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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ChiCTR
Last refreshed on: 18 April 2017
Main ID:  ChiCTR-IIR-16008693
Date of registration: 2016-06-20
Prospective Registration: Yes
Primary sponsor: The First Hospital, Jilin University
Public title: Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered Subcutaneously
Scientific title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Single Dose of Abatacept 125mg Administered Subcutaneously in Chinese Healthy Subjects
Date of first enrolment: 2016-08-20
Target sample size: Abatacept Group:20;Placebo Group:2;
Recruitment status: Pending
Study type:  Interventional study
Study design:  Randomized parallel controlled trial  
Phase:  I (Phase I study)
Countries of recruitment
Name: Shuanghu   
Address:  699-18 Xuanwu Avenue, Xuanwu District, Nanjing, Jiangsu, China
Telephone: +86 25 8556 0000-1826
Affiliation:  Jiangsu Simcere Pharmaceutical R&D Co. Ltd
Name: Yanhua Ding   
Address:  71 Xinmin Street, Changchun, Jilin, China
Telephone: +86 431 88782168
Affiliation:  The First Hospital, Jilin University
Key inclusion & exclusion criteria
Inclusion criteria: (1) Subjects are willing to participate in this study and signed informed consent;
(2) Healthy subjects, as determined by no clinically significant deviation from normal in medical history, physical examination, Electrocardiograph(ECG), and clinical laboratory determinations;
(3) Body weight for male must be>=50 kg, for female be>=45 kg, and all subjects must be <=100kg;
(4) Body mass index (BMI) is 19-26 kg/m2 (boundary value included);
(5) Men and women 18-45 years old (boundary value included);
(6) Women of child bearing potential (WOCBP) must be using the adequate method of contraception to avoid pregnancy throughout the study, for 4 weeks before and for up to 10 weeks after administration of abatacept, male subjects of childbearing potential must be using an adequate method of contraception throughout the study and for up to 10 weeks after administration of investigational product in such a manner that risk of pregnancy is minimized;
(7) WOCBP must have a negative serum pregnancy test within 24 hours prior to study medication administration.

Exclusion criteria: (1) Women who are pregnant or breast-feeding;
(2) History or concurrent diseases of central nervous system, cardiovascular system, renal, hepatic, digestive tract, respiratory system, metabolism and musculoskeletal system. (including but not limited to arrhythmia, bradycardia, hypotension, coronary heart disease, bronchial asthma, diabetes, hyperthyroidism, Parkinson's disease, epilepsy, shaking palsy, cancer, etc.). Or any other diseases or physiological abnormalities, which might affect study results;
(3) Exposed to any investigational medication within 3 months of enrollment, or plan to receive other investigational medication during the study;
(4) Prior exposure to abatacept (CTLA4-Ig), belatacept (LEA29Y) or any leukocyte depleting agent;
(5) Other exclusion criteria.

Age minimum: 18
Age maximum: 45
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Abatacept Group:Single dose of abatacept;Placebo Group:Single dose of placebo;
Primary Outcome(s)
PK parameters;
Secondary Outcome(s)
Anti-abatacept antibodies and anti-CTLA-4-T antibodies;AE;
Secondary ID(s)
Source(s) of Monetary Support
Jiangsu Simcere Pharmaceutical R&D Co. Ltd
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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