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

NCT02805010 | Unknown Phase 1

• 1 other identifier: SIM-126-I
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis (RA)

Outcome Measures

Primary Outcomes (4)

• Maximum Plasma Concentration (Cmax)

  Day1 to Day71

• Area Under the Curve (AUC)

  Day1 to Day71

• Half-life period (T1/2)

  Day1 to Day71

• Time to peak (Tmax)

  Day1 to Day71

Secondary Outcomes (3)

• Adverse event (AE)

  Signed Informed consent form (ICF) to Day 71

• anti-abatacept antibodies

  Day1 to Day 71

• Anti cytotoxic T lymphocyte-associated antigen-4(CTLA-4) antibodies

  Day1 to Day 71

Study Arms (2)

Subcutaneous(SC) Abatacept

EXPERIMENTAL

Drug: Abatacept

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Abatacept DRUG

On Day 1, subjects will receive a single SC dose of abatacept 125mg

Also known as: Orencia

Subcutaneous(SC) Abatacept

Placebo OTHER

On Day 1, subjects will receive a single SC dose of placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Subjects with tuberculosis (TB) risk, specially:
• Having clinical, imaging or lab test evidences of current active or latent pulmonary tuberculosis;
• Having active pulmonary tuberculosis during the past 3 years, even if had been treated;
• Having history of active pulmonary tuberculosis more than 3 years ago, unless the appropriate duration and types of anti-tuberculosis drug is well documented.
• Subjects with herpes zoster that resolved less than 2 months prior to enrollment;

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead
• Bristol-Myers Squibb: collaborator

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2016
• First Posted: June 17, 2016
• Study Start: October 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: December 6, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share