Safety and EfficacyPhase 1MMB4(DMS)NCT02018250

Study to Evaluate the Safety of a New Oxime, MMB4 DIMETHANESULFONATE (DMS)

A Phase 1 study testing MMB4 DMS in people with Safety and Efficacy, run by U.S. Army Medical Research and Development Command at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This clinical study will evaluate escalating dosages of MMB4 DMS to determine its safety when delivered intramuscularly (i.m.) to the anterior thigh. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Safety and Efficacy
What is being tested?: MMB4 DMS
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 17 Mar 2012to Dec 2012
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

Subjects must be generally healthy adult male or female volunteers, 18-to-55 years-of age;
Subjects must be physically fit as determined by physical examination and BMI;
Subjects must have BMI of ≥ 19 and ≤ 30 kg/m2, and weight range of 55-85 kg;
Subjects must have adequate venous access;
Females of child bearing age must not be pregnant or breast-feeding, nor plan to become pregnant for the duration of the study, and all females must have a negative serum pregnancy test within 28 days of treatment, and a negative serum pregnancy test prior to dosing;
Females of childbearing potential must have been using adequate contraception, defined as the use of hormonal (oral, injectable, or implantable) or barrier-method contraceptives for at least one month prior to drug administration and must agree to use an adequate method of contraception for at least one month following drug administration. Women who are lactating will be excluded. Women without childbearing potential (who have undergone a total hysterectomy or bilateral oophorectomy, have a history of bilateral tubal ligation, or are two years post-menopausal) are also eligible;

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Males must agree to use a barrier form of birth control (i.e., condom with spermicidal gel) from the time of check-in to the clinical unit to 30 days after exposure to the study drug;
In the opinion of the Investigator, subjects who comply with the protocol and are likely to complete the study;
Subjects must provide written informed consent by signing and dating an IRB-approved written informed consent before any screening procedures are performed;
Subjects must be willing to refrain from donating blood for eight weeks after completion of the study period;
Subjects must be able to read/comprehend English; and
Subjects are non-smokers/tobacco/nicotine product users within three months of first dosing and must have a total lifetime exposure to cigarettes of <15 pack-years.

Who cannot join

Participation in a PK study or any other clinical study currently or within the last 30 days;
History or presence of significant cardiovascular, hepatic, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease that could potentially impact the safety of the subject or metabolism of the drug;
Have an active malignancy or history of metastatic or hematologic malignancy with the exception of melanoma in situ or basal or squamous cell carcinoma of the skin. Subjects must be disease-free for ten years;
History of glaucoma;
History of seizures;
History of allergic or untoward reaction to any bispyridinium oximes; or history allergy to cotton seed oil or history of anaphylactic shock;

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History of chronic pulmonary disease or current acute pulmonary disease; history of treatment for asthma or any other reactive airways disease in the past year;
Have ongoing drug abuse/dependence (including alcohol); or recent history (over the past five years) of treatment for alcohol or drug abuse; or a current positive urine tests for drug abuse;
Have consumed grapefruit, grapefruit juice, other grapefruit containing products, or starfruit within seven days prior to planned dosing;
Having taken, within 14 days of planned dosing, any prescription or non-prescription medication (including home remedies, herbal supplements or nutritional supplements) unless the Principal Investigator/Sub-Investigator, in consultation with the Sponsor Medical Monitor, provides a statement justifying that the medication taken will not impact the results of this study (with rare exceptions taking prescriptions drugs will be grounds for exclusion);
Preexistent renal insufficiency (estimated GFR using a GFR prediction equation <60 mL/min/1.73m^2, and/or other evidence of structural or functional abnormalities (e.g. PI assessment of the presence of clinically significant hematuria, proteinuria, or history of abnormalities on renal imaging) and/or abnormal BUN and serum creatinine or an abnormal urinalysis;
Skeletal muscle disease or evidence of skeletal muscle injury based on abnormal (>1.5 x ULN) blood creatine kinase and myoglobin levels;
Clinically relevant abnormal physical findings (including vital signs, pulse oximetry, and transcutaneous or end-tidal PCO2) or laboratory values at the pre-study period screening assessment that could interfere with the objectives of the study or the safety of the subject;
Clinically relevant ECG abnormalities based on three 12-lead ECGs obtained five minutes apart;
ECG with a PR interval ≥ 200 msec at screening or before dosing;
ECG with a QTc interval > 450 msec for males, 470 msec for females (QT interval corrected with Bazett formula);
Supine blood pressure less than 100/55 mmHg at screening or before dosing;
Ejection fraction less than 55% on screening echocardiogram;
Have spirometry with abnormal FEV1, FVC or FEV1/FVC ratio according to current American Thoracic Society/European Respiratory Society standards.
Have any specified laboratory values (e.g., hematology - complete blood count with differential, serum chemistry and urinalysis) outside the normal range for age and sex and deemed clinically significant by the Principal Investigator, within 28 days before treatment;
Have positive tests for hepatitis B surface antigen, hepatitis C, syphilis, human immunodeficiency virus (HIV) HIV-1 or HIV-2;
Have any skin condition that would interfere with injection of study drug; or
Donated >480 mL of blood in the last 8 weeks.

