Comparative Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of Adalimumab in Healthy Subjects
- Conditions
- Healthy Participants
- Interventions
- Biological: TUR01Biological: Adalimumab-EU
- Registration Number
- NCT04439929
- Lead Sponsor
- Turgut İlaçları A.Ş.
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 168
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adalimumab-TUR01 TUR01 - Adalimumab-EU Adalimumab-EU -
- Primary Outcome Measures
Name Time Method Area under the concentration-time curve from time 0 to infinity (AUCinf) 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) Day 1 - Day 71 Cmax
- Secondary Outcome Measures
Name Time Method 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 14 days
Time to Cmax (Tmax) Day 1 - Day 71 Time to reach the maximum concentration
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 Area under the concentration-time curve from time zero to 70 days
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 The parameter will be calculated by linear least squares regression analysis using at least 3 non-zero concentrations in the terminal phase
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 28 days
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 Area under the concentration-time curve from time zero to 42 days
Trial Locations
- Locations (1)
PAREXEL International GmbH, Early Phase Clinical Unit Berlin
🇩🇪Berlin, Germany