Healthy MalePhase 1NCT05849311

Phase I Trial of Envafolimab for Healthy Male Subjects

A Phase 1 study testing Envafolimab with new manufacturing process and Envafolimab with old manufacturing process in people with Healthy Male, run by 3D Medicines (Sichuan) Co., Ltd. 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

The purpose of this study is to evaluate the pharmacokinetic similarity, safety, and immunogenicity of Envafolimab in healthy male subjects before and after the manufacturing process change. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Male
What is being tested?: Envafolimab with new manufacturing process and Envafolimab with old manufacturing process
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 1 siteChina
Study dates: 29 May 2023to 20 Nov 2023
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 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Be able to fully read, understand, and sign the informed consent form;
Male subjects aged 18-45 years
Clinical examinations in the screening period are normal or abnormal without clinical significance;
A body mass index (BMI) in the range of 19 to 26 kg/m22, and a body weight between 50 and 85 kg;
Use effective contraceptive methods from the beginning of the informed consent to 5 months after the use of the drug, and have no plans to give birth or donate sperm.

Who cannot join

Systolic blood pressure ≥140 mmHg/ diastolic blood pressure ≥90 mmHg or systolic blood pressure < 90 mmHg/ diastolic blood pressure < 60 mmHg, pulse > 100 beats /min or < 50 beats /min at screening or baseline examination;
QT interval (QTcF) ≥450;
Estimated glomerular filtration rate eGFR < 90 ml/min/1.73m2;
Thyroid function beyond the normal range;
ALT > ULN Or AST > ULN;
Prior treatment with a PD-1/L1 inhibitor;

Show all 9Show fewer

Have taken any prescription drug, over-the-counter drug, any vitamin product or herbal or health product within 14 days prior to study drug administration;
Had a history of upper respiratory tract infection or other acute infection within 14 days prior to study drug administration;
Positive hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody or syphilis.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Gaobo Boren Hosipital
Beijing, Beijing Municipality, 100070

Other trials in China

About this study

Official title: A Randomized, Double-blind, Single-dose, Parallel Controlled Phase I Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Envafolimab in Healthy Male Subjects Before and After the Manufacturing Process Change

The purpose of this study is to evaluate the pharmacokinetic similarity, safety, and immunogenicity of Envafolimab in healthy male subjects before and after the manufacturing process change.

Conditions: Healthy Male
Being tested: Envafolimab with new manufacturing process, Envafolimab with old manufacturing process

What participants receive

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

Envafolimab with new manufacturing processDrug
Dosage form:
Envafolimab is a monoclonal antibody drug administered subcutaneously in a minimum packaging unit of 1.0 ml solution in a single-use glass vial containing a total of 200 mg of Envafolimab.
Treatment method:
Envafolimab, single dose, 1 mg/kg, subcutaneously.
Envafolimab with old manufacturing processDrug
Dosage form:
Envafolimab is a monoclonal antibody drug administered subcutaneously in a minimum packaging unit of 1.0 ml solution in a single-use glass vial containing a total of 200 mg of Envafolimab.
Treatment method:
Envafolimab, single dose, 1 mg/kg, subcutaneously.

Study groups in NCT05849311
Study group	Role	What they receive
Envafolimab with new manufacturing process	Experimental	80 healthy male subjects with Envafolimab with new manufacturing process Receives: Drug: Envafolimab with new manufacturing process
Envafolimab with old manufacturing process	Active comparator	80 healthy male subjects with Envafolimab with old manufacturing process Receives: Drug: Envafolimab with old manufacturing process

What is being measured

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

AUC0-t
Area under the plasma concentration-time curve
Measured: From pre-dose to day 85
Cmax
concentration
Measured: From pre-dose to day 85

Secondary outcomes (8)

AUC0-infinity
Area under the plasma concentration-time curve
Measured: From pre-dose to day 85
Tmax
Time to maximum concentration
Measured: From pre-dose to day 85
CL
Clearance
Measured: From pre-dose to day 85
λz
Apparent terminal elimination rate constant
Measured: From pre-dose to day 85
t1/2
Half-life (
Measured: From pre-dose to day 85
Vd
Volume of distribution
Measured: From pre-dose to day 85
Safety and tolerance
Adverse events (AE)
Measured: From pre-dose to day 85
Immunogenicity assessment
Anti-drug Antibody (ADA)
Measured: From pre-dose to day 85

