Bioequivalence Clinical Trial
Official title:
A Randomised, Double-blind, Single-dose, Parallel-group Study in Healthy Subjects to Demonstrate Pharmacokinetic Equivalence of CinnoRA® (Produced by CinnaGen CO.) and Humira® (the Reference Drug, Produced by AbbVie Inc.)
Verified date | September 2018 |
Source | Cinnagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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®.
Status | Completed |
Enrollment | 74 |
Est. completion date | August 6, 2017 |
Est. primary completion date | August 6, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Orchidpharmed PK/PD site | Tehran |
Lead Sponsor | Collaborator |
---|---|
Cinnagen |
Iran, Islamic Republic of,
Davatchi F, Jamshidi AR, Banihashemi AT, Gholami J, Forouzanfar MH, Akhlaghi M, Barghamdi M, Noorolahzadeh E, Khabazi AR, Salesi M, Salari AH, Karimifar M, Essalat-Manesh K, Hajialiloo M, Soroosh M, Farzad F, Moussavi HR, Samadi F, Ghaznavi K, Asgharifard H, Zangiabadi AH, Shahram F, Nadji A, Akbarian M, Gharibdoost F. WHO-ILAR COPCORD Study (Stage 1, Urban Study) in Iran. J Rheumatol. 2008 Jul;35(7):1384. Epub 2008 May 1. — View Citation
Hyland E, Mant T, Vlachos P, Attkins N, Ullmann M, Roy S, Wagner V. Comparison of the pharmacokinetics, safety, and immunogenicity of MSB11022, a biosimilar of adalimumab, with Humira(®) in healthy subjects. Br J Clin Pharmacol. 2016 Oct;82(4):983-93. doi: 10.1111/bcp.13039. Epub 2016 Jul 28. — View Citation
Kaur P, Chow V, Zhang N, Moxness M, Kaliyaperumal A, Markus R. A randomised, single-blind, single-dose, three-arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab. Ann Rheum Dis. 2017 Mar;76(3):526-533. doi: 10.1136/annrheumdis-2015-208914. Epub 2016 Jul 27. — View Citation
Ma VY, Chan L, Carruthers KJ. Incidence, prevalence, costs, and impact on disability of common conditions requiring rehabilitation in the United States: stroke, spinal cord injury, traumatic brain injury, multiple sclerosis, osteoarthritis, rheumatoid arthritis, limb loss, and back pain. Arch Phys Med Rehabil. 2014 May;95(5):986-995.e1. doi: 10.1016/j.apmr.2013.10.032. Epub 2014 Jan 21. Review. — View Citation
Wiens A, Correr CJ, Venson R, Otuki MF, Pontarolo R. A systematic review and meta-analysis of the efficacy and safety of adalimumab for treating rheumatoid arthritis. Rheumatol Int. 2010 Jun;30(8):1063-70. doi: 10.1007/s00296-009-1111-4. Epub 2009 Aug 26. Review. — View Citation
Wong M, Ziring D, Korin Y, Desai S, Kim S, Lin J, Gjertson D, Braun J, Reed E, Singh RR. TNFalpha blockade in human diseases: mechanisms and future directions. Clin Immunol. 2008 Feb;126(2):121-36. Epub 2007 Oct 3. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area under the concentration-time curve from time zero to infinity (AUCinf) | AUCinf will be calculated using the equation:AUCinf= AUClast + (Clast / Kel) | 71 days | |
Primary | Maximum serum concentration (Cmax) | It is obtained directly from the observed concentration-time data | 71 days | |
Secondary | Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast) | It is calculated using the linear trapezoidal rule | 71 days | |
Secondary | Time to Cmax (Tmax) | It is obtained directly from the observed concentration-time data | 71 days |
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