Healthy VolunteersPhase 1NCT02923583
Assessment of Pharmacokinetics (PK) and Safety of M834 and Orencia ®, in Healthy Subjects
A Phase 1 study testing M834, US-Sourced Orencia® and EU-Sourced Orencia® in people with Healthy Volunteers, run by Momenta Pharmaceuticals, Inc. at 2 sites in United Kingdom.
Trial summary
The purpose of this study is assess the pharmacokinetics and safety of M834 and Orencia ® following administration of a single-dose in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- M834, US-Sourced Orencia® and EU-Sourced Orencia®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2016to 21 Jul 2017
- 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
- Male or females 18 to 55 years of age, inclusive (of any ethnic origin).
- Healthy as determined by medical history, physical examination, vital signs, and 12 lead electrocardiography (ECG) at screening.
- Body mass index (BMI) between 18 and 32 kg/m2.
- Body weight between 50.0 and 100.0 kg, inclusive.
- Has smoked no more than 10 cigarettes, 3 cigars, or 3 pipes/day for at least 1 month prior to screening and is willing to comply with smoking restrictions during confinement at the study center.
- Willing and able to comply with the requirements of the study.
- Willing and able to sign a written informed consent.
Who cannot join
- History and/or current presence of clinically significant angioedema, clinically significant hypersensitivity, or severe allergic reactions (either spontaneous or following drug administration), also including known or suspected clinically relevant drug hypersensitivity to any components of the study drugs or comparable drugs, or latex.
- History of invasive systemic fungal infections (e.g., histoplasmosis, coccidioidomycosis) or other severe opportunistic infections; subjects with well-controlled or mild recurrent or chronic local fungal infections (e.g., tinea versicolor, onychomycosis, athlete's foot) may be included at the discretion of the Investigator.
- A serious infection (associated with hospitalization and/or required intravenous anti-infectives) within 6 months of study drug administration or a significant infection requiring oral or topical anti-infectives within 4 weeks of study drug administration.
- Any minor infection within 2 weeks of admission to the clinical unit on Day -1 that, in the opinion of the Investigator, may require systemic therapy or otherwise impact safety or participation in the study.
- Herpes zoster infection in the last year or more than 1 herpes zoster infections in his/her lifetime.
- Frequent chronic or recurrent infections (defined as >3 a year requiring prescribed antibiotic treatment; subjects with >3 viral upper respiratory infections may be considered based on Investigator discretion).
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- Previous administration of abatacept, belatacept, or biosimilar candidates referencing abatacept or belatacept.
- Receipt of another recombinant human monoclonal antibody within 6 months prior to dosing in this trial, or within 5 half-lives, or within the expected period of pharmacodynamic effect; whichever is longest.
- Intake of any study drug in another trial within 3 months prior to dosing in this trial or have received the last dose of an investigational drug >3 months ago but who are on extended follow-up, or planned dosing of an investigational drug (other than for this study) during the course of this trial.
- History of alcohol abuse in the past year, or history of regular consumption of alcohol, or unwillingness to comply with the alcohol restrictions outlined.
- History of drug abuse.
- Donation of blood within 3 months or blood products (e.g., platelets within 6 weeks, plasma within 7 days) prior to dosing.
- Use of any prescribed or non-prescribed medication, dietary supplements or herbal medication during the 2 weeks prior to dosing.
- History of or current congestive heart failure.
- History of or current signs or symptoms of demyelinating disease including optic neuritis and/or multiple sclerosis.
- History of any cancer including lymphoma, leukemia, skin cancer and cervical carcinoma in situ.
- History of immunodeficiency (including those subjects with a positive test for human immunodeficiency virus [HIV] I and II at screening) or other clinically significant immunological disorders, or auto-immune disorders. Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, metabolic, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders as judged by the investigator.
- Received a live vaccine within 12 weeks prior to clinic admission (Day -1) or plan to receive a live vaccine during the study (up to and including Day 71).
- Pregnant or breast-feeding women.
- Men or women of childbearing potential who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include use of a condom with spermicide and one of the following highly effective methods: stable use of oral contraceptives or other prescription pharmaceutical contraceptive, intrauterine device (IUD); bilateral tubal ligation, vasectomy, additional barrier method [e.g., diaphragm, cap, sponge]).
- Contraception is not required for subjects who are abstinent (abstinence should be their preferred and usual lifestyle; contraception should be used as described if subjects stop being abstinent), subjects in exclusive same-sex relationships, and post-menopausal females.
- Postmenopausal women must be amenorrheic for at least 12 months, confirmed by follicle-stimulating hormone (FSH) level >40 IU/L at screening in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Covance Clincal Research Unit Ltd
Leeds, LS2 9LH
Hammersmith Medicines Research (HMR)
London, NW10 7EW
About this study
Official title: A Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, and Immunogenicity of M834 (Abatacept Biosimilar Candidate), US-Sourced Orencia®, and European Union (EU)-Sourced Orencia® in Normal Healthy Volunteers
The purpose of this study is assess the pharmacokinetics and safety of M834 and Orencia ® following administration of a single-dose in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- M834, US-Sourced Orencia®, EU-Sourced Orencia®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M834Biological
US-Sourced Orencia®Biological
Also called Abatacept
EU-Sourced Orencia®Biological
Also called Abatacept
| Study group | Role | What they receive |
|---|---|---|
| M834 | Experimental | M834 (abatacept biosimilar candidate) Receives: Biological: M834 |
| US Orencia® | Active comparator | US-sourced Orencia® (abatacept) Receives: Biological: US-Sourced Orencia® |
| EU Orencia® | Active comparator | EU-sourced Orencia® (abatacept) Receives: Biological: EU-Sourced Orencia® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum serum concentration (Cmax)
Measured: Pre-dose; and post dose through day 85.
