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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04868760

Enrollment

148

Registered

2021-05-03

Start date

2021-05-31

Completion date

2022-05-02

Last updated

2025-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Brief summary

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

Interventions

DRUGIpilimumab

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

DRUGIBI310

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Maximum Plasma Concentration (Cmax)	From pre-dose to 1848hrs (78day)
Area Under the Concentration-time Curve (AUC0-inf)	From pre-dose to 1848hrs (78day)

Secondary

Measure	Time frame	Description
Volume of distribution	From pre-dose to 1848hrs (78day)	—
Area Under the Concentration-time Curve	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	Number of subjects with AE，treatment-related AE (TRAE), immune-related AEs (irAE), serious adverse SAE assessed by CTCAE V5.0
Positive rate of ADA and Nab	From pre-dose to 1848hrs (78day)	—
Clearance	From pre-dose to 1848hrs (78day)	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026