Clinical trial NCT04439929: Comparative Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of Adalimumab in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: adalimumab
biosimilar
healthy
phase 1
pharmacokinetics
bioequivalence
Lead sponsor: Turgut İlaçları A.Ş.
Sponsor class: INDUSTRY
First posted: 2020-06-19
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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.
* 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.

Primary outcomes:
measure: Area under the concentration-time curve from time 0 to infinity (AUCinf)
timeFrame: Day 1 - Day 71
measure: Maximum serum concentration (Cmax)
timeFrame: Day 1 - Day 71
Secondary outcomes:
measure: Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast)
timeFrame: Day 1 - Day 71
measure: Area under the concentration-time curve from time zero to 336 hours (AUC336)
timeFrame: Day 1 - Day 15
measure: Area under the concentration-time curve from time zero to 672 hours (AUC672)
timeFrame: Day 1 - Day 29
measure: Area under the concentration-time curve from time zero to 1008 hours (AUC1008)
timeFrame: Day 1 - Day 43
measure: Area under the concentration-time curve from time zero to 1680 hours (AUC1680)
timeFrame: Day 1 - Day 71
measure: Time to Cmax (Tmax)
timeFrame: Day 1 - Day 71
measure: Apparent volume of distribution based on the terminal phase (Vz/F)
timeFrame: Day 1 - Day 71
measure: Terminal rate constant (λz)
timeFrame: Day 1 - Day 71
measure: Terminal half-life calculated by ln(2)/λz (t½)
timeFrame: Day 1 - Day 71
measure: Apparent total body clearance (CL/F)
timeFrame: Day 1 - Day 71
measure: Area under the concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCextrap)
timeFrame: Day 1 - Day 71
Other outcomes:
measure: Immunogenicity - Incidence of anti-drug antibodies to adalimumab
timeFrame: Day 1 - Day 71
measure: Immunogenicity - Incidence of neutralizing antibodies
timeFrame: Day 1 - Day 71
Locations:
city: Berlin
country: Germany
facility: PAREXEL International GmbH, Early Phase Clinical Unit Berlin
Study officials:
affiliation: Parexel
name: Rainard Fuhr
role: PRINCIPAL_INVESTIGATOR
References: