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CompletedNCT04439929Updated Jun 19, 2020

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

A Phase 1 interventional study of TUR01 and Adalimumab-EU in Healthy Participants, sponsored by Turgut İlaçları A.Ş.. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-19.

Sponsored by Turgut İlaçları A.Ş. · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jul 2019, registered Jun 2020).
Phase
Phase 1
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Participants

Keywords

  • adalimumab
  • biosimilar
  • healthy
  • phase 1
  • pharmacokinetics
  • bioequivalence
03

In context

Lead sponsor

This is the only study on the registry with Turgut İlaçları A.Ş. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
168 participants (actual)

Study arms

  • Experimental
    Adalimumab-TUR01

    Biological: TUR01

  • Active comparator
    Adalimumab-EU

    Biological: Adalimumab-EU

Interventions

  • BiologicalTUR01

    Administered as a single 40 mg, subcutaneous dose

    Also known as: Adalimumab-Turgut

  • BiologicalAdalimumab-EU

    Administered as a single 40 mg, subcutaneous dose

    Also known as: Humira

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Day 1 - Day 71

  2. Maximum serum concentration (Cmax)

    Cmax

    Time frame: Day 1 - Day 71

Secondary outcomes

  1. Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast)

    Time frame: Day 1 - Day 71

  2. Area under the concentration-time curve from time zero to 336 hours (AUC336)

    Area under the concentration-time curve from time zero to 14 days

    Time frame: Day 1 - Day 15

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

    Area under the concentration-time curve from time zero to 28 days

    Time frame: Day 1 - Day 29

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

    Area under the concentration-time curve from time zero to 42 days

    Time frame: Day 1 - Day 43

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

    Area under the concentration-time curve from time zero to 70 days

    Time frame: Day 1 - Day 71

  6. Time to Cmax (Tmax)

    Time to reach the maximum concentration

    Time frame: Day 1 - Day 71

  7. Apparent volume of distribution based on the terminal phase (Vz/F)

    Time frame: Day 1 - Day 71

  8. Terminal rate constant (λz)

    The parameter will be calculated by linear least squares regression analysis using at least 3 non-zero concentrations in the terminal phase

    Time frame: Day 1 - Day 71

  9. Terminal half-life calculated by ln(2)/λz (t½)

    Time frame: Day 1 - Day 71

  10. Apparent total body clearance (CL/F)

    Time frame: Day 1 - Day 71

  11. 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

Other outcomes

  1. Immunogenicity - Incidence of anti-drug antibodies to adalimumab

    Time frame: Day 1 - Day 71

  2. Immunogenicity - Incidence of neutralizing antibodies

    Time frame: Day 1 - Day 71

07

Study locations

1 site
  • PAREXEL International GmbH, Early Phase Clinical Unit Berlin
    Berlin, 14050, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04439929
Lead sponsor
Turgut İlaçları A.Ş.
Responsible party
Sponsor
First posted
Jun 19, 2020
Start date
Jul 17, 2019
Primary completion
Jan 16, 2020
Completion
Jan 16, 2020
Last update
Jun 19, 2020

Study contacts

Rainard Fuhr
principal investigator · Parexel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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