An Ascending Dose Study to Evaluate M281 Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD)
Study Details
Study Description
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 |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Placebo |
Other: Placebo
|
| Experimental: M281 M281 |
Biological: M281
|
Outcome Measures
Primary Outcome Measures
- Counts and Percentages of adverse events by treatment group [Baseline until up-to 12 weeks post-dose]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy male or female subjects between 18 and 55 years, inclusive.
-
Good health
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Body weight between 50 and 110 kg inclusive
Exclusion Criteria:
-
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.
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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.
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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.
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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.
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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.
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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.
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Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days prior to admission.
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History of splenectomy, asthma (with the exception of childhood asthma that has resolved), COPD, recurrent or current GI or respiratory infections.
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On fluid restriction.
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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.
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Vaccination within 1 month before dosing, or plans to receive vaccination during the study.
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Any illness within 5 days, or clinically significant airway infections within 30 days, prior to first study drug dosing.
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Positive urine drug screen (UDS) at screening.
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Positivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C at screening.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | PRA Health Sciences | Zuidlaren | Netherlands |
Sponsors and Collaborators
- Momenta Pharmaceuticals, Inc.
Investigators
- Study Director: John Hogan, MPM, Momenta Director of Clinical Operations
- Principal Investigator: Tjerk Bosji, MD, PRA Research Physician
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MOM-M281-001