Timeline

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

29 May 202320 Nov 2023

First posted8 May 2023
Study start29 May 2023
Primary completion15 Nov 2023
Study completion20 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy MaleStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05849311
Sponsor's protocol ID: KN035-CN-BE
Status last verified: Jul 2023
First submitted: 27 Apr 2023
Last updated: 14 Aug 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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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All Healthy Male trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Single-dose, Parallel Controlled Phase I Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Envafolimab in Healthy Male Subjects Before and After the Manufacturing Process Change
ClinicalTrials.gov ID: NCT05849311
Acronym / sponsor ID: KN035-CN-BE
Conditions: Healthy Male
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: 3D Medicines (Sichuan) Co., Ltd.Industry (pharma, biotech, devices)
Study start: 29 May 2023 (actual)
Primary completion: 15 Nov 2023 (actual)
Study completion: 20 Nov 2023 (actual)
First posted: 8 May 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.

The purpose of this study is to evaluate the pharmacokinetic similarity, safety, and immunogenicity of Envafolimab in healthy male subjects before and after the manufacturing process change.

Study design

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

Arm	Type	Receives
Envafolimab with new manufacturing process	Experimental	Drug: Envafolimab with new manufacturing process80 healthy male subjects with Envafolimab with new manufacturing process
Envafolimab with old manufacturing process	Active comparator	Drug: Envafolimab with old manufacturing process80 healthy male subjects with Envafolimab with old manufacturing process

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Be able to fully read, understand, and sign the informed consent form;
Male subjects aged 18-45 years
Clinical examinations in the screening period are normal or abnormal without clinical significance;
A body mass index (BMI) in the range of 19 to 26 kg/m22, and a body weight between 50 and 85 kg;
Use effective contraceptive methods from the beginning of the informed consent to 5 months after the use of the drug, and have no plans to give birth or donate sperm.

Key exclusion criteria (9 listed)

Systolic blood pressure ≥140 mmHg/ diastolic blood pressure ≥90 mmHg or systolic blood pressure < 90 mmHg/ diastolic blood pressure < 60 mmHg, pulse > 100 beats /min or < 50 beats /min at screening or baseline examination;
QT interval (QTcF) ≥450;
Estimated glomerular filtration rate eGFR < 90 ml/min/1.73m2;
Thyroid function beyond the normal range;
ALT > ULN Or AST > ULN;

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
Envafolimab with new manufacturing processDosage form: Envafolimab is a monoclonal antibody drug administered subcutaneously in a minimum packaging unit of 1.0 ml solution in a single-use glass vial containing a total of 200 mg of Envafolimab. Treatment method: Envafolimab, single dose, 1 mg/kg, subcutaneously.	Drug	Envafolimab with new manufacturing process
Envafolimab with old manufacturing processDosage form: Envafolimab is a monoclonal antibody drug administered subcutaneously in a minimum packaging unit of 1.0 ml solution in a single-use glass vial containing a total of 200 mg of Envafolimab. Treatment method: Envafolimab, single dose, 1 mg/kg, subcutaneously.	Drug	Envafolimab with old manufacturing process

Primary outcome

AUC0-t
Time frame: From pre-dose to day 85
Area under the plasma concentration-time curve
Cmax
Time frame: From pre-dose to day 85
concentration

8 secondary outcomes

AUC0-infinity
Time frame: From pre-dose to day 85
Tmax
Time frame: From pre-dose to day 85
CL
Time frame: From pre-dose to day 85
λz
Time frame: From pre-dose to day 85
t1/2
Time frame: From pre-dose to day 85
Vd
Time frame: From pre-dose to day 85
Safety and tolerance
Time frame: From pre-dose to day 85
Immunogenicity assessment
Time frame: From pre-dose to day 85

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 14 Aug 2024.
Individual participant dataSharing planned: Undecided

Related trials for Healthy Male

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Not yet recruitingPhase 1
A Clinical Trial of MK-6916 in Participants With Moderate and Severe Kidney Disease Compared to Healthy Controls (MK-6916-013)
Healthy, Renal Impairment
RecruitingPhase 1
A Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Subjects With Normal Renal Function
Participants With Moderate and Severe Renal Impairment and Healthy Participants
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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.

Qing He principal investigator

Beijing Goboard Boren Hospital

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 5 inclusion and 9 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 14 Aug 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?

AUC0-t (time frame: From pre-dose to day 85). The study lists 2 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 NCT05849311.

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 14 Aug 2024.