Trial locations and contacts

1 site in 1 country.

United States1 site

SNBL Clinical Pharmacology Center, Inc.
Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: A Phase 1 Double-Blind, Placebo-Controlled, Single-Center Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intramuscular Administration of a New Oxime, MMB4 DMS Enhanced Formulation (EF)

This clinical study will evaluate escalating dosages of MMB4 DMS to determine its safety when delivered intramuscularly (i.m.) to the anterior thigh.

Read the detailed description

The goal of this study is to assess safety, tolerability, and PK of MMB4 DMS EF at up to six cohorts chosen to provide the range required for PK analyses, including assessment of dose proportionality.

Conditions: Safety and Efficacy
Being tested: MMB4 DMS, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MMB4 DMSDrug
Also called 1,1'-methylenebis[4-[(hydroxyimino)methyl]-pyridinium] dimethanesulfonate
Subjects will be administered the drug product formulation at the assigned dosage of MMB4 DMS or placebo i.m. to the anterior thigh using a 5 mL syringe.
PlaceboDrug
Also called Benzyl alcohol USP/NF and methanesulfonic acid adjusted to a pH 2.3
Subjects will be administered the drug product formulation at the assigned dosage of placebo i.m. to the anterior thigh using a 5 mL syringe. The placebo group in each cohort will receive the same injection volume and number of injections as the dose group in that cohort.

Study groups in NCT02018250
Study group	Role	What they receive
0.6 mg/kg MMB4 DMS	Experimental	0.6 mg/kg 1,1'-Methylenebis[4-[(hydroxyimino) methyl]-pyridinium] dimethanesulfonate (MMB4 DMS), intramuscular (i.m.) to the anterior thigh. Receives: Drug: MMB4 DMS
Placebo	Placebo comparator	filtered cottonseed oil for injection. Three and a half milliliter aliquots of the placebo are placed in each 5-mL vial and administered intramuscular (i.m.) to the anterior thigh. Receives: Drug: Placebo
0.9 mg/kg MMB4 DMS	Experimental	0.9 mg/kg 1,1'-Methylenebis[4-[(hydroxyimino) methyl]-pyridinium] dimethanesulfonate (MMB4 DMS), intramuscular (i.m.) to the anterior thigh. Receives: Drug: MMB4 DMS
1.2 mg/kg MMB4 DMS	Experimental	1.2 mg/kg 1,1'-Methylenebis[4-[(hydroxyimino) methyl]-pyridinium] dimethanesulfonate (MMB4 DMS), intramuscular (i.m.) to the anterior thigh. Receives: Drug: MMB4 DMS
1.5 mg/kg MMB4 DMS	Experimental	1.5 mg/kg 1,1'-Methylenebis[4-[(hydroxyimino) methyl]-pyridinium] dimethanesulfonate (MMB4 DMS), intramuscular (i.m.) to the anterior thigh. Receives: Drug: MMB4 DMS

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Adverse Events (AE)
Measured: 30 days post-administration

Secondary outcomes (4)

Safety electrocardiogram (ECG) (3-5 lead)
Measured: Up to 48-hours post administration
Oxygen saturation
Measured: Up to 48-hours post administration
End-Tidal carbon dioxide
Measured: Up to 48 hours post administration
Blood pressure
Measured: Up to 48 hours post administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Mar 2012Dec 2012

First posted23 Dec 2013 (estimated)
Study start17 Mar 2012
Primary completion16 Oct 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Safety and EfficacyStudies 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02018250
Sponsor's protocol ID: MMB4-09-1001 S-12-08
Other IDs: S-12-08/A-15399.2
Acronym: MMB4(DMS)
Status last verified: May 2024
First submitted: 27 Dec 2012
Last updated: 23 May 2024
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Double-Blind, Placebo-Controlled, Single-Center Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intramuscular Administration of a New Oxime, MMB4 DMS Enhanced Formulation (EF)
ClinicalTrials.gov ID: NCT02018250
Acronym / sponsor ID: MMB4(DMS) / MMB4-09-1001 S-12-08
Conditions: Safety and Efficacy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: U.S. Army Medical Research and Development CommandUS federal agency
Study start: 17 Mar 2012 (actual)
Primary completion: 16 Oct 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 23 Dec 2013 (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.

