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CompletedNCT02675023Updated Oct 15, 2019

Assessment of Pharmacokinetics and Safety of M923 Administered Via Auto-injector or Prefilled Syringe, in Healthy Subjects

A Phase 1 interventional study of M923 in Healthy, sponsored by Momenta Pharmaceuticals, Inc.. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-15.

Sponsored by Momenta Pharmaceuticals, Inc. · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
603
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Momenta Pharmaceuticals, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy male and female participants aged 18 to 55 years, inclusive
  2. Healthy participants as determined by pre-study medical history, physical examination, vital signs and 12-lead electrocardiogram (ECG)
  3. 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)
  4. 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
  5. 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.

  6. 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.

  7. 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
  8. 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)
  9. Participants who have provided written authorization for use and disclosure of protected health information
  10. Participants who agree to abide by the study schedule and dietary restrictions and to return for the required assessments

Exclusion criteria

Exclusion Criteria:

  1. 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
  2. Active or latent tuberculosis or who have a history of TB.
  3. History of invasive and/or active systemic fungal infections or other severe opportunistic infections, including recurrent or clinically significant chronic local fungal infections
  4. 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
  5. Herpes zoster infection in the last year or more than 2 herpes zoster infections in his/her lifetime
  6. Frequent chronic or recurrent infections (defined as >3 a year requiring prescribed treatment)
  7. Previous use of adalimumab, HUMIRA®, or another recombinant human monoclonal antibody
  8. 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
  9. History of alcohol abuse in the year preceding the screening visit, or history of excess alcohol consumption.
  10. 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)
  11. Donation of blood or blood products (eg, plasma, platelets) within 30 days prior to IP administration
  12. 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
  13. History of or existing congestive heart failure
  14. History of or existing signs or symptoms of demyelinating disease such as optic neuritis and/or multiple sclerosis
  15. History of any cancer including lymphoma, leukemia, skin cancer or cervical carcinoma in situ
  16. Impaired liver function
  17. 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)
  18. Positive test for anti-citrullinated protein antibodies at screening
  19. 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
  20. 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)
  21. Volunteers who are vegans or have medical dietary restrictions
  22. Volunteers who cannot communicate reliably with the investigator
  23. Volunteer is a family member or employee of the investigator or study site staff or study team
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
603 participants (actual)

Study arms

  • Experimental
    Auto-injector (AI)

    M923 administered via AI

    Biological: M923

  • Experimental
    Prefilled syringe (PFS)

    M923 administered via PFS

    Biological: M923

Interventions

  • BiologicalM923

    Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)

    Also known as: Adalimumab

06

What researchers measure

Primary outcomes

  1. 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 \[AUC(0-inf)\]

    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

  2. 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 \[AUC(0-336)\]

    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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Pharmacokinetics: Time of maximum concentration in serum [tmax]

    Obtained directly from the observed concentration versus time data

    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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. Non-serious and serious adverse events (SAEs)

    Time frame: Throughout the study period of approximately 8 months

  12. Incidence of injection site reactions

    Time frame: Throughout the study period of approximately 8 months

  13. Clinically significant changes in Vital signs

    Time frame: Throughout the study period of approximately 8 months

  14. 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.

    Time frame: Throughout the study period of approximately 8 months

  15. Clinically significant changes in Twelve-lead electrocardiogram (ECG)

    Time frame: Throughout the study period of approximately 8 months

  16. Clinically significant changes in laboratory results

    Time frame: Throughout the study period of approximately 8 months

  17. Clinically significant changes in clinical chemistry

    Time frame: Throughout the study period of approximately 8 months

  18. Clinically significant changes in urinalysis

    Time frame: Throughout the study period of approximately 8 months

07

Study locations

2 sites
  • QOPK Phase 1 Clinic
    Overland Park, Kansas 66211, United States
  • QLON Phase 1 Clinic
    London, SE1 1YR, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02675023
Lead sponsor
Momenta Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Feb 5, 2016
Start date
Jan 2016
Primary completion
Jul 2016
Completion
Jul 2016
Last update
Oct 15, 2019

Study contacts

John Caminis, MD
study director · Shire
View the source record on ClinicalTrials.gov ↗

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