Healthy Male SubjectsPhase 1NCT05337267
Phase I Study of Sintilimab in Healthy Chinese Male Subjects
A Phase 1 study testing sintilimab (after the change) and sintilimab (before the change) in people with Healthy Male Subjects, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the pharmacokinetic similarity of sintilimab with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of sintilimab with different manufacturing process，also to determine Pharmacodynamics of sintilimab with… 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 Subjects
- What is being tested?
- sintilimab (after the change) and sintilimab (before the change)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2022to 24 Jul 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
- Males aged 18 to 45 (including both ends);
- Body Mass Index (BMI) is 19.0~28.0 kg/m2 (including both ends), and body weight is 62.0~73.0kg (including both ends);
- The investigator is assessed as a healthy male subject based on a complete medical history, including physical examination, vital signs, 12-lead electrocardiogram and laboratory tests;
- Subjects agree to use reliable contraceptive measures (such as abstinence, sterilization, contraceptives, injectable contraceptive medroxyprogesterone or subcutaneous implant contraception, etc.) during the study period and within 6 months after the study drug infusion. );
- Fully understand the purpose of the trial, understand the pharmacological effects of the study drug and possible adverse reactions; and abide by the trial process and voluntarily sign the informed consent.
Who cannot join
- Those with a history of chronic liver, kidney, cardiovascular, neurological/mental, digestive tract, respiratory, urinary, endocrine and other systemic diseases;
- Those with a history of autoimmune diseases (see Annex 1);
- Regular drinkers within 6 months prior to screening (regular drinkers are defined as drinking more than 2 units per day on average, or drinking more than 14 units per week on average: 1 unit = 360ml of beer or 45ml of alcohol for 40 % above spirits or 150ml wine);
- Subjects who have had opportunistic infections within 6 months before screening (such as: herpes zoster, active cytomegalovirus, Pneumocystis carinii, histoplasma, aspergillus, mycobacteria, etc. );
- Known history of recurrent or chronic infection, history of chronic or recurrent infection, including but not limited to: chronic kidney infection, chronic chest infection (such as bronchiectasis), sinusitis, recurrent urinary tract infection, Open, draining or infected skin wounds;
- Those with a history of acute infection within 2 weeks before screening;
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- A history of malignant tumor, unless it is a skin squamous cell carcinoma or basal cell carcinoma that has been successfully resected and has no evidence of metastasis;
- Those who are suspected or confirmed to be allergic or have had severe drug or food allergy reactions in the past, have a clear history of allergies and/or are allergic to the study drug or its components after inquiries;
- Have used any drugs (including traditional Chinese medicines and vitamins) within 2 weeks before screening, or the last medication is less than 5 half-lives of the drug from the test administration day, whichever is longer;
- Those who have used anti-PD-1/PD-L1 drugs in the past;
- Those who have participated in other interventional clinical trials within 3 months before screening;
- Those who lost blood, donated blood or received any blood product transfusion of ≥400 ml within 3 months before screening;
- Those who received major surgery or hospitalization due to illness within 3 months before screening;
- Those who have been vaccinated with live vaccines within 6 months before screening, or who are expected to receive live vaccines during the study period;
- Those with a history of drug abuse or positive drug screening results within 12 months before screening;
- Those with abnormal vital signs and physical examination during the screening period and judged by the research doctor to have clinical significance;
- Abnormal electrocardiogram (such as QTcF>450ms, shortened or prolonged PR interval, second-degree and third-degree atrioventricular block, pre-excitation syndrome, etc.) during the screening period and judged by the research doctor to be clinically significant;
- Abnormal chest X-ray (frontal and lateral) or lung CT during the screening period and judged by the research doctor to have clinical significance;
- Abnormal laboratory tests and clinical significance during the screening period. (Remarks: If there is any abnormality and it has clinical significance as judged by the research doctor, if it is within the normal range after re-examination, it can also be included in the group);
- Patients with known history of tuberculosis or suspected clinical manifestations of tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.), positive test for tuberculosis laboratory test (QuantiFERON-TB tuberculosis test/T.SPOT tuberculosis test) examinee;
- Human Immunodeficiency Virus (HIV) antibody, Hepatitis C virus (HCV) antibody, syphilis test (RPR), Hepatitis B virus (HBV) surface antigen, e antigen ( Positive results for either HBeAg) or core antibody (HBcAb);
- Subjects who have a reproductive plan from the screening period to 6 months after the administration of the study drug, or who are unwilling to take the contraceptive measures specified in the protocol during the trial;
- The investigator believes that it is not suitable to participate in this clinical trial due to other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study to Evaluate PK Similarity of Recombinant Fully Human Anti-programmed Death Receptor 1 Monoclonal Antibody Injection Before and After IBI308 Manufacturing Process Change in Healthy Chinese Male Subjects
The purpose of this study is to evaluate the pharmacokinetic similarity of sintilimab with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of sintilimab with different manufacturing process，also to determine Pharmacodynamics of sintilimab with different manufacturing process in 12 healthy male subjects.
- Conditions
- Healthy Male Subjects
- Being tested
- sintilimab (after the change), sintilimab (before the change)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sintilimab (after the change)Drug
0.3mg/kg，I.V.，single dose
sintilimab (before the change)Drug
0.3mg/kg，I.V.，single dose
| Study group | Role | What they receive |
|---|---|---|
| sintilimab (after the change) | Experimental | Not described Receives: Drug: sintilimab (before the change) |
| sintilimab (before the change) | Active comparator | Not described Receives: Drug: sintilimab (after the change) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-experiment: Treatment-emergent Adverse Events (TEAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0) incidence.
