This is a Phase I, single-center, double-blind, placebo-controlled dose escalation trial of three dose cohorts (A: 0.033 mg/kg, B: 0.165 mg/kg, and C: 0.33 mg/kg). The purpose of this study is to evaluate the safety and tolerability of NTM-1633 in healthy adults. This is a first-in-human study consisting of three cohorts of eight subjects each. Dosing for each cohort is as follows: Two sentinel subjects will be administered a single 1-hour infusion (one NTM-1633, one placebo). No more than two subjects per day thereafter (at least 24 hrs will elapse between the dosing of each two subjects) will be dosed in the same manner until all subjects are dosed. Dose escalation will not occur until safety data through Day 8 is reviewed by the Safety Review Committee (SRC). Objective dose-escalation criteria and safety evaluations will be utilized. The study duration will be for approximately 8 months. Subjects in Cohort A will participate for approximately 17 weeks and Subjects in Cohorts B and C will participate approximately 21 weeks. Primary Objective: To assess the safety and tolerability of escalating doses of NTM-1633 administered intravenously in healthy adults.
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The occurrence of AEs
Timeframe: From Day 1 through Day 57
The occurrence of changes in absolute neutrophil count
Timeframe: From Day -1 through Day 91
The occurrence of changes in alanine transaminase (ALT) level
Timeframe: From Day -1 through Day 91
The occurrence of changes in aldolase level
Timeframe: From Day -1 through Day 91
The occurrence of changes in alkaline phosphatase level
Timeframe: From Day -1 through Day 91
The occurrence of changes in aspartate transaminase (AST) level
Timeframe: From Day -1 through Day 91
The occurrence of changes in blood urea nitrogen (BUN) level
Timeframe: From Day -1 through Day 91
The occurrence of changes in calcium level
Timeframe: From Day -1 through Day 91
The occurrence of changes in Complete Blood Count (CBC) with differential
Timeframe: From Day -1 through Day 91
The occurrence of changes in diastolic blood pressure in arm A
Timeframe: From Day -1 through Day 91
The occurrence of changes in diastolic blood pