HealthyPhase 1NCT02675023
Assessment of Pharmacokinetics and Safety of M923 Administered Via Auto-injector or Prefilled Syringe, in Healthy Subjects
A Phase 1 study testing M923 in people with Healthy, run by Momenta Pharmaceuticals, Inc. at 2 sites in 2 countries.
Trial summary
This study will assess the pharmacokinetic (PK) and safety of a single 0.8 mL (40 mg) subcutaneous (SC) dose of M923 administered via an auto-injector (AI) or a prefilled syringe (PFS) in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- M923
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 603 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2016to Jul 2016
- 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
- Healthy male and female participants aged 18 to 55 years, inclusive
- Healthy participants as determined by pre-study medical history, physical examination, vital signs and 12-lead electrocardiogram (ECG)
- Participants with clinical laboratory test results that are not clinically significant and are acceptable to the investigator at screening and admission to the study site (Day -1)
- Participants with a body weight between 60.0 kg and 100.0 kg and a body mass index between 18.5 kg/m2 and 34.9 kg/m2, inclusive
- Healthy male participants must be willing to comply with the contraception restrictions for this study.
- -Male participants with non-pregnant female partners of childbearing potential should avoid conception of a child during the study (up to Day 71 post-dose) and for 90 days thereafter.
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- Healthy female participants must have a negative pregnancy test at screening and on admission to the study site (Day -1), must not be lactating and must be using an acceptable method of contraception throughout the study and for 30 days after study completion, or be of non-childbearing potential.
- -Non-pregnant female partners of male participants who are of childbearing potential should use an effective form of contraception.
- Participants who have smoked ≤10 cigarettes or 3 cigars or 3 pipes/day for at least 3 months prior to screening and are willing to comply with smoking restrictions during residency at the study site
- Participants who are able to understand and provide written informed consent including signature on an informed consent form (ICF) approved by an Ethics Committee (EC)/ Institutional Review Board (IRB)
- Participants who have provided written authorization for use and disclosure of protected health information
- Participants who agree to abide by the study schedule and dietary restrictions and to return for the required assessments
Who cannot join
- History and/or current presence of clinically significant angioedema, or eczematous dermatitis that requires prescription medication, clinically significant hypersensitivity, or severe allergic reactions (either spontaneous or following IP administration), also including known or suspected clinically relevant drug hypersensitivity to any components of the IP or comparable drugs, including latex
- Active or latent tuberculosis or who have a history of TB.
- History of invasive and/or active systemic fungal infections or other severe opportunistic infections, including recurrent or clinically significant chronic local fungal infections
- A serious infection within 6 months prior to investigational product (IP) administration and/or an infection within 2 weeks of screening or during the screening period unless resolved completely within 2 weeks of admission to the study site on Day -1
- Herpes zoster infection in the last year or more than 2 herpes zoster infections in his/her lifetime
- Frequent chronic or recurrent infections (defined as >3 a year requiring prescribed treatment)
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- Previous use of adalimumab, HUMIRA®, or another recombinant human monoclonal antibody
- Intake of any investigational drug in another study within 30 days (or 5 half-lives, whichever is greater) prior to intake of IP in this study or have received the last dose of a study drug more than 30 days ago (or 5 half-lives, whichever is greater) but who are on extended follow-up, or planned intake of an investigational drug (other than for this study) during the course of this study
- History of alcohol abuse in the year preceding the screening visit, or history of excess alcohol consumption.
