Healthy Participants
Conditions
Keywords
adalimumab, biosimilar, healthy, phase 1, pharmacokinetics, bioequivalence
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.
Interventions
BIOLOGICALTUR01
Administered as a single 40 mg, subcutaneous dose
BIOLOGICALAdalimumab-EU
Administered as a single 40 mg, subcutaneous dose
Sponsors
Turgut İlaçları A.Ş.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 from time zero to 1008 hours (AUC1008) | 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) | Day 1 - Day 71 | Area under the concentration-time curve from time zero to 70 days |
| 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 |
| Terminal half-life calculated by ln(2)/λz (t½) | Day 1 - Day 71 | — |
| Apparent total body clearance (CL/F) | Day 1 - Day 71 | — |
| Area under the concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCextrap) | Day 1 - Day 71 | — |
| Time to Cmax (Tmax) | Day 1 - Day 71 | Time to reach the maximum concentration |
| Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast) | Day 1 - Day 71 | — |
Other
| Measure | Time frame |
|---|---|
| Immunogenicity - Incidence of anti-drug antibodies to adalimumab | Day 1 - Day 71 |
| Immunogenicity - Incidence of neutralizing antibodies | Day 1 - Day 71 |
Countries
Germany
Outcome results
None listed