Healthy VolunteersPhase 1NCT02828046
An Ascending Dose Study to Evaluate M281 Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD)
A Phase 1 study testing M281 in people with Healthy Volunteers, run by Momenta Pharmaceuticals, Inc. at 1 site in Netherlands.
Trial summary
The purpose of this study is to evaluate safety, tolerability, and PK/PD of M281 after single and multiple doses in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- M281
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 May 2016to 8 Aug 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects between 18 and 55 years, inclusive.
- Good health
- Body weight between 50 and 110 kg inclusive
Who cannot join
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- History of splenectomy, asthma (with the exception of childhood asthma that has resolved), COPD, recurrent or current GI or respiratory infections.
- On fluid restriction.
- 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.
- Vaccination within 1 month before dosing, or plans to receive vaccination during the study.
- Any illness within 5 days, or clinically significant airway infections within 30 days, prior to first study drug dosing.
- Positive urine drug screen (UDS) at screening.
- Positivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C at screening.
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of this study is to evaluate safety, tolerability, and PK/PD of M281 after single and multiple doses in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- M281, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M281Biological
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
| M281 | Experimental | M281 Receives: Biological: M281 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Counts and Percentages of adverse events by treatment group
Measured: Baseline until up-to 12 weeks post-dose
Secondary outcomes (2)
Serum concentrations of M281 will be summarized using descriptive statistics (arithmetic means, SDs, coefficients of variation, sample size, minimum, maximum, and geometric means).
Measured: Baseline up-to 12 weeks post-dose
PD of M281 will summarize changes in serum markers of inflammation.
Measured: Up until 12 weeks post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start9 May 2016
- Primary completion8 Aug 2017
- Study completion8 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Momenta Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Hogan, MPM, Study director, Momenta Director of Clinical OperationsTjerk Bosji, MD, Principal investigator, PRA Research Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828046
- Sponsor's protocol ID
- MOM-M281-001
- Status last verified
- Nov 2017
- First submitted
- 14 Jun 2016
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02828046
- Acronym / sponsor ID
- MOM-M281-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Momenta Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 May 2016 (actual)
- Primary completion
- 8 Aug 2017 (actual)
- Study completion
- 8 Aug 2017 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate safety, tolerability, and PK/PD of M281 after single and multiple doses in healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
| M281 | Experimental | Biological: M281M281 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male or female subjects between 18 and 55 years, inclusive.
- Good health
- Body weight between 50 and 110 kg inclusive
Key exclusion criteria (14 listed)
- 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.
- 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.
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M281 | Biological | M281 |
| Placebo | Other | Placebo |
Primary outcome
Counts and Percentages of adverse events by treatment group
Time frame: Baseline until up-to 12 weeks post-dose
2 secondary outcomes
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
PD of M281 will summarize changes in serum markers of inflammation.
Time frame: Up until 12 weeks post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Hogan, MPM study director
Momenta Director of Clinical Operations
Tjerk Bosji, MD principal investigator
PRA Research Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing M281 in people with Healthy Volunteers, run by Momenta Pharmaceuticals, Inc. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Counts and Percentages of adverse events by treatment group (time frame: Baseline until up-to 12 weeks post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2019.