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

Jiangsu Simcere Pharmaceutical Co., Ltd.0 sites22 target enrollmentOctober 2016

ConditionsRheumatoid Arthritis (RA)

InterventionsAbatacept Placebo

DrugsAbatacept

Overview

Phase: Phase 1
Intervention: Abatacept
Conditions: Rheumatoid Arthritis (RA)
Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Enrollment: 22
Primary Endpoint: Maximum Plasma Concentration (Cmax)
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The objective of the study is to assess the single dose PK, safety, tolerability and immunogenicity of abatacept 125mg administered SC in Chinese healthy subjects.

Registry

clinicaltrials.gov

Start Date

October 2016

End Date

February 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects are willing to participate in this study and signed informed consent;
•Healthy subjects, as determined by no clinically significant deviation from normal in medical history, physical examination, Electrocardiograph（ECG）, and clinical laboratory determinations;
•Body weight for male must be≥50 kg, for female be≥45 kg, and all subjects must be ≤100kg;
•Body mass index (BMI) is 19-26 kg/m2 (boundary value included), \[BMI = body weight (kg) / height (m)2\];
•Men and women, 18-45 years old (boundary value included);
•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;
•WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal. Post-menopausal is defined as: Amenorrhea ≥ 12 consecutive months without another cause, or for women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level \> 35 mIU/mL;
•Women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential;
•WOCBP must have a negative serum pregnancy test within 24 hours prior to study medication administration.

Exclusion Criteria

•WOCBP and males subjects of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 10 weeks after administration of the study medication;
•Women who are pregnant or breast-feeding;
•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;
•Any major surgery within 4 weeks of enrollment;
•Splenectomized subjects;
•Exposed to any investigational medication within 3 months of enrollment, or plan to receive other investigational medication during the study;
•Donation of blood or plasma within 3 months of enrollment, or plan to donate blood or plasma during the study or within one month after the end of the study;
•Blood transfusion within 4 weeks prior to enrollment;
•Subjects who is a current smoker (defined as individuals who smoked for more than 6 months, and smoked for ≥ 5 cigarettes per day before screening), ≥ 3 cups of coffee or other coffee drinks or ≥ 5 cups of tea per day;
•Subjects who have a history of drug or alcohol abuse;

Arms & Interventions

Subcutaneous(SC) Abatacept

Intervention: Abatacept

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Maximum Plasma Concentration (Cmax)

Time Frame: Day1 to Day71

Area Under the Curve (AUC)

Time Frame: Day1 to Day71

Time to peak (Tmax)

Time Frame: Day1 to Day71

Half-life period (T1/2)

Time Frame: Day1 to Day71

Secondary Outcomes

Anti cytotoxic T lymphocyte-associated antigen-4(CTLA-4) antibodies(Day1 to Day 71)
anti-abatacept antibodies(Day1 to Day 71)
Adverse event (AE)(Signed Informed consent form (ICF) to Day 71)