- Known history of opioid or cocaine drug abuse or any other drug abuse in the past year or positive tests for drugs of abuse or alcohol at screening or admission to the study site (Day -1)
- Donation of blood or blood products (eg, plasma, platelets) within 30 days prior to IP administration
- Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), dietary supplements or herbal medication during the 2 weeks prior to IP administration or longer if the medication has a long half-life. Use of any medication deemed necessary by the participant's physician to treat or prevent any medical condition, paracetamol/acetaminophen ≤3 g/day and use of vitamins at daily recommended doses is allowed; for female volunteers, oral birth control and hormone replacement therapy is allowed
- History of or existing congestive heart failure
- History of or existing signs or symptoms of demyelinating disease such as optic neuritis and/or multiple sclerosis
- History of any cancer including lymphoma, leukemia, skin cancer or cervical carcinoma in situ
- Impaired liver function
- History of immunodeficiency (including those participants with a positive test for human immunodeficiency virus [HIV] I and II at screening) or other clinically significant immunological disorders, or auto-immune disorders, (eg, rheumatoid arthritis, lupus erythematosus, scleroderma, psoriasis)
- Positive test for anti-citrullinated protein antibodies at screening
- Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological (including pancytopenia, aplastic anemia, or blood dyscrasia), metabolic (including known diabetes mellitus), 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 admission to the study site (Day -1) or plan to receive a live vaccine during the study (up to and including Day 71)
- Volunteers who are vegans or have medical dietary restrictions
- Volunteers who cannot communicate reliably with the investigator
- Volunteer is a family member or employee of the investigator or study site staff or study team
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomized, Open-label, Two-arm, Parallel Group, Single Dose Study to Assess the Pharmacokinetics and Safety of M923 Administered Via Auto-injector or Prefilled Syringe, in Healthy Subjects
This study will assess the pharmacokinetic (PK) and safety of a single 0.8 mL (40 mg) subcutaneous (SC) dose of M923 administered via an auto-injector (AI) or a prefilled syringe (PFS) in healthy subjects.
- Conditions
- Healthy
- Being tested
- M923
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M923Biological
Also called Adalimumab
Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)
| Study group | Role | What they receive |
|---|---|---|
| Auto-injector (AI) | Experimental | M923 administered via AI Receives: Biological: M923 |
| Prefilled syringe (PFS) | Experimental | M923 administered via PFS Receives: Biological: M923 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Area under the concentration-time curve from 0 to infinity
Area under the concentration-time curve in serum from time zero (predose) extrapolated to infinity [AUC(0-inf)]
Measured: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Area under the concentration-time curve from 0 to 336 hours
Area under the concentration-time curve in serum from time zero (predose) to 336 hours postdose [AUC(0-336)]
Measured: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, and 15
Pharmacokinetics: Maximum concentration in serum (Cmax)
Measured: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Secondary outcomes (18)
Pharmacokinetics: Serum M923 concentration up to Day 71
Measured: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Area under the concentration-time curve in serum from time zero (predose) to 1200 hours postdose [AUC(0-1200)]
Measured: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, and 50
Pharmacokinetics: Area under the concentration-time curve in serum from time zero (predose) to time of the last quantifiable concentration [AUC(0-last)]
Measured: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Time of maximum concentration in serum [tmax]
Obtained directly from the observed concentration versus time data
Measured: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Terminal rate constant (λ z)
Measured: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Terminal half-life (t½)
Measured: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Apparent volume of distribution (Vz/F)
Measured: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Apparent systemic clearance after extravascular dosing (CL/F)
Measured: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Area under the concentration-time curve extrapolated from time "t" to infinity [% AUCex]
Measured: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Area under the serum concentration-time curves from time zero (predose) to time "t" [AUC(0-t)] by which >20.0% of participants have developed neutralizing antidrug antibody [nADA]
Measured: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Non-serious and serious adverse events (SAEs)
Measured: Throughout the study period of approximately 8 months
Incidence of injection site reactions
Measured: Throughout the study period of approximately 8 months
Clinically significant changes in Vital signs
Measured: Throughout the study period of approximately 8 months
Number of participants with new clinically significant findings from the physical examination
Physical examination will be done on the following body systems: general appearance, head and neck, eyes and ears, nose and throat, chest, lungs, heart, abdomen, extremities and joints, lymph nodes, skin, and neurological.
Measured: Throughout the study period of approximately 8 months
Clinically significant changes in Twelve-lead electrocardiogram (ECG)
Measured: Throughout the study period of approximately 8 months
Clinically significant changes in laboratory results
Measured: Throughout the study period of approximately 8 months
Clinically significant changes in clinical chemistry
Measured: Throughout the study period of approximately 8 months
Clinically significant changes in urinalysis
Measured: Throughout the study period of approximately 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 603 participants (actual)
Sponsor and investigators
- Lead sponsor
- Momenta Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Caminis, MD, Study director, Shire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675023
- Sponsor's protocol ID
- 911501
- Status last verified
- Apr 2017
- First submitted
- 22 Jan 2016
- Last updated
- 15 Oct 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Two-arm, Parallel Group, Single Dose Study to Assess the Pharmacokinetics and Safety of M923 Administered Via Auto-injector or Prefilled Syringe, in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02675023
- Acronym / sponsor ID
- 911501
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 603 participants (actual)
- Lead sponsor
- Momenta Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 5 Feb 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.
This study will assess the pharmacokinetic (PK) and safety of a single 0.8 mL (40 mg) subcutaneous (SC) dose of M923 administered via an auto-injector (AI) or a prefilled syringe (PFS) in healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auto-injector (AI) | Experimental | Biological: M923M923 administered via AI |
| Prefilled syringe (PFS) | Experimental | Biological: M923M923 administered via PFS |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy male and female participants aged 18 to 55 years, inclusive
- Healthy participants as determined by pre-study medical history, physical examination, vital signs and 12-lead electrocardiogram (ECG)
- Participants with clinical laboratory test results that are not clinically significant and are acceptable to the investigator at screening and admission to the study site (Day -1)
- Participants with a body weight between 60.0 kg and 100.0 kg and a body mass index between 18.5 kg/m2 and 34.9 kg/m2, inclusive
- Healthy male participants must be willing to comply with the contraception restrictions for this study.
Key exclusion criteria (23 listed)
- History and/or current presence of clinically significant angioedema, or eczematous dermatitis that requires prescription medication, clinically significant hypersensitivity, or severe allergic reactions (either spontaneous or following IP administration), also including known or suspected clinically relevant drug hypersensitivity to any components of the IP or comparable drugs, including latex
- Active or latent tuberculosis or who have a history of TB.
- History of invasive and/or active systemic fungal infections or other severe opportunistic infections, including recurrent or clinically significant chronic local fungal infections
- A serious infection within 6 months prior to investigational product (IP) administration and/or an infection within 2 weeks of screening or during the screening period unless resolved completely within 2 weeks of admission to the study site on Day -1
- Herpes zoster infection in the last year or more than 2 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 |
|---|---|---|
| M923Also: AdalimumabRecombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α) | Biological | Auto-injector (AI), Prefilled syringe (PFS) |
Primary outcome
Pharmacokinetics: Area under the concentration-time curve from 0 to infinity
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Area under the concentration-time curve in serum from time zero (predose) extrapolated to infinity [AUC(0-inf)]
Pharmacokinetics: Area under the concentration-time curve from 0 to 336 hours
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, and 15
Area under the concentration-time curve in serum from time zero (predose) to 336 hours postdose [AUC(0-336)]
Pharmacokinetics: Maximum concentration in serum (Cmax)
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
18 secondary outcomes
Pharmacokinetics: Serum M923 concentration up to Day 71
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Area under the concentration-time curve in serum from time zero (predose) to 1200 hours postdose [AUC(0-1200)]
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, and 50
Pharmacokinetics: Area under the concentration-time curve in serum from time zero (predose) to time of the last quantifiable concentration [AUC(0-last)]
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Time of maximum concentration in serum [tmax]
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Terminal rate constant (λ z)
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Terminal half-life (t½)
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Apparent volume of distribution (Vz/F)
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Apparent systemic clearance after extravascular dosing (CL/F)
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Area under the concentration-time curve extrapolated from time "t" to infinity [% AUCex]
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Area under the serum concentration-time curves from time zero (predose) to time "t" [AUC(0-t)] by which >20.0% of participants have developed neutralizing antidrug antibody [nADA]
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Non-serious and serious adverse events (SAEs)
Time frame: Throughout the study period of approximately 8 months
Incidence of injection site reactions
Time frame: Throughout the study period of approximately 8 months
Clinically significant changes in Vital signs
Time frame: Throughout the study period of approximately 8 months
Number of participants with new clinically significant findings from the physical examination
Time frame: Throughout the study period of approximately 8 months
Clinically significant changes in Twelve-lead electrocardiogram (ECG)
Time frame: Throughout the study period of approximately 8 months
Clinically significant changes in laboratory results
Time frame: Throughout the study period of approximately 8 months
Clinically significant changes in clinical chemistry
Time frame: Throughout the study period of approximately 8 months
Clinically significant changes in urinalysis
Time frame: Throughout the study period of approximately 8 months
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 15 Oct 2019.
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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.
John Caminis, MD study director
Shire
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing M923 in people with Healthy, run by Momenta Pharmaceuticals, Inc. at 2 sites in 2 countries.
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 12 inclusion and 23 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 15 Oct 2019. 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 States, 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?
Pharmacokinetics: Area under the concentration-time curve from 0 to infinity (time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71). 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 15 Oct 2019.