History of Changes for Study: NCT04439929

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

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Version	A	B	Submitted Date	Changes
1			June 17, 2020	None (earliest Version on record)

Study Identification


Unique Protocol ID:	240648
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
Secondary IDs:

Study Status


Record Verification:	June 2020
Overall Status:	Completed
Study Start:	July 17, 2019
Primary Completion:	January 16, 2020 [Actual]
Study Completion:	January 16, 2020 [Actual]

First Submitted:	June 15, 2020
First Submitted that Met QC Criteria:	June 17, 2020
First Posted:	June 19, 2020 [Actual]

Last Update Submitted that Met QC Criteria:	June 17, 2020
Last Update Posted:	June 19, 2020 [Actual]

Sponsor/Collaborators


Sponsor:	Turgut İlaçları A.Ş.
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description


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:

Conditions


Conditions:	Healthy Participants
Keywords:	adalimumab biosimilar healthy phase 1 pharmacokinetics bioequivalence

Study Design


Study Type:	Interventional
Primary Purpose:	Basic Science
Study Phase:	Phase 1
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Double (Participant, Investigator)
Allocation:	Randomized
Enrollment:	168 [Actual]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Adalimumab-TUR01	Biological: TUR01 Administered as a single 40 mg, subcutaneous dose Other Names: Adalimumab-Turgut
Active Comparator: Adalimumab-EU	Biological: Adalimumab-EU Administered as a single 40 mg, subcutaneous dose Other Names: Humira

Outcome Measures


Primary Outcome Measures:
1.	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)
2.	Maximum serum concentration (Cmax) [ Time Frame: Day 1 - Day 71 ] Cmax
Secondary Outcome Measures:
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) [ Time Frame: Day 1 - Day 15 ] Area under the concentration-time curve from time zero to 14 days
3.	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
4.	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
5.	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
6.	Time to Cmax (Tmax) [ Time Frame: Day 1 - Day 71 ] Time to reach the maximum concentration
7.	Apparent volume of distribution based on the terminal phase (Vz/F) [ Time Frame: Day 1 - Day 71 ]
8.	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
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 Outcome Measures:
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 ]

Eligibility


Minimum Age:	18 Years
Maximum Age:	55 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
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.

Contacts/Locations


Study Officials:	Rainard Fuhr Principal Investigator Parexel
Locations:	Germany
	PAREXEL International GmbH, Early Phase Clinical Unit Berlin Berlin, Germany, 14050

IPDSharing


Plan to Share IPD:

References


Citations:
Links:
Available IPD/Information: