation
Tmax
Time frame: Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113
Number of participants to single dose PK characteristics evaluation
t1/2
Time frame: Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113
Number of participants to PK characteristics evaluation
Vd
Time frame: Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113
Number of participants to Single dose PK characteristics evaluation

7 secondary outcomes

Vital signs
Time frame: Day1,Day2,Day3,Day4,Day5,Day8,Day15,Day22,Day29,Day36,Day43,Day57,Day71,Day85,Day99,Day113,End of study
ECG parameters
Time frame: Day1,Day2,Day5,Day15,Day43,Day113,End of study
Laboratory tests
Time frame: Day1,Day2,Day5,Day15,Day22,Day29,Day43,Day71,Day85,Day113,End of study
AEs, adverse events
Time frame: Day1,Day2,Day3,Day4,Day5,Day8,Day15,Day22,Day29,Day36,Day43,Day57,Day71,Day85,Day99,Day113,End of study
Injection site reactions
Time frame: Day1,Day2, Day3,Day 4, Day5, Day15;
ADA antibody
Time frame: Day1, Day 15, Day57, Day85, and Day113
Nab positive
Time frame: Day1, Day 15, Day57, Day85,Day113

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Weiyong Li principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CL (time frame: Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06111196.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.