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

• ClinicalTrials.gov Identifier: NCT04439929
• Recruitment Status: Completed
• First Posted: June 19, 2020
• Last Update Posted: June 19, 2020
• Sponsor: Turgut İlaçları A.Ş.
• Information provided by (Responsible Party): Turgut İlaçları A.Ş.

Tracking Information

• First Submitted Date: June 15, 2020
• First Posted Date: June 19, 2020
• Last Update Posted Date: June 19, 2020
• Actual Study Start Date: July 17, 2019
• Actual Primary Completion Date: January 16, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 17, 2020)

• 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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: June 17, 2020)

• Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast) [ Time Frame: Day 1 - Day 71 ]
• Area under the concentration-time curve from time zero to 336 hours (AUC336) [ Time Frame: Day 1 - Day 15 ]
  Area under the concentration-time curve from time zero to 14 days
• Area under the concentration-time curve from time zero to 672 hours (AUC672) [ Time Frame: Day 1 - Day 29 ]
  Area under the concentration-time curve from time zero to 28 days
• Area under the concentration-time curve from time zero to 1008 hours (AUC1008) [ Time Frame: Day 1 - Day 43 ]
  Area under the concentration-time curve from time zero to 42 days
• Area under the concentration-time curve from time zero to 1680 hours (AUC1680) [ Time Frame: Day 1 - Day 71 ]
  Area under the concentration-time curve from time zero to 70 days
• Time to Cmax (Tmax) [ Time Frame: Day 1 - Day 71 ]
  Time to reach the maximum concentration
• Apparent volume of distribution based on the terminal phase (Vz/F) [ Time Frame: Day 1 - Day 71 ]
• Terminal rate constant (λz) [ Time Frame: Day 1 - Day 71 ]
  The parameter will be calculated by linear least squares regression analysis using at least 3 non-zero concentrations in the terminal phase
• Terminal half-life calculated by ln(2)/λz (t½) [ Time Frame: Day 1 - Day 71 ]
• Apparent total body clearance (CL/F) [ Time Frame: Day 1 - Day 71 ]
• Area under the concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCextrap) [ Time Frame: Day 1 - Day 71 ]

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: June 17, 2020)

• Immunogenicity - Incidence of anti-drug antibodies to adalimumab [ Time Frame: Day 1 - Day 71 ]
• Immunogenicity - Incidence of neutralizing antibodies [ Time Frame: Day 1 - Day 71 ]

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science
• Condition: Healthy Participants

Intervention

• Biological: TUR01
  Administered as a single 40 mg, subcutaneous dose
  Other Name: Adalimumab-Turgut
• Biological: Adalimumab-EU
  Administered as a single 40 mg, subcutaneous dose
  Other Name: Humira

Study Arms

• Experimental: Adalimumab-TUR01
  Intervention: Biological: TUR01
• Active Comparator: Adalimumab-EU
  Intervention: Biological: Adalimumab-EU

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 17, 2020): 168
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 16, 2020
• Actual Primary Completion Date: January 16, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT04439929
• Other Study ID Numbers: 240648
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Turgut İlaçları A.Ş.
• Original Responsible Party: Same as current
• Current Study Sponsor: Turgut İlaçları A.Ş.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Rainard Fuhr; Parexel

• PRS Account: Turgut İlaçları A.Ş.
• Verification Date: June 2020