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

NCT04439929 | Completed Phase 1

• 1 other identifier: 240648
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

adalimumab; biosimilar; healthy; phase 1; pharmacokinetics; bioequivalence

Outcome Measures

Primary Outcomes (2)

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

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

  Day 1 - Day 71

• Maximum serum concentration (Cmax)

  Cmax

  Day 1 - Day 71

Secondary Outcomes (11)

• 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

• Area under the concentration-time curve from time zero to 672 hours (AUC672)

  Day 1 - Day 29

• Area under the concentration-time curve from time zero to 1008 hours (AUC1008)

  Day 1 - Day 43

• Area under the concentration-time curve from time zero to 1680 hours (AUC1680)

  Day 1 - Day 71

Other Outcomes (2)

• Immunogenicity - Incidence of anti-drug antibodies to adalimumab

  Day 1 - Day 71

• Immunogenicity - Incidence of neutralizing antibodies

  Day 1 - Day 71

Study Arms (2)

Adalimumab-TUR01

EXPERIMENTAL

Biological: TUR01

Adalimumab-EU

ACTIVE COMPARATOR

Biological: Adalimumab-EU

Interventions

TUR01 BIOLOGICAL

Administered as a single 40 mg, subcutaneous dose

Also known as: Adalimumab-Turgut

Adalimumab-TUR01

Adalimumab-EU BIOLOGICAL

Administered as a single 40 mg, subcutaneous dose

Also known as: Humira

Adalimumab-EU

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Turgut İlaçları A.Ş.: lead

Study Sites (1)

PAREXEL International GmbH, Early Phase Clinical Unit Berlin

Berlin, 14050, Germany

Location

MeSH Terms

Interventions

Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Rainard Fuhr

  Parexel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 19, 2020
• Study Start: July 17, 2019
• Primary Completion: January 16, 2020
• Study Completion: January 16, 2020
• Last Updated: June 19, 2020

Record last verified: 2020-06

Locations

DE (1)