Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered Subcutaneously

• 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
• URL: http://www.chictr.org.cn/showproj.aspx?proj=14630
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: I (Phase I study)

Countries of recruitment

China

Contacts

• Name: Shuanghu
• Affiliation: Jiangsu Simcere Pharmaceutical R&D Co. Ltd

• Name: Yanhua Ding
• 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

Intervention(s)

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;

Source(s) of Monetary Support

Jiangsu Simcere Pharmaceutical R&D Co. Ltd