A Randomized, Double-blind, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of Adalimumab (TUR01 and EU Sourced Humira®) in Healthy Subjects

Turgut İlaçları A.Ş.1 site in 1 country168 target enrollmentJuly 17, 2019

ConditionsHealthy Participants

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy Participants
Sponsor: Turgut İlaçları A.Ş.
Enrollment: 168
Locations: 1
Primary Endpoint: Area under the concentration-time curve from time 0 to infinity (AUCinf)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

July 17, 2019

End Date

January 16, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Turgut İlaçları A.Ş.

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Area under the concentration-time curve from time 0 to infinity (AUCinf)

Time Frame: Day 1 - Day 71

AUCinf = area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast) + last observed concentration (Ct)/terminal rate constant (λz)

Maximum serum concentration (Cmax)

Time Frame: Day 1 - Day 71

Cmax

Secondary Outcomes

Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast)(Day 1 - Day 71)
Area under the concentration-time curve from time zero to 336 hours (AUC336)(Day 1 - Day 15)
Time to Cmax (Tmax)(Day 1 - Day 71)
Terminal half-life calculated by ln(2)/λz (t½)(Day 1 - Day 71)
Area under the concentration-time curve from time zero to 1680 hours (AUC1680)(Day 1 - Day 71)
Apparent total body clearance (CL/F)(Day 1 - Day 71)
Apparent volume of distribution based on the terminal phase (Vz/F)(Day 1 - Day 71)
Terminal rate constant (λz)(Day 1 - Day 71)
Area under the concentration-time curve from time zero to 672 hours (AUC672)(Day 1 - Day 29)
Area under the concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCextrap)(Day 1 - Day 71)
Area under the concentration-time curve from time zero to 1008 hours (AUC1008)(Day 1 - Day 43)