Area under the serum concentration (AUC) versus time curve from zero to last quantifiable concentration [AUC(0-last)]
Measured: Pre-dose; and post dose through day 85.
Area under the concentration-time curve in serum from time zero extrapolated to infinity [AUC(0-inf)]
Measured: Pre-dose; and post dose through day 85.
Secondary outcomes (2)
The incidence of anti-drug antibodies (ADAs)
Measured: Pre-dose; and post dose through day 85.
Count and percentages of adverse events by treatment group.
Measured: Time of dosing up-to Day 85 post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion21 Jul 2017
- Study completion21 Jul 2017
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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Momenta Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mylan Inc.
- Responsible party
- Sponsor
- Investigators
- Candida Fratazzi, MD, Study director, Momenta Pharmaceuticals, Inc.James Bush, MBChB, PhD, MRCS(Ed), MFPM, Principal investigator, Covance Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923583
- Sponsor's protocol ID
- MOM-M834-001
- Status last verified
- Oct 2017
- First submitted
- 8 Aug 2016
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, and Immunogenicity of M834 (Abatacept Biosimilar Candidate), US-Sourced Orencia®, and European Union (EU)-Sourced Orencia® in Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02923583
- Acronym / sponsor ID
- MOM-M834-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Momenta Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Mylan Inc.
- Study start
- Oct 2016
- Primary completion
- 21 Jul 2017 (actual)
- Study completion
- 21 Jul 2017 (actual)
- First posted
- 4 Oct 2016 (estimated)
- 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 purpose of this study is assess the pharmacokinetics and safety of M834 and Orencia ® following administration of a single-dose in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| M834 | Experimental | Biological: M834M834 (abatacept biosimilar candidate) |
| US Orencia® | Active comparator | Biological: US-Sourced Orencia®US-sourced Orencia® (abatacept) |
| EU Orencia® | Active comparator | Biological: EU-Sourced Orencia®EU-sourced Orencia® (abatacept) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or females 18 to 55 years of age, inclusive (of any ethnic origin).
- Healthy as determined by medical history, physical examination, vital signs, and 12 lead electrocardiography (ECG) at screening.
- Body mass index (BMI) between 18 and 32 kg/m2.
- Body weight between 50.0 and 100.0 kg, inclusive.
- Has smoked no more than 10 cigarettes, 3 cigars, or 3 pipes/day for at least 1 month prior to screening and is willing to comply with smoking restrictions during confinement at the study center.
Key exclusion criteria (22 listed)
- History and/or current presence of clinically significant angioedema, clinically significant hypersensitivity, or severe allergic reactions (either spontaneous or following drug administration), also including known or suspected clinically relevant drug hypersensitivity to any components of the study drugs or comparable drugs, or latex.
- History of invasive systemic fungal infections (e.g., histoplasmosis, coccidioidomycosis) or other severe opportunistic infections; subjects with well-controlled or mild recurrent or chronic local fungal infections (e.g., tinea versicolor, onychomycosis, athlete's foot) may be included at the discretion of the Investigator.
- A serious infection (associated with hospitalization and/or required intravenous anti-infectives) within 6 months of study drug administration or a significant infection requiring oral or topical anti-infectives within 4 weeks of study drug administration.
- Any minor infection within 2 weeks of admission to the clinical unit on Day -1 that, in the opinion of the Investigator, may require systemic therapy or otherwise impact safety or participation in the study.
- Herpes zoster infection in the last year or more than 1 herpes zoster infections in his/her lifetime.
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 |
|---|---|---|
| M834 | Biological | M834 |
| US-Sourced Orencia®Also: Abatacept | Biological | US Orencia® |
| EU-Sourced Orencia®Also: Abatacept | Biological | EU Orencia® |
Primary outcome
Maximum serum concentration (Cmax)
Time frame: Pre-dose; and post dose through day 85.
Area under the serum concentration (AUC) versus time curve from zero to last quantifiable concentration [AUC(0-last)]
Time frame: Pre-dose; and post dose through day 85.
Area under the concentration-time curve in serum from time zero extrapolated to infinity [AUC(0-inf)]
Time frame: Pre-dose; and post dose through day 85.
2 secondary outcomes
The incidence of anti-drug antibodies (ADAs)
Time frame: Pre-dose; and post dose through day 85.
Count and percentages of adverse events by treatment group.
Time frame: Time of dosing up-to Day 85 post-dose.
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 24 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
Candida Fratazzi, MD study director
Momenta Pharmaceuticals, Inc.
James Bush, MBChB, PhD, MRCS(Ed), MFPM principal investigator
Covance Clinical Research Unit
2 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 M834, US-Sourced Orencia® and EU-Sourced Orencia® in people with Healthy Volunteers, run by Momenta Pharmaceuticals, Inc. at 2 sites in United Kingdom.
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 22 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 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Maximum serum concentration (Cmax) (time frame: Pre-dose; and post dose through day 85.). The study lists 3 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 24 Oct 2017.