Measured: Day 43
Pre-experiment: Serious Adverse Events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0) incidence.
Measured: Day 43
Formal test: Bioequivalence results using the area under the plasma concentration-time curve (AUC0-inf) as the judging indicators.
Measured: Day 57
Bioequivalence results using the peak serum drug concentration (Cmax) as the judging indicators.
Measured: Day 57
Secondary outcomes (7)
Other PK parameters: Area under the plasma concentration-time curve (AUClast)
Measured: Day 57
Other PK parameters: Volume of distribution (V)
Measured: Day 57
Other PK parameters: Clearance (CL) .
Measured: Day 57
Other PK parameters: Half-life (t1/2). Other PK parameters, including but not limited to elimination half-life (t1/2).
Measured: Day 57
The occurrence of Neutralizing antibodies Antibody(NAb)
Measured: Day 57
The occurrence of Anti-drug Antibody(ADA)
Measured: Day 57
PD indicator: PD-1 receptor occupancy rate.
Measured: Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start13 Apr 2022
- Primary completion24 May 2023
- Study completion24 Jul 2023
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.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- 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
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337267
- Sponsor's protocol ID
- CIBI308K102
- Status last verified
- Dec 2022
- First submitted
- 22 Mar 2022
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Evaluate PK Similarity of Recombinant Fully Human Anti-programmed Death Receptor 1 Monoclonal Antibody Injection Before and After IBI308 Manufacturing Process Change in Healthy Chinese Male Subjects
- ClinicalTrials.gov ID
- NCT05337267
- Acronym / sponsor ID
- CIBI308K102
- Conditions
- Healthy Male Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 20 Apr 2022 (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 of sintilimab with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of sintilimab with different manufacturing process，also to determine Pharmacodynamics of sintilimab with different manufacturing process in 12 healthy male subjects.
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 |
|---|---|---|
| sintilimab (after the change) | Experimental | Drug: sintilimab (before the change) |
| sintilimab (before the change) | Active comparator | Drug: sintilimab (after the change) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males aged 18 to 45 (including both ends);
- Body Mass Index (BMI) is 19.0~28.0 kg/m2 (including both ends), and body weight is 62.0~73.0kg (including both ends);
- The investigator is assessed as a healthy male subject based on a complete medical history, including physical examination, vital signs, 12-lead electrocardiogram and laboratory tests;
- Subjects agree to use reliable contraceptive measures (such as abstinence, sterilization, contraceptives, injectable contraceptive medroxyprogesterone or subcutaneous implant contraception, etc.) during the study period and within 6 months after the study drug infusion. );
- Fully understand the purpose of the trial, understand the pharmacological effects of the study drug and possible adverse reactions; and abide by the trial process and voluntarily sign the informed consent.
Key exclusion criteria (23 listed)
- Those with a history of chronic liver, kidney, cardiovascular, neurological/mental, digestive tract, respiratory, urinary, endocrine and other systemic diseases;
- Those with a history of autoimmune diseases (see Annex 1);
- Regular drinkers within 6 months prior to screening (regular drinkers are defined as drinking more than 2 units per day on average, or drinking more than 14 units per week on average: 1 unit = 360ml of beer or 45ml of alcohol for 40 % above spirits or 150ml wine);
- Subjects who have had opportunistic infections within 6 months before screening (such as: herpes zoster, active cytomegalovirus, Pneumocystis carinii, histoplasma, aspergillus, mycobacteria, etc. );
- Known history of recurrent or chronic infection, history of chronic or recurrent infection, including but not limited to: chronic kidney infection, chronic chest infection (such as bronchiectasis), sinusitis, recurrent urinary tract infection, Open, draining or infected skin wounds;
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 |
|---|---|---|
| sintilimab (after the change)0.3mg/kg，I.V.，single dose | Drug | sintilimab (before the change) |
| sintilimab (before the change)0.3mg/kg，I.V.，single dose | Drug | sintilimab (after the change) |
Primary outcome
Pre-experiment: Treatment-emergent Adverse Events (TEAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0) incidence.
Time frame: Day 43
Pre-experiment: Serious Adverse Events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0) incidence.
Time frame: Day 43
Formal test: Bioequivalence results using the area under the plasma concentration-time curve (AUC0-inf) as the judging indicators.
Time frame: Day 57
Bioequivalence results using the peak serum drug concentration (Cmax) as the judging indicators.
Time frame: Day 57
7 secondary outcomes
Other PK parameters: Area under the plasma concentration-time curve (AUClast)
Time frame: Day 57
Other PK parameters: Volume of distribution (V)
Time frame: Day 57
Other PK parameters: Clearance (CL) .
Time frame: Day 57
Other PK parameters: Half-life (t1/2). Other PK parameters, including but not limited to elimination half-life (t1/2).
Time frame: Day 57
The occurrence of Neutralizing antibodies Antibody(NAb)
Time frame: Day 57
The occurrence of Anti-drug Antibody(ADA)
Time frame: Day 57
PD indicator: PD-1 receptor occupancy rate.
Time frame: Day 57
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 21 Aug 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sintilimab (after the change) and sintilimab (before the change) in people with Healthy Male Subjects, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
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 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 21 Aug 2023. 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?
Pre-experiment: Treatment-emergent Adverse Events (TEAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0) incidence. (time frame: Day 43). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2023.