A Study to Evaluate the Similarity in Pharmacokinetics and Safety of IBI310 and Ipilimumab（YERVOY）in Adult Healthy Chinese Male Volunteers

NCT04868760 | Completed Phase 1

• 1 other identifier: CIBI310G101
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

This trail will investigate the pharmacokinetics and safety of IBI310 and establish pharmacokinetics biosimilarity of IBI310 to ipilimumab （YERVOY）

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-time Curve (AUC0-inf)

  From pre-dose to 1848hrs (78day)

• Maximum Plasma Concentration (Cmax)

  From pre-dose to 1848hrs (78day)

Secondary Outcomes (5)

• Area Under the Concentration-time Curve

  From pre-dose to 1848hrs (78day)

• Clearance

  From pre-dose to 1848hrs (78day)

• Volume of distribution

  From pre-dose to 1848hrs (78day)

• Positive rate of ADA and Nab

  From pre-dose to 1848hrs (78day)

• incidence and severity of adverse events

  from dosing to completion of study (183days posy-dosing) or to the patient withdrawl

Study Arms (2)

Group B: ipilimumab

ACTIVE COMPARATOR

Ipilimumab, 0.1 and 0.3mg/kg, will be administrated intravenously in 30-60 minutes.

Drug: Ipilimumab

Group A: IBI310

EXPERIMENTAL

IBI 310, 0.1 and 0.3mg/kg, will be administrated intravenously in 30-60 minutes.

Drug: IBI310

Interventions

Ipilimumab DRUG

Drug: Ipilimumab 0.1 mg/kg and 0.3 mg/kg in preparatory experiments and 0.3 mg/kg in formal experiment.

Group B: ipilimumab

IBI310 DRUG

Drug: IBI310 0.1 mg/kg and 0.3 mg/kg in preparatory experiments and 0.3 mg/kg in formal experiment.

Group A: IBI310

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Huashan Hospital Affiliated to Fudan University

Shanghai, China

Location

MeSH Terms

Interventions

Ipilimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: May 3, 2021
• Study Start: May 31, 2021
• Primary Completion: May 2, 2022
• Study Completion: May 2, 2022
• Last Updated: April 13, 2025

Record last verified: 2022-10

Locations

CN (1)