AdalimumabPhase 1NCT05909852
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
A Phase 1 study testing ABP 501-HCF and ABP 501-LCF in people with Adalimumab, run by Amgen at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Adalimumab
- What is being tested?
- ABP 501-HCF and ABP 501-LCF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Jul 2021to 24 Nov 2021
- 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
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
WCCT Global, Inc
Cypress, California, 90630
Pharmaceutical Research Associates, Inc
Salt Lake City, Utah, 84124
Qps-Mra, Llc
South Miami, Florida, 33143
About this study
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
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.
- Conditions
- Adalimumab
- Being tested
- ABP 501-HCF, ABP 501-LCF
- Keywords
- Pharmacokinetics, Tumor necrosis factor, monoclonal antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABP 501-HCFDrug
Participants will receive a single-dose SC injection of ABP 501-HCF.
ABP 501-LCFDrug
Participants will receive a single-dose SC injection of ABP 501-LCF
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: ABP 501-HCF | Experimental | Participants will be administered a single SC dose of ABP 501-HCF on Day 1. Receives: Drug: ABP 501-HCF |
| Treatment B: ABP 501-LCF | Experimental | Participants will be administered a single SC dose of ABP 501-LCF on Day 1. Receives: Drug: ABP 501-LCF |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCinf of ABP 501-HCF and ABP 501-LCF
Measured: 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
Measured: 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 outcomes (9)
AUC from Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of ABP 501-HCF and ABP 501-LCF
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Day 1 until Day 63
Number of Participants with an Event of Interest
Measured: Day 1 until Day 63
Number of Participants with Binding and Neutralizing Anti-drug Antibodies
Measured: Pre-dose Day 1, Day 16, Day 29, and Day 63
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start23 Jul 2021
- Primary completion24 Nov 2021
- Study completion24 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AdalimumabStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909852
- Sponsor's protocol ID
- 20200286
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Publications
Chow V, Zhou M, Mytych DT, Colbert A, Miller MJ, Wala I, Sabet A, Radziszewski W. Pharmacokinetic, Safety, and Immunogenicity Similarity of High- and Low-Concentration Formulations of Adalimumab Biosimilar ABP 501, Adalimumab-Atto. Pharmacol Res Perspect. 2026 Apr;14(2):e70236. doi: 10.1002/prp2.70236.
PubMed 41857488
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05909852
- Acronym / sponsor ID
- 20200286
- Conditions
- Adalimumab
- Keywords
- Pharmacokinetics, Tumor necrosis factor, monoclonal antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 18 Jun 2023 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A: ABP 501-HCF | Experimental | Drug: ABP 501-HCFParticipants will be administered a single SC dose of ABP 501-HCF on Day 1. |
| Treatment B: ABP 501-LCF | Experimental | Drug: ABP 501-LCFParticipants will be administered a single SC dose of ABP 501-LCF on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
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 |
|---|---|---|
| ABP 501-HCFParticipants will receive a single-dose SC injection of ABP 501-HCF. | Drug | Treatment A: ABP 501-HCF |
| ABP 501-LCFParticipants will receive a single-dose SC injection of ABP 501-LCF | Drug | Treatment B: ABP 501-LCF |
Primary outcome
AUCinf of ABP 501-HCF and ABP 501-LCF
Time frame: 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
Time frame: 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
9 secondary outcomes
AUC from Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of ABP 501-HCF and ABP 501-LCF
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Day 1 until Day 63
Number of Participants with an Event of Interest
Time frame: Day 1 until Day 63
Number of Participants with Binding and Neutralizing Anti-drug Antibodies
Time frame: Pre-dose Day 1, Day 16, Day 29, and Day 63
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 25 Jun 2026.
- Background: PubMed 41857488Chow V, Zhou M, Mytych DT, Colbert A, Miller MJ, Wala I, Sabet A, Radziszewski W. Pharmacokinetic, Safety, and Immunogenicity Similarity of High- and Low-Concentration Formulations of Adalimumab Biosimilar ABP 501, Adalimumab-Atto. Pharmacol Res Perspect. 2026 Apr;14(2):e70236. doi: 10.1002/prp2.70236.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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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.
MD study director
Amgen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABP 501-HCF and ABP 501-LCF in people with Adalimumab, run by Amgen at 3 sites in United States.
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 7 inclusion and 25 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 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
AUCinf of ABP 501-HCF and ABP 501-LCF (time frame: 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). 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?
On the ClinicalTrials.gov record for NCT05909852, which also lists 1 linked publication.
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 25 Jun 2026.