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Rheumatoid Arthritis (RA)Phase 1NCT02805010

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

A Phase 1 study testing Abatacept in people with Rheumatoid Arthritis (RA), run by Jiangsu Simcere Pharmaceutical Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Rheumatoid Arthritis (RA)
What is being tested?
Abatacept
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
22 participants
Where
No sites listed yet
Study dates
Oct 2016to Feb 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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;
  • Subjects who had any acute or chronic bacterial infection in the previous 3 months prior to enrollment;
  • Subjects who have acute and latent bacterial and viral infection (as assessed by the investigator) at the time of enrollment, including subjects with evidence of Human Immunodeficiency Virus (HIV) infection;
  • Subjects who have mental or physical disability;
  • Subjects who have any surgical and medical conditions, which might be harmful if subjects participate in the study, or which might change the absorption, distribution, metabolism and excretion of investigational medication;
  • Heart beat rate <50 beats /min or >100 beats /min (heart rates should be measured after a brief period of rest, at least 5 minutes.), systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg, body temperature (forehead)>37.6℃;
  • Hgb < LLN (lower limit of normal), the absolute neutrophil count (ANC) <1.5×10^9/L, platelets <100×10^9/L; bilirubin > ULN (upper limit of normal), serum creatinine > ULN ; glutamic oxaloacetic transaminase (AST) > ULN, glutamic pyruvic transaminase (ALT) > ULN;
  • Subject who have active infection, or positive for hepatitis-B surface antigen (HBs-Ag), hepatitis-C antibody (HCV-Ab), or HIV-Ab;
  • Positive urinalysis for protein, or other abnormal urinalysis tests which were judged to have clinical significance by investigators;
  • History of drug allergy, postural hypotension, or idiopathic allergy;
  • Prior exposure to abatacept (CTLA4-Ig), belatacept (LEA29Y) or any leukocyte depleting agent;
  • Use of any prescription drugs within 4 weeks (or 5 half-lives, whichever is longer) prior to enrollment, Use of any OTC medications and herbal preparations within 1 week prior to enrollment, unless the medical monitoring shows that the drug has been cleared;
  • Vaccination with any live vaccine within 4 weeks prior to study medication administration on Day 1;
  • Administration of oral polio vaccine to subject or house hold contacts during the course of study;
  • Prisoners or subjects who are involuntarily incarcerated;
  • Subjects who are compulsorily detained for treatment either a psychiatric or physical (e.g., infectious disease) illness.

About this study

Official 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

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.

Being tested
Abatacept, Placebo
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbataceptDrug

    Also called Orencia

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

  • PlaceboOther

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

Study groups in NCT02805010
Study groupRoleWhat they receive
Subcutaneous(SC) AbataceptExperimentalNot described
Receives: Drug: Abatacept
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Plasma Concentration (Cmax)

    Measured: Day1 to Day71

  2. Area Under the Curve (AUC)

    Measured: Day1 to Day71

  3. Half-life period (T1/2)

    Measured: Day1 to Day71

  4. Time to peak (Tmax)

    Measured: Day1 to Day71

Secondary outcomes (3)

  1. Adverse event (AE)

    Measured: Signed Informed consent form (ICF) to Day 71

  2. anti-abatacept antibodies

    Measured: Day1 to Day 71

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

    Measured: Day1 to Day 71

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionFeb 2017 (estimated)
  4. Study completionFeb 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02805010
Sponsor's protocol ID
SIM-126-I
Status last verified
Nov 2016
First submitted
12 Jun 2016
Last updated
6 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Abatacept in people with Rheumatoid Arthritis (RA), run by Jiangsu Simcere Pharmaceutical Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Plasma Concentration (Cmax) (time frame: Day1 to Day71). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02805010.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016.

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