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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Placebo; Biological: M281

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Zuidlaren, Netherlands
    • PRA Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Other: Placebo
EXPERIMENTAL: M281	Biological: M281

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Counts and Percentages of adverse events by treatment group	Baseline until up-to 12 weeks post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum concentrations of M281 will be summarized using descriptive statistics (arithmetic means, SDs, coefficients of variation, sample size, minimum, maximum, and geometric means).	Baseline up-to 12 weeks post-dose
PD of M281 will summarize changes in serum markers of inflammation.	Up until 12 weeks post dose

Collaborators and Investigators

• Sponsor: Momenta Pharmaceuticals, Inc.
• Investigators: Study Director: John Hogan, MPM, Momenta Director of Clinical Operations; Principal Investigator: Tjerk Bosji, MD, PRA Research Physician

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 9, 2016
• Primary Completion (ACTUAL): August 8, 2017
• Study Completion (ACTUAL): August 8, 2017

Study Registration Dates

• First Submitted: June 14, 2016
• First Submitted That Met QC Criteria: July 6, 2016
• First Posted (ESTIMATE): July 11, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2019
• Last Update Submitted That Met QC Criteria: October 11, 2019
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: MOM-M281-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED