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

NCT ID: NCT04439929

Last Updated: 2020-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-17
• Study Completion Date: 2020-01-16

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Adalimumab-TUR01

Group Type: EXPERIMENTAL

TUR01

Intervention Type: BIOLOGICAL

Administered as a single 40 mg, subcutaneous dose

Adalimumab-EU

Group Type: ACTIVE_COMPARATOR

Adalimumab-EU

Intervention Type: BIOLOGICAL

Administered as a single 40 mg, subcutaneous dose

Interventions

TUR01

Administered as a single 40 mg, subcutaneous dose

Intervention Type: BIOLOGICAL

Adalimumab-EU

Administered as a single 40 mg, subcutaneous dose

Intervention Type: BIOLOGICAL

Other Intervention Names

Adalimumab-Turgut; Humira

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Turgut İlaçları A.Ş.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rainard Fuhr

Role: PRINCIPAL_INVESTIGATOR

Parexel

Locations

PAREXEL International GmbH, Early Phase Clinical Unit Berlin

Berlin, , Germany

Countries

Germany

Other Identifiers

240648

Identifier Type: -

Identifier Source: org_study_id