Study to Determine the Pharmacokinetic (PK) Bioequivalence of ABP 501 and Adalimumab (Humira®) in Healthy Adult Japanese Participants

NCT05995691 | Completed Phase 1 FDA Drug

• 1 other identifier: 20120176
• Study Type: interventional
• Target: 179
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to determine the bioequivalence of ABP 501 (subcutaneous \[SC\] injection) compared to adalimumab (SC injection) as assessed principally by the area under the serum concentration-time curve from time 0 extrapolated to infinity (AUCinf), and maximum observed serum concentration (Cmax) in Japanese participants.

Conditions

Healthy Volunteers

Keywords

ABP 501; Adalimumab; Humira®

Outcome Measures

Primary Outcomes (4)

• AUCinf of ABP 501

  Day 1 to Day 63

• Cmax of ABP 501

  Day 1 to Day 63

• AUCinf of Adalimumab

  Day 1 to Day 63

• Cmax of Adalimumab

  Day 1 to Day 63

Secondary Outcomes (8)

• Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

  Day 1 to Day 63

• Number of Participants With Anti-drug Antibodies (ADA)

  Day 1 to Day 63

• Terminal Phase Elimination Half-life (t1/2) of ABP 501

  Day 1 to Day 63

• t1/2 of Adalimumab

  Day 1 to Day 63

• Time at Which the Maximum Observed Serum Concentration is Observed (Tmax) of ABP 501

  Day 1 to Day 63

Study Arms (2)

ABP 501

EXPERIMENTAL

Participants will receive a single dose of ABP 501

Drug: ABP 501

Adalimumab

ACTIVE COMPARATOR

Participants will receive a single dose of adalimumab

Drug: Adalimumab

Interventions

ABP 501 DRUG

SC injection

ABP 501

Adalimumab DRUG

SC injection

Also known as: Humira®

Adalimumab

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved ICF before any study-specific procedures are performed.
• Healthy adult male and female Japanese participants between 18 and 45 years of age, inclusive, at the time of screening.
• Body mass index (BMI) between 16.0 and 25.0 kg/m2, inclusive, at screening and Day -1.
• Normal or clinically acceptable physical examination, clinical laboratory test values, vital signs, and electrocardiogram (ECG) (12-lead ECG reporting heart rate and RR, PR, QRS, QT, and QTc intervals), as determined by the investigator, at screening. Physical examination, vital signs, body weight and BMI, clinical laboratory tests, pregnancy test, urinalysis, urine drug screen, and alcohol screen will be repeated on Day -1 (see Table 2-1) and must also be normal or clinically acceptable, as deemed by the investigator.
• Participants must be current on immunizations per local standards.
• Participants must be first- or second-generation Japanese:
• First-generation Japanese are participants who may be living outside of Japan but were born in Japan to parents of Japanese descent
• Second-generation Japanese are participants who were born outside of Japan to first-generation Japanese parents

You may not qualify if:

• Women of childbearing potential who are unwilling to practice a highly effective method of birth control for the duration of the study and for 5 months following treatment with the investigational product or until the scheduled end-of-study (EOS) (whichever is longer). Acceptable methods of effective birth control include:
• Abstinence
• Surgical methods: bilateral tubal ligation or vasectomy for the male sexual partner
• Hormonal methods
• Intrauterine device (IUD)
• Two barrier methods (one by each partner)
• The male must use a condom (latex or other synthetic material)
• The female may select one of the following barrier methods: diaphragm, cervical, or contraceptive sponge
• Women who are lactating or breastfeeding.
• Women with a positive pregnancy test.
• Women planning to become pregnant during the study or within 5 months following treatment with investigational product.
• History or evidence of a clinically significant disorder (including psychiatric), condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
• History or evidence of any bacterial, viral, parasitic, or systemic fungal infections within the past 30 days prior to investigational product administration (eg, upper respiratory tract infection, viral syndrome, flu-like symptoms). Exception: a simple, short-duration common cold within the past 14 days prior to investigational product administration.
• A recent infection (within 6 months of randomization) requiring inpatient hospitalization or intravenous antibiotics.
• Known positive tuberculin skin test or exposure to an individual with tuberculosis (TB) or positive QuantiFERON® test or local equivalent (eg, T-Spot®) consistent with previous exposure to TB prior to or during screening (if not treated with appropriate chemoprophylaxis).

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

ABP 501; Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 16, 2023
• Study Start: November 24, 2014
• Primary Completion: December 4, 2015
• Study Completion: December 4, 2015
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.