Healthy SubjectsPhase 1NCT04868760
A Study to Evaluate the Similarity in Pharmacokinetics and Safety of IBI310 and Ipilimumab（YERVOY）in Adult Healthy Chinese Male Volunteers
A Phase 1 study testing Ipilimumab and IBI310 in people with Healthy Subjects, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This trail will investigate the pharmacokinetics and safety of IBI310 and establish pharmacokinetics biosimilarity of IBI310 to ipilimumab （YERVOY） 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 Subjects
- What is being tested?
- Ipilimumab and IBI310
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2021to 2 May 2022
- 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
- To be eligible for the study, patients should fulfill all the following criteria:
- Fully understand the study purpose, and understand the pharmacological effects and potential adverse reactions of the drug, voluntarily signed written informed consent according to the declaration of Helsinki.
- Aged 18-55 years healthy male subjects
- Weigh ranges from 50-80 kg， BMI ranges from 19.0-28.0 kg/m2
- All the system test result within the normal range, or abnormal test results without clinical significance judged by the investigator.
- The subjects must agree to use effective contraceptive measures during the study treatment and for 6 months after receiving last does of study drug (e.g. abstinence, sterilization surgery, oral contraceptives, contraception by progesterone injection or subcutaneous)
Who cannot join
- Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- Medical history of chronic liver, kidney, cardiovascular, neurological/psychiatric, digestive tract, respiratory, urinary, endocrine and other system diseases;
- Medical history of autoimmune diseases (see Annex 1);
- People who drink frequently in the 6 months before screening (the definition of frequent drinking is defined as drinking more than 2 units per day on average, or drinking more than 14 units of alcohol per week on average: 1 unit = 360ml of beer or 45ml of alcohol is 40 % Of spirits or 150ml wine);
- Have opportunistic infections within 6 months before screening (such as: herpes zoster, active cytomegalovirus, pneumocystis carinii, histoplasma, aspergillus, mycobacterium, etc.)
- Medical history of recurrence or chronic infection, have had chronic or recurrent infections, including but not limited to: chronic kidney infection, chronic chest infection (such as bronchiectasis), sinusitis, recurrent urinary tract infections, those with open, draining or infected skin wounds;
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- Acute infection within 2 weeks before screening;
- Medical history of malignant tumors, unless they are squamous cell carcinoma of the skin, basal cell carcinoma or local cervical carcinoma in situ that have been successfully removed and have no evidence of metastasis;
- Suspected or confirmed to be allergic or have experienced severe drug or food allergic reactions in the past, have clear history of allergies and/or are allergic to test drugs or their ingredients;
- Any drugs (including Chinese medicines and vitamins) have been used within 2 weeks before the screening, or the last dose is less than 5 half-lives of the drug from the trial dosing day, whichever is longe;
- Any prior using of ipilimumab;
- Participation in any other interventional clinical trials within 3 months before screening;
- Subjects have made a blood donation or a comparable blood lossor received any blood transfusion (>400 mL) within the last 3 months prior to screening.
- Subjects underwent major surgery or hospitalization for illness within 3 months before screening;
- Subjects have received live vaccines within 6 months prior to screening, or expect to receive live vaccines during the study period;
- Any drug abuse or positive drug screening result within 12 months before screening;
- Any abnormalities of vital signs and physical examination with clinical significance as judged by investigators at screening;
- Abnormalities in the ECG with clinicavl significance judged by investigators at screening;
- Abnormalities of chest-X ray or CT examination with clinical significance as judged by investigators at screening;
- Abnormal laboratory tests with clinical significance at screening.
- Known Tuberculosis (TB) disease, high risk of acquiring TB infection, or latent TB infection (including but not limited to tuberculosis, lymphatic tuberculosis, tuberculous pleurisy, etc.), tuberculosis laboratory examination (QuantiFERON-TB tuberculosis test/T.SPOT tuberculosis test) is positive.
- Human Immunodeficiency Virus (HIV) antibody, Hepatitis C virus (HCV) antibody, Syphilis test (RPR), Hepatitis B virus (HBV) surface antigen, e antigen ( HBeAg) or core antibody (HBcAb) is positive;
- Have a childbirth plan within 6 months from the screening period to the trial drug administration, or who are unwilling to take the contraceptive measures specified in the protocol during the trial period;
- It is not suitable to participate in this clinical trial due to other reasons per investigator discretion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compare IBI310 and Ipilimumab on the Pharmacokinetics, Safety, Tolerance and Immunogenicity of a Single Dose In Healthy Male Subjects: a Randomized Double-blind Parallel Controlled Phase I Clinical Study
This trail will investigate the pharmacokinetics and safety of IBI310 and establish pharmacokinetics biosimilarity of IBI310 to ipilimumab （YERVOY）
- Conditions
- Healthy Subjects
- Being tested
- Ipilimumab, IBI310
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabDrug
Drug: Ipilimumab 0.1 mg/kg and 0.3 mg/kg in preparatory experiments and 0.3 mg/kg in formal experiment.
IBI310Drug
Drug: IBI310 0.1 mg/kg and 0.3 mg/kg in preparatory experiments and 0.3 mg/kg in formal experiment.
| Study group | Role | What they receive |
|---|---|---|
| Group B: ipilimumab | Active comparator | Ipilimumab, 0.1 and 0.3mg/kg, will be administrated intravenously in 30-60 minutes. Receives: Drug: Ipilimumab |
| Group A: IBI310 | Experimental | IBI 310, 0.1 and 0.3mg/kg, will be administrated intravenously in 30-60 minutes. Receives: Drug: IBI310 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-time Curve (AUC0-inf)
Measured: From pre-dose to 1848hrs (78day)
Maximum Plasma Concentration (Cmax)
Measured: From pre-dose to 1848hrs (78day)
Secondary outcomes (5)
Area Under the Concentration-time Curve
Measured: From pre-dose to 1848hrs (78day)
Clearance
Measured: From pre-dose to 1848hrs (78day)
Volume of distribution
Measured: From pre-dose to 1848hrs (78day)
Positive rate of ADA and Nab
Measured: From pre-dose to 1848hrs (78day)
incidence and severity of adverse events
Number of subjects with AE，treatment-related AE (TRAE), immune-related AEs (irAE), serious adverse SAE assessed by CTCAE V5.0
Measured: from dosing to completion of study (183days posy-dosing) or to the patient withdrawl
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start31 May 2021
- Primary completion2 May 2022
- Study completion2 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 148 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
- NCT04868760
- Sponsor's protocol ID
- CIBI310G101
- Status last verified
- Oct 2022
- First submitted
- 23 Apr 2021
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare IBI310 and Ipilimumab on the Pharmacokinetics, Safety, Tolerance and Immunogenicity of a Single Dose In Healthy Male Subjects: a Randomized Double-blind Parallel Controlled Phase I Clinical Study
- ClinicalTrials.gov ID
- NCT04868760
- Acronym / sponsor ID
- CIBI310G101
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 May 2021 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 3 May 2021 (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.
This trail will investigate the pharmacokinetics and safety of IBI310 and establish pharmacokinetics biosimilarity of IBI310 to ipilimumab （YERVOY）
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B: ipilimumab | Active comparator | Drug: IpilimumabIpilimumab, 0.1 and 0.3mg/kg, will be administrated intravenously in 30-60 minutes. |
| Group A: IBI310 | Experimental | Drug: IBI310IBI 310, 0.1 and 0.3mg/kg, will be administrated intravenously in 30-60 minutes. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Fully understand the study purpose, and understand the pharmacological effects and potential adverse reactions of the drug, voluntarily signed written informed consent according to the declaration of Helsinki.
- Aged 18-55 years healthy male subjects
- Weigh ranges from 50-80 kg， BMI ranges from 19.0-28.0 kg/m2
- All the system test result within the normal range, or abnormal test results without clinical significance judged by the investigator.
- The subjects must agree to use effective contraceptive measures during the study treatment and for 6 months after receiving last does of study drug (e.g. abstinence, sterilization surgery, oral contraceptives, contraception by progesterone injection or subcutaneous)
Key exclusion criteria (24 listed)
- Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- Medical history of chronic liver, kidney, cardiovascular, neurological/psychiatric, digestive tract, respiratory, urinary, endocrine and other system diseases;
- Medical history of autoimmune diseases (see Annex 1);
- People who drink frequently in the 6 months before screening (the definition of frequent drinking is defined as drinking more than 2 units per day on average, or drinking more than 14 units of alcohol per week on average: 1 unit = 360ml of beer or 45ml of alcohol is 40 % Of spirits or 150ml wine);
- Have opportunistic infections within 6 months before screening (such as: herpes zoster, active cytomegalovirus, pneumocystis carinii, histoplasma, aspergillus, mycobacterium, etc.)
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 |
|---|---|---|
| IpilimumabDrug: Ipilimumab 0.1 mg/kg and 0.3 mg/kg in preparatory experiments and 0.3 mg/kg in formal experiment. | Drug | Group B: ipilimumab |
| IBI310Drug: IBI310 0.1 mg/kg and 0.3 mg/kg in preparatory experiments and 0.3 mg/kg in formal experiment. | Drug | Group A: IBI310 |
Primary outcome
Area Under the Concentration-time Curve (AUC0-inf)
Time frame: From pre-dose to 1848hrs (78day)
Maximum Plasma Concentration (Cmax)
Time frame: From pre-dose to 1848hrs (78day)
5 secondary outcomes
Area Under the Concentration-time Curve
Time frame: From pre-dose to 1848hrs (78day)
Clearance
Time frame: From pre-dose to 1848hrs (78day)
Volume of distribution
Time frame: From pre-dose to 1848hrs (78day)
Positive rate of ADA and Nab
Time frame: From pre-dose to 1848hrs (78day)
incidence and severity of adverse events
Time frame: from dosing to completion of study (183days posy-dosing) or to the patient withdrawl
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 13 Apr 2025.
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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 Ipilimumab and IBI310 in people with Healthy 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 6 inclusion and 24 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 13 Apr 2025. 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?
Area Under the Concentration-time Curve (AUC0-inf) (time frame: From pre-dose to 1848hrs (78day)). 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?
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 13 Apr 2025.