This clinical study will evaluate escalating dosages of MMB4 DMS to determine its safety when delivered intramuscularly (i.m.) to the anterior thigh.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5

Arm	Type	Receives
0.6 mg/kg MMB4 DMS	Experimental	Drug: MMB4 DMS0.6 mg/kg 1,1'-Methylenebis[4-[(hydroxyimino) methyl]-pyridinium] dimethanesulfonate (MMB4 DMS), intramuscular (i.m.) to the anterior thigh.
Placebo	Placebo comparator	Drug: Placebofiltered cottonseed oil for injection. Three and a half milliliter aliquots of the placebo are placed in each 5-mL vial and administered intramuscular (i.m.) to the anterior thigh.
0.9 mg/kg MMB4 DMS	Experimental	Drug: MMB4 DMS0.9 mg/kg 1,1'-Methylenebis[4-[(hydroxyimino) methyl]-pyridinium] dimethanesulfonate (MMB4 DMS), intramuscular (i.m.) to the anterior thigh.
1.2 mg/kg MMB4 DMS	Experimental	Drug: MMB4 DMS1.2 mg/kg 1,1'-Methylenebis[4-[(hydroxyimino) methyl]-pyridinium] dimethanesulfonate (MMB4 DMS), intramuscular (i.m.) to the anterior thigh.
1.5 mg/kg MMB4 DMS	Experimental	Drug: MMB4 DMS1.5 mg/kg 1,1'-Methylenebis[4-[(hydroxyimino) methyl]-pyridinium] dimethanesulfonate (MMB4 DMS), intramuscular (i.m.) to the anterior thigh.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Subjects must be generally healthy adult male or female volunteers, 18-to-55 years-of age;
Subjects must be physically fit as determined by physical examination and BMI;
Subjects must have BMI of ≥ 19 and ≤ 30 kg/m2, and weight range of 55-85 kg;
Subjects must have adequate venous access;
Females of child bearing age must not be pregnant or breast-feeding, nor plan to become pregnant for the duration of the study, and all females must have a negative serum pregnancy test within 28 days of treatment, and a negative serum pregnancy test prior to dosing;

Key exclusion criteria (23 listed)

Participation in a PK study or any other clinical study currently or within the last 30 days;
History or presence of significant cardiovascular, hepatic, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease that could potentially impact the safety of the subject or metabolism of the drug;
Have an active malignancy or history of metastatic or hematologic malignancy with the exception of melanoma in situ or basal or squamous cell carcinoma of the skin. Subjects must be disease-free for ten years;
History of glaucoma;
History of seizures;

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
MMB4 DMSAlso: 1,1'-methylenebis[4-[(hydroxyimino)methyl]-pyridinium] dimethanesulfonateSubjects will be administered the drug product formulation at the assigned dosage of MMB4 DMS or placebo i.m. to the anterior thigh using a 5 mL syringe.	Drug	0.6 mg/kg MMB4 DMS, 0.9 mg/kg MMB4 DMS, 1.2 mg/kg MMB4 DMS, 1.5 mg/kg MMB4 DMS
PlaceboAlso: Benzyl alcohol USP/NF and methanesulfonic acid adjusted to a pH 2.3Subjects will be administered the drug product formulation at the assigned dosage of placebo i.m. to the anterior thigh using a 5 mL syringe. The placebo group in each cohort will receive the same injection volume and number of injections as the dose group in that cohort.	Drug	Placebo

Primary outcome

Number of Adverse Events (AE)
Time frame: 30 days post-administration

4 secondary outcomes

Safety electrocardiogram (ECG) (3-5 lead)
Time frame: Up to 48-hours post administration
Oxygen saturation
Time frame: Up to 48-hours post administration
End-Tidal carbon dioxide
Time frame: Up to 48 hours post administration
Blood pressure
Time frame: Up to 48 hours post administration

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 23 May 2024.

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Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
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Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
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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.

Mohamed S Al-Ibrahim, MD principal investigator

SNBL Clinical Pharmacology Center, Inc.

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 MMB4 DMS in people with Safety and Efficacy, run by U.S. Army Medical Research and Development Command at 1 site in United States.

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 12 inclusion and 23 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 23 May 2024. 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 United States. 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?

Number of Adverse Events (AE) (time frame: 30 days post-administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02018250.

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 23 May 2024.