A Study Comparing the Pharmacokinetics (PK) of ABP 501 40 mg/0.4 mL (ABP 501-HCF) and ABP 501 40 mg/0.8 ml (ABP 501-LCF) in Healthy Adult Participants

Study Overview
=================
Brief Summary
-----------------
To determine the pharmacokinetic (PK) comparability of ABP 501 40 mg/0.4 mL (ABP 501-HCF) compared to ABP 501 40 mg/0.8 mL (ABP 501-LCF) following single-dose subcutaneous (SC) injection, as assessed principally by area under the serum concentration-time curve (AUC) from time 0 extrapolated to infinity (AUCinf) and maximum observed serum concentration (Cmax) in healthy adult participants.

Official Title
-----------------
A Randomized, Single-blind, Single-dose, 2-arm, Parallel-group Study to Determine the Pharmacokinetic Comparability of ABP 501 40 mg/0.4 mL (ABP 501-HCF) and ABP 501 40 mg/0.8 mL (ABP 501-LCF) in Healthy Adult Subjects

Conditions
-----------------
Adalimumab

Intervention / Treatment
-----------------
* Drug: ABP 501-HCF
* Drug: ABP 501-LCF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must sign an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved informed consent form (ICF) before any study-specific procedures are performed. Healthy adult male or female participants between 18 and 55 years of age, inclusive, at the time of screening. Body weight of ≥ 50 kg and ≤ 90 kg. Body mass index (BMI) between 18.0 and 30.0 kg/m^2, inclusive. (BMI = weight [kg]/height[m^2]). Normal or clinically acceptable physical examination, clinical laboratory test values, vital signs, and 12-lead electrocardiogram as determined by the investigator, at screening and/or on Day -1. This determination must be recorded in the participant's source documents and initialed by the investigator. Chest X-ray with no evidence of current, active tuberculosis (TB) or previous (inactive) TB, other active infections, malignancy, or other clinically significant abnormalities, taken at screening or within 3 months prior to day 1 and read by a qualified radiologist. Chest X-ray may be substituted by a high resolution chest computed tomography (CT) or chest magnetic resonance imaging (MRI), if available within 3 months prior to screening. Participants must be able to communicate effectively with the study personnel. Exclusion Criteria: Female participant who is pregnant or breastfeeding or planning to become pregnant while participating in the study and for at least 5 months after the last dose of study drug. Female of childbearing potential who is sexually active with male partner and is unwilling to use an effective method of birth control. Effective birth control is defined as agreement to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 5 months after the last dose of study drug. Females of childbearing potential must also agree not to donate eggs (ova, oocytes for the purpose of assisted reproduction) for at least 5 months after the last dose of study drug. Female participant of childbearing potential with a positive serum pregnancy test at screening or a positive urine pregnancy test on Day -1. History or evidence of a clinically significant 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. Includes history of demyelinating disease or neurologic symptoms suggestive of demyelinating disease. History or presence of conditions or comorbidity known to interfere with the distribution, metabolism, or excretion of drugs or which may interfere with study assessment, including assessment of injection site, in the opinion of the investigator. Evidence of any bacterial, viral, parasitic, or systemic fungal infection within the past 30 days prior to randomization (e.g., upper respiratory tract infection, viral syndrome, flu-like symptoms). History or clinically significant chronic and/or recurrent infections, including but not limited to herpes zoster infection within 3 months prior to screening, renal or urinary tract infections (e.g., chronic pyelonephritis, recurrent cystitis), fungal infection (mucocutaneous candidiasis), or chronic pulmonary infection (e.g., bronchiectasis). Evidence of recent (within 3 months prior to randomization) infection requiring in-patient hospitalization or intravenous (IV) systemic anti-infectives. Participant has active TB, latent TB (defined as a positive result QuantiFERON® TB Gold test [or interferon gamma releasing assay {IGRA}] without any signs or symptoms of TB), a history of TB, or had close contact with a person with active TB within 12 weeks prior to administration of the study drug (Day 1); or participant has a repeat indeterminate QuantiFERON® TB Gold test (or IGRA equivalent). History of invasive systemic fungal infections (e.g., coccidiomycosis, histoplasmosis etc.) prior to or during the screening period. History of non-tuberculous mycobacterial or opportunistic infection 3 months prior to screening. History of surgery or major trauma within 3 months of screening, or surgery (requiring general anesthesia) planned during the study. History of malignancy of any type other than completely cured non-metastatic squamous or basal cell carcinoma of the skin, or in situ carcinoma of the uterine cervix within 5 years prior to screening. Positive screen for hepatitis B virus surface antigen, hepatitis B core antibody, or hepatitis C virus antibody. History of human immunodeficiency virus (HIV) or positive HIV serology at screening. Positive screen for alcohol and/or potential drugs of abuse (urine drug screen) at screening or prior to randomization or history of alcohol and/or substance abuse within the last 12 months prior to screening. Receiving or has received any investigational drug including investigational vaccine (or is currently using an investigational device) within the 30 days or 5 half-lives (whichever is longer) prior to randomization. Use of any over-the-counter or prescription medicines within the 14 days or 5 half-lives (whichever is longer) prior to randomization. Donated blood (including blood products) or experienced loss of blood ≥ 500 mL within 2 months prior to study drug administration. Received live viral or live bacterial vaccines within 3 months prior to randomization or is scheduled to receive a live vaccine within 3 months following treatment with study drug. Known or suspected intolerance, allergic reactions, or hypersensitivity to products derived from mammalian cells lines or any biologic medication. Known allergy to natural rubber (a derivative of latex). Previously received adalimumab or a biosimilar of adalimumab (investigational or marketed). Inability or unwillingness to reside at the clinical pharmacology unit for 2 consecutive days or inability to be available for follow-up assessments or protocol-required procedures. Participants who smoked >10 cigarettes per day within the last 3 months or not able to abide by the smoking policy of the site.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A: ABP 501-HCF<br>Participants will be administered a single SC dose of ABP 501-HCF on Day 1. | Drug: ABP 501-HCF<br>* Participants will receive a single-dose SC injection of ABP 501-HCF.<br>|
| Experimental: Treatment B: ABP 501-LCF<br>Participants will be administered a single SC dose of ABP 501-LCF on Day 1. | Drug: ABP 501-LCF<br>* Participants will receive a single-dose SC injection of ABP 501-LCF<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of ABP 501-HCF and ABP 501-LCF |  | Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63 | 
| Cmax of ABP 501-HCF and ABP 501-LCF |  | Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC from Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of ABP 501-HCF and ABP 501-LCF |  | Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63 | 
| Time at which Cmax is Observed (Tmax) of ABP 501-HCF and ABP 501-LCF |  | Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63 | 
| Terminal Elimination Half-life (t1/2) of ABP 501-HCF and ABP 501-LCF |  | Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63 | 
| Apparent Clearance (CL/F) of ABP 501-HCF and ABP 501-LCF |  | Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63 | 
| Apparent Volume of Distribution (Vz/F) of ABP 501-HCF and ABP 501-LCF |  | Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63 | 
| Mean Residence Time (MRT) of ABP 501-HCF and ABP 501-LCF |  | Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63 | 
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is an untoward medical occurrence in a clinical study irrespective of a causal relationship with the study treatment. The number of participants with TEAEs including serious AEs, clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests. | Day 1 until Day 63 | 
| Number of Participants with an Event of Interest |  | Day 1 until Day 63 | 
| Number of Participants with Binding and Neutralizing Anti-drug Antibodies |  | Pre-dose Day 1, Day 16, Day 29, and Day 63 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, Tumor necrosis factor, monoclonal antibody