A Study Of CinnoRA (Adalimumab-CinnaGen) And Adalimumab (Humira) In Healthy Subjects

• Status: Completed
• Trial end date: 2017-08-06
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to demonstrate pharmacokinetic (PK) similarity of biosimilar candidate CinnoRA® relative to adalimumab reference product (Humira®) and evaluate safety and tolerability of CinnoRA®, in a parallel fashion in healthy volunteers after administration of a single dose (40 mg) of adalimumab.

The primary objective of this study is to demonstrate that the PK of CinnoRA® is similar to its originator, Humira®, as assessed by the area under the serum concentration time curve (AUC) from time 0 extrapolated to infinity (AUCinf) and the Cmax.

The secondary objectives of the study are:

• To further compare the PK of CinnoRA® and Humira®.

• To assess the safety of CinnoRA®.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cinnagen
• Treatments: Adalimumab

Criteria

Inclusion Criteria:

1. Provide signed ICF to participate in the trial and to comply with the trial procedures.

2. Be healthy male and female between the ages of 18 and 45 years. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests.

3. Have a Body Mass Index (BMI) of 19.0 to 30.5 kg/m2;

4. 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 within 24 weeks prior to Day 1 and read by a qualified radiologist.

5. Female subjects with child-bearing potential must agree to use a medically accepted method of contraception during the trial and one month after the end of the trial. Acceptable methods of contraception include the following:

• Stable oral/transdermal/injectable hormonal contraceptive regimen without break through uterine bleeding and condom/spermicide.

• Intrauterine device (inserted at least 2 months prior to screening visit) used with spermicide/condom.

• Condom (male or female) with spermicide

• Vasectomy of the male partner in conjunction with condom or spermicide.

Exclusion Criteria:

1. Being doubtful about their availability to complete the trial.

2. 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).

3. Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin.

4. Active or latent Tuberculosis or who have a history of Tuberculosis

5. History of invasive systemic fungal infections or other opportunistic infections

6. Systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process

7. Serious infection associated with hospitalisation and/or which required intravenous antibiotics

8. History of and/or current cardiac disease

9. 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

10. Intake medication with a half-life > 24 h within 4 weeks or 5 half-lives of the medication prior to investigational product administration

11. Have a history of smoking >10 cigarettes per day.