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Trial record 4 of 6 for:    M281

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02828046
Recruitment Status : Completed
First Posted : July 11, 2016
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Momenta Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Biological: M281 Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled, Single (Part 1) and Multiple (Part 2) Ascending Dose Study to Evaluate the Safety, Tolerability, PK and PD of M281 Administered to Healthy Volunteers
Actual Study Start Date : May 9, 2016
Actual Primary Completion Date : August 8, 2017
Actual Study Completion Date : August 8, 2017

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Other: Placebo
Experimental: M281
M281
Biological: M281



Primary Outcome Measures :
  1. Counts and Percentages of adverse events by treatment group [ Time Frame: Baseline until up-to 12 weeks post-dose ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02828046


Locations
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Netherlands
PRA Health Sciences
Zuidlaren, Netherlands
Sponsors and Collaborators
Momenta Pharmaceuticals, Inc.
Investigators
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Study Director: John Hogan, MPM Momenta Director of Clinical Operations
Principal Investigator: Tjerk Bosji, MD PRA Research Physician
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Responsible Party: Momenta Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02828046    
Other Study ID Numbers: MOM-M281-001
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided