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CompletedNCT02828046Updated Oct 14, 2019

An Ascending Dose Study to Evaluate M281 Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD)

A Phase 1 interventional study of M281 and Placebo in Healthy Volunteers, sponsored by Momenta Pharmaceuticals, Inc.. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-14.

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

Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate safety, tolerability, and PK/PD of M281 after single and multiple doses in healthy volunteers.

02

Conditions studied

  • Healthy Volunteers
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 or female subjects between 18 and 55 years, inclusive.
  2. Good health
  3. Body weight between 50 and 110 kg inclusive

Exclusion criteria

Exclusion Criteria:

  1. History of any drug allergy, hypersensitivity, or intolerance to any drug product that in the opinion of the Investigator would place the subject at particular risk and compromise the safety of the subject in the study.
  2. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, psychiatric disease, or any other condition, that in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
  3. History or current diagnosis of substance dependence (except nicotine and caffeine) or alcohol abuse over the past 2 years, according to the criteria of DSM-IV-TR.
  4. Smokes or has smoked more than 5 cigarettes per day in the last 90 days and is unable to stop smoking during in-patient observation period in clinic.
  5. Unwillingness to abstain from alcohol for at least 24 hours prior to dosing with study medication until the time of discharge from the study unit and at least 24 hours prior to each ambulatory visit.
  6. Plans to participate in another clinical trial while enrolled in this study and/or received an investigational drug and/or device within 60 days prior to admission.
  7. Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days prior to admission.
  8. History of splenectomy, asthma (with the exception of childhood asthma that has resolved), COPD, recurrent or current GI or respiratory infections.
  9. On fluid restriction.
  10. Systemic steroids within 3 months prior to the start of study drug administration, or any prescription medication(s) within 14 days of dose administration or any non-prescribed systemic or topical medication (including any herbal product) within 7 days prior to dose administration.
  11. Vaccination within 1 month before dosing, or plans to receive vaccination during the study.
  12. Any illness within 5 days, or clinically significant airway infections within 30 days, prior to first study drug dosing.
  13. Positive urine drug screen (UDS) at screening.
  14. Positivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C at screening.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo

    Other: Placebo

  • Experimental
    M281

    M281

    Biological: M281

Interventions

  • BiologicalM281
  • OtherPlacebo
06

What researchers measure

Primary outcomes

  1. Counts and Percentages of adverse events by treatment group

    Time frame: Baseline until up-to 12 weeks post-dose

Secondary outcomes

  1. Serum concentrations of M281 will be summarized using descriptive statistics (arithmetic means, SDs, coefficients of variation, sample size, minimum, maximum, and geometric means).

    Time frame: Baseline up-to 12 weeks post-dose

  2. PD of M281 will summarize changes in serum markers of inflammation.

    Time frame: Up until 12 weeks post dose

07

Study locations

1 site
  • PRA Health Sciences
    Zuidlaren, Netherlands
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02828046
Lead sponsor
Momenta Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Jul 11, 2016
Start date
May 9, 2016
Primary completion
Aug 8, 2017
Completion
Aug 8, 2017
Last update
Oct 14, 2019

Study contacts

John Hogan, MPM
study director · Momenta Director of Clinical Operations
Tjerk Bosji, MD
principal investigator · PRA Research Physician

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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