A Study to Evaluate the Pharmacokinetics of Abatacept Converted From Drug Substance by Two Different Processes
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Abatacept
Intervention description: Participants will receive abatacept at a single dose 750 mg as IV infusion.
Intervention MeSH terms: Abatacept
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main objective of this study is to compare the pharmacokinetics (PK) of the abatacept
      drug product converted from drug substance by a new drug substance process (Treatment A)
      relative to the current drug substance process (Treatment B) following a single dose (750 mg)
      intravenous (IV) infusion in healthy participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body weight will be between 60 and 100 kg, inclusive.

          -  Women of childbearing potential (WOCBP) must have a negative serum pregnancy test
             within 24 hours prior to the start of study treatment.

          -  Women must not be breastfeeding.

          -  WOCBP must agree to follow instructions for method(s) of contraception for the
             duration of treatment with abatacept plus 5 half-lives of abatacept (85 days) plus 30
             days (duration of ovulatory cycle) for a total of 115 days post-treatment completion.

          -  Males who are sexually active with WOCBP must agree to follow instructions for
             method(s) of contraception for the duration of treatment with abatacept plus 5
             half-lives of abatacept (85 days) plus the duration of spermatogenesis (90 days) for a
             total of 175 days after the last dose of study treatment. In addition, male
             participants must be willing to refrain from sperm donation during this time.

        Exclusion Criteria:

          -  Participants who have a present malignancy or previous malignancy within the last 5
             years prior to screening (except documented history of cured non-metastatic squamous
             or basal cell skin carcinoma or cervical carcinoma in situ). Participants who had a
             screening procedure that is suspicious for malignancy, and in whom the possibility of
             malignancy cannot be reasonably excluded following additional clinical, laboratory or
             other diagnostic evaluations.

          -  Participants with a history of herpes zoster.

          -  Donation of blood to a blood bank or in a clinical study (except a screening visit or
             follow-up visit) within 4 weeks of study treatment administration (within 2 weeks of
             study treatment administration for plasma only).

          -  Blood transfusion within 4 weeks of study treatment administration.

          -  Recent (within 6 months of study treatment administration) history of smoking or
             current smokers. This includes participants using electronic cigarettes or
             nicotine-containing products such as tobacco for chewing, nicotine patches, nicotine
             lozenges, or nicotine gum.

          -  History of allergy to abatacept or related compounds.