Healthy ParticipantsPhase 1NCT04439929
Comparative Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of Adalimumab in Healthy Subjects
A Phase 1 study testing TUR01 and Adalimumab-EU in people with Healthy Participants, run by Turgut İlaçları A.Ş. at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- TUR01 and Adalimumab-EU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteGermany
- Study dates
- 17 Jul 2019to 16 Jan 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
PAREXEL International GmbH, Early Phase Clinical Unit Berlin
Berlin, 14050
About this study
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
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
- Being tested
- TUR01, Adalimumab-EU
- Keywords
- adalimumab, biosimilar, healthy, phase 1, pharmacokinetics, bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TUR01Biological
Also called Adalimumab-Turgut
Administered as a single 40 mg, subcutaneous dose
Adalimumab-EUBiological
Also called Humira
Administered as a single 40 mg, subcutaneous dose
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab-TUR01 | Experimental | Not described Receives: Biological: TUR01 |
| Adalimumab-EU | Active comparator | Not described Receives: Biological: Adalimumab-EU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 1 - Day 71
Maximum serum concentration (Cmax)
Cmax
Measured: Day 1 - Day 71
Secondary outcomes (11)
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast)
Measured: Day 1 - Day 71
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
Measured: Day 1 - Day 15
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
Measured: Day 1 - Day 29
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
Measured: Day 1 - Day 43
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
Measured: Day 1 - Day 71
Time to Cmax (Tmax)
Time to reach the maximum concentration
Measured: Day 1 - Day 71
Apparent volume of distribution based on the terminal phase (Vz/F)
Measured: Day 1 - Day 71
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
Measured: Day 1 - Day 71
Terminal half-life calculated by ln(2)/λz (t½)
Measured: Day 1 - Day 71
Apparent total body clearance (CL/F)
Measured: Day 1 - Day 71
Area under the concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCextrap)
Measured: Day 1 - Day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start17 Jul 2019
- Primary completion16 Jan 2020
- Study completion16 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turgut İlaçları A.Ş.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rainard Fuhr, Principal investigator, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439929
- Sponsor's protocol ID
- 240648
- Status last verified
- Jun 2020
- First submitted
- 15 Jun 2020
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04439929
- Acronym / sponsor ID
- 240648
- Conditions
- Healthy Participants
- Keywords
- adalimumab, biosimilar, healthy, phase 1, pharmacokinetics, bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Turgut İlaçları A.Ş.Industry (pharma, biotech, devices)
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 16 Jan 2020 (actual)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adalimumab-TUR01 | Experimental | Biological: TUR01 |
| Adalimumab-EU | Active comparator | Biological: Adalimumab-EU |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TUR01Also: Adalimumab-TurgutAdministered as a single 40 mg, subcutaneous dose | Biological | Adalimumab-TUR01 |
| Adalimumab-EUAlso: HumiraAdministered as a single 40 mg, subcutaneous dose | Biological | Adalimumab-EU |
Primary outcome
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
11 secondary outcomes
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 672 hours (AUC672)
Time frame: Day 1 - Day 29
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 1680 hours (AUC1680)
Time frame: Day 1 - Day 71
Time to Cmax (Tmax)
Time frame: Day 1 - Day 71
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainard Fuhr principal investigator
Parexel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TUR01 and Adalimumab-EU in people with Healthy Participants, run by Turgut İlaçları A.Ş. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration-time curve from time 0 to infinity (AUCinf) (time frame: Day 1 - Day 71). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2020.