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

Healthy Subjects Clinical Trial

Official title:

Compare the Pharmacokinetics, Safety, Tolerance and Immunogenicity of Single Doses of IBI310 and Ipilimumab in Healthy Male Subjects: a Randomized Double-blind Parallel Controlled Phase I Clinical Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04868760
• Other study ID #: CIBI310G101
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: June 4, 2021
• Est. completion date: December 6, 2022

Study information

• Verified date: October 2022
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 148
• Est. completion date: December 6, 2022
• Est. primary completion date: September 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

To be eligible for the study, patients should fulfill all the following criteria:

1. 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.

2. Aged 18-55 years healthy male subjects

3. Weigh ranges from 50-80 kg, BMI ranges from 19.0-28.0 kg/m2

4. All the system test result within the normal range, or abnormal test results without clinical significance judged by the investigator.

5. 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)

Exclusion Criteria:

Patients should not enter the study if any of the following exclusion criteria are fulfilled:

1. Medical history of chronic liver, kidney, cardiovascular, neurological/psychiatric, digestive tract, respiratory, urinary, endocrine and other system diseases;

2. Medical history of autoimmune diseases (see Annex 1);

3. 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);

4. Have opportunistic infections within 6 months before screening (such as: herpes zoster, active cytomegalovirus, pneumocystis carinii, histoplasma, aspergillus, mycobacterium, etc.)

5. 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;

6. Acute infection within 2 weeks before screening;

7. 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;

8. 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;

9. 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;

10. Any prior using of ipilimumab;

11. Participation in any other interventional clinical trials within 3 months before screening;

12. 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.

13. Subjects underwent major surgery or hospitalization for illness within 3 months before screening;

14. Subjects have received live vaccines within 6 months prior to screening, or expect to receive live vaccines during the study period;

15. Any drug abuse or positive drug screening result within 12 months before screening;

16. Any abnormalities of vital signs and physical examination with clinical significance as judged by investigators at screening;

17. Abnormalities in the ECG with clinicavl significance judged by investigators at screening;

18. Abnormalities of chest-X ray or CT examination with clinical significance as judged by investigators at screening;

19. Abnormal laboratory tests with clinical significance at screening.

20. 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.

21. 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;

22. 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;

23. It is not suitable to participate in this clinical trial due to other reasons per investigator discretion

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

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

Locations

Country	Name	City	State
China	Huashan Hospital Affiliated to Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Concentration-time Curve (AUC0-inf)		From pre-dose to 1848hrs (78day)
Primary	Maximum Plasma Concentration (Cmax)		From pre-dose to 1848hrs (78day)
Secondary	Area Under the Concentration-time Curve		From pre-dose to 1848hrs (78day)
Secondary	Clearance		From pre-dose to 1848hrs (78day)
Secondary	Volume of distribution		From pre-dose to 1848hrs (78day)
Secondary	Positive rate of ADA and Nab		From pre-dose to 1848hrs (78day)
Secondary	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	from dosing to completion of study (183days posy-dosing) or to the patient withdrawl