Healthy VolunteersPhase 1NCT05995691
Study to Determine the Pharmacokinetic (PK) Bioequivalence of ABP 501 and Adalimumab (Humira®) in Healthy Adult Japanese Participants
A Phase 1 study testing ABP 501 and Adalimumab in people with Healthy Volunteers, run by Amgen.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ABP 501 and Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- No sites listed yet
- Study dates
- 24 Nov 2014to 4 Dec 2015
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 30Show fewer
- 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).
- Tuberculosis or fungal infection seen on available chest x-ray taken within 6 months of screening or at screening.
- History of malignancy of any type, other than surgically excised nonmelanomatous skin cancers, within 5 years prior to randomization.
- Positive test for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at screening.
- Positive screen for alcohol and/or potential drugs of abuse at screening or prior to randomization.
- Receiving or has received any investigational drug (or is currently using an investigational device) within 30 days or 5 half-lives (whichever is longer), prior to receiving investigational product.
- Use of any over-the-counter (OTC) or prescription medications within the 14 days or 5 half-lives (whichever is longer), prior to receiving investigational product. Acetaminophen (up to 2 g per day and not more than 4 g per week) for analgesia will be allowed. Hormonal contraceptives are allowed.
- All herbal medicines (eg, St. John's wort) and supplements consumed by the participant within the 30 days prior to receiving investigational product, and continuing use if applicable, will be reviewed by the investigator and the ICON medical monitor. Written documentation of this review and Amgen acknowledgment of the decision made with respect to eligibility is required for participant participation.
- Donated blood (including blood products) or experienced loss of blood ≥ 500 mL within 2 months of screening.
- Received live vaccines ≤ 3 months prior to investigational product administration or are scheduled to receive a live vaccine within 3 months following treatment with investigational product.
- Known or suspected sensitivity to products derived from mammalian cell lines.
- Known allergy to natural rubber (latex).
- Previously received adalimumab or a biosimilar of adalimumab.
- History of alcohol and/or substance abuse within the last 12 months from screening.
- Participants who use > 10 cigarettes per day within the last 3 months or not able to abide by the smoking policy of the clinical pharmacology unit (CPU).
- Inability or unwillingness to reside at the CPU for 2 consecutive days or inability to be available for follow-up assessments or protocol-required procedures.
About this study
Official title: A Randomized, Single-blind, Single-dose, 2-Arm, Parallel-group Study to Determine the Pharmacokinetic Bioequivalence of ABP 501 and Adalimumab (Humira®) in Healthy Adult Japanese Subjects
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
- Being tested
- ABP 501, Adalimumab
- Keywords
- ABP 501, Adalimumab, Humira®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABP 501Drug
SC injection
AdalimumabDrug
Also called Humira®
SC injection
| Study group | Role | What they receive |
|---|---|---|
| ABP 501 | Experimental | Participants will receive a single dose of ABP 501 Receives: Drug: ABP 501 |
| Adalimumab | Active comparator | Participants will receive a single dose of adalimumab Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCinf of ABP 501
Measured: Day 1 to Day 63
Cmax of ABP 501
Measured: Day 1 to Day 63
AUCinf of Adalimumab
Measured: Day 1 to Day 63
Cmax of Adalimumab
Measured: Day 1 to Day 63
Secondary outcomes (8)
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Any clinically significant changes in vital signs or clinical laboratory test results after the dose of treatment will be recorded as TEAEs.
Measured: Day 1 to Day 63
Number of Participants With Anti-drug Antibodies (ADA)
Measured: Day 1 to Day 63
Terminal Phase Elimination Half-life (t1/2) of ABP 501
Measured: Day 1 to Day 63
t1/2 of Adalimumab
Measured: Day 1 to Day 63
Time at Which the Maximum Observed Serum Concentration is Observed (Tmax) of ABP 501
Measured: Day 1 to Day 63
Tmax of Adalimumab
Measured: Day 1 to Day 63
Area Under the Serum Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUClast) of ABP 501
Measured: Day 1 to Day 63
AUClast of Adalimumab
Measured: Day 1 to Day 63
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start24 Nov 2014
- Primary completion4 Dec 2015
- Study completion4 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 179 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
- NCT05995691
- Sponsor's protocol ID
- 20120176
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. 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 Bioequivalence of ABP 501 and Adalimumab (Humira®) in Healthy Adult Japanese Subjects
- ClinicalTrials.gov ID
- NCT05995691
- Acronym / sponsor ID
- 20120176
- Conditions
- Healthy Volunteers
- Keywords
- ABP 501, Adalimumab, Humira®
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2014 (actual)
- Primary completion
- 4 Dec 2015 (actual)
- Study completion
- 4 Dec 2015 (actual)
- First posted
- 16 Aug 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABP 501 | Experimental | Drug: ABP 501Participants will receive a single dose of ABP 501 |
| Adalimumab | Active comparator | Drug: AdalimumabParticipants will receive a single dose of adalimumab |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (30 listed)
- 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:
- 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.
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 501SC injection | Drug | ABP 501 |
| AdalimumabAlso: Humira®SC injection | Drug | Adalimumab |
Primary outcome
AUCinf of ABP 501
Time frame: Day 1 to Day 63
Cmax of ABP 501
Time frame: Day 1 to Day 63
AUCinf of Adalimumab
Time frame: Day 1 to Day 63
Cmax of Adalimumab
Time frame: Day 1 to Day 63
8 secondary outcomes
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 to Day 63
Number of Participants With Anti-drug Antibodies (ADA)
Time frame: Day 1 to Day 63
Terminal Phase Elimination Half-life (t1/2) of ABP 501
Time frame: Day 1 to Day 63
t1/2 of Adalimumab
Time frame: Day 1 to Day 63
Time at Which the Maximum Observed Serum Concentration is Observed (Tmax) of ABP 501
Time frame: Day 1 to Day 63
Tmax of Adalimumab
Time frame: Day 1 to Day 63
Area Under the Serum Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUClast) of ABP 501
Time frame: Day 1 to Day 63
AUClast of Adalimumab
Time frame: Day 1 to 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 16 Aug 2023.
- 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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Screening Protocol
Pain
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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABP 501 and Adalimumab in people with Healthy Volunteers, run by Amgen.
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 8 inclusion and 30 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 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 (time frame: Day 1 to Day 63). The study lists 4 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 16 Aug 2023.