Comparative Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of Adalimumab in Healthy Subjects

Turgut İlaçları

Status and phase

Completed

Phase 1

Conditions

Healthy Participants

Treatments

Biological: Adalimumab-EU

Biological: TUR01

Study type

Interventional

Funder types

Industry

Identifiers

NCT04439929

240648

Details and patient eligibility

About

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-sourced Humira® in healthy participants after administration of adalimumab.

Enrollment

168 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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.