Phase 1a Single Ascending Dose Study of MIB-725 in Healthy Adults
ConditionHealthy Adults
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-60
SponsorMetro International Biotech, LLC
About this trial
This is a single center, open label (i.e. participants and study staff will not be masked to the intervention) single ascending dose study to evaluate the safety, tolerability, pharmaokinetics and pharmacodynamics of MIB-725 in community dwelling, healthy adults. Up to 4 successive groups (cohorts) of 8 subjects each will be enrolled in this trial.
This study will determine the safety and tolerability of orally administered single ascending (increasing) doses (100, 200, 400, and 800 mg) of MIB-725 in healthy adults. The safety will be assessed by evaluating physical examination that includes an external eye examination, vital signs, adverse events, and changes in blood counts, EKG, urinalysis, coagulation measures, and blood chemistries, including but not limited to blood glucose, electrolytes, creatinine, liver function tests, uric acid, and creatine kinase.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Is a non-smoking healthy adult, 19 to 60 years of age, inclusive
Has a body mass index (BMI) between 19 and 37.5 kg/m2, inclusive
Is free from clinically significant medical problems as determined by the Investigator
Is able and willing to provide written informed consent.
Disqualifiers
Is a current cigarette smoker
AST or ALT > 1.5 times the upper limit of normal
Hematocrit < 37% or > 51%
Diagnosis of diabetes mellitus, as indicated by use of diabetes medication, hemoglobin A1C > 6.4% or fasting glucose ≥126 mg/dL
Trial design
Design model
Single group
Treatments tested in this trial
MIB-725
DrugMIB-725 is a modified precursor of the NAD+ biosynthetic pathway.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: Safety and pharmacokinetic single dose ascending dose studyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Treatment-emergent adverse events
Any treatment-emergent adverse events, including any ocular adverse events
Time frame
Baseline to 28 days2
Treatment-emergent serious adverse events
Treatment-emergent serious adverse events, including any severe or serious ocular adverse events
Time frame
Baseline to 28 daysSecondary outcomes
1
Change in blood pressure
Change in blood pressure from baseline to 28 days
Time frame
Baseline to 28 days2
Change in heart rate
Change in heart rate from baseline to 28 days
Time frame
Baseline to 28 days3
Presence of conjunctival injection
Presence of conjunctival injection during eye examination
Time frame
Baseline to 28 days4
Change in QTc interval
Change in QTc interval measured using a12-lead electrocardiogram
Time frame
Baseline to 28 daysOther outcomes
1
changes in insulin sensitivity
changes in insulin sensitivity measured by the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame
Baseline to 28 days2
Change in total cholesterol
Change in total cholesterol
Time frame
Baseline to 28 days3
Changes from baseline in triglyceride
Change in fasting serum lipid - triglyceride
Time frame
Baseline to 28 days4
Change in HDL cholesterol
Change in fasting serum lipid: high-density lipoprotein (HDL) cholesterol
Time frame
Baseline to 28 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Metro International Biotech, LLC
Lead sponsor
Brigham and Women's Hospital
Sponsor institution
Source ClinicalTrials.gov