Status:
COMPLETED
Comparative Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of Adalimumab in Healthy Subjects
Lead Sponsor:
Turgut İlaçları A.Ş.
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a randomized, double-blind, two-arm, parallel group, single-dose study to demonstrate pharmacokinetic, safety, tolerability and immunogenicity similarity of biosimilar candidate TUR01 to EU-so...
Eligibility Criteria
Inclusion
- Healthy female subjects of non-childbearing potential or healthy male subjects aged 18 to 55 years (inclusive at screening).
- Have body weight between 65.0 to 90.0 kg and a body mass index between 20.0 to 29.9 kg/m2, inclusive.
- Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Must be able to provide written informed consent, which must be obtained prior to any study related procedures.
Exclusion
- Evidence or history of clinically significant or relevant pathology.
- Have either active or latent tuberculosis.
- Have received treatment with a monoclonal antibody or fusion protein within 9 months prior to administration and/or have evidence of immunogenicity from previous exposure to a monoclonal antibody or fusion protein.
- Have a mental disease classified as serious by the Investigator.
- 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.
- Who intake alcoholic beverages more than 28 units per week.
- Have taken medication with a half-life of \> 24 h within 4 weeks or 10 half-lives of the medication prior to investigational medicinal product administration.
- Have donated \> 100 mL of blood or plasma within 4 weeks prior to investigational medicinal product administration.
- Have participated in another study with an investigational drug within 4 weeks prior to investigational medicinal product administration. Subjects who have received treatment with a biological or immunosuppressive agent within 3 months of screening should also be excluded.
- Subjects who are not able to consume standardized meals provided by the clinical study site during hospitalization.
- Subjects who, in the opinion of the Investigator, are not likely to complete the study for whatever reason.
- Involvement of any sponsor, study site/contract research organisation employee, Investigator or their close relatives.
- Vulnerable subjects.
- Pregnant or nursing women.
Key Trial Info
Start Date :
July 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2020
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT04439929
Start Date
July 17 2019
End Date
January 16 2020
Last Update
June 19 2020
Active Locations (1)
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1
PAREXEL International GmbH, Early Phase Clinical Unit Berlin
Berlin, Germany, 14050