Study to Compare PK & Safety of Advixa With Humira in Healthy, Adult Subject Followed by Efficacy & Safety Study in RA Patients (ACT)
Pharmacokinetics, Safety, Efficacy
About this trial
This is an interventional treatment trial for Pharmacokinetics
Eligibility Criteria
Inclusion Criteria:
- Eligibility of ages for Study: ≥ 18 Years to ≤ 45 Years
- Genders Eligible for Study: Both
- Subjects who are able and willing to give written informed consent
- Willing and able to comply with the requirements of the protocol and be available for the planned duration of the study.
d. Have Chest X ray with no evidence of current active TB or previous (inactive) TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or prior to study and read by a qualified radiologist.
e. Female patients of childbearing potential have to have a negative pregnancy test at the time of screening and agreed to use adequate contraception throughout the study period.
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic (Multiple sclerosis), autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin.
- Active or latent Tuberculosis or who have a history of Tuberculosis
- History of invasive systemic fungal infections or other opportunistic infections
- Systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process
- Serious infection associated with hospitalization and/or which required intravenous antibiotics
- History of and/or current cardiac disease or moderate to severe heart failure (NYHA class III/IV).
- Have received live vaccine(s) within 4 weeks prior to Screening or who will require live vaccine(s) between Screening and the final study visit
- Intake medication with a half-life > 24 h within 4 weeks or 5 half-lives of the medication prior to investigational product administration
- Hypersensitivity to the active substance or to any of the excipients (Mannitol and Polysorbate 80)
- History of severe allergic or anaphylactic reactions to latex
- History of alcohol, drug, or chemical abuse within 6 months prior to screening
- History of chronic daily use of narcotic analgesics.
Sites / Locations
- ideSHiRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Advixa
Humira
Generic name: Adalimumab Dosage form: Injectable Route of Administration: Subcutaneous Dosage: 40mg/0.4mL Frequency: Once in 2 weeks Duration: Single dose for Phase 2 and 3 months for Phase 3
Generic name: Adalimumab Dosage form: Injectable Route of Administration: Subcutaneous Dosage: 40mg/0.4mL Frequency: Once in 2 weeks Duration: Single dose for Phase 2 and 3 months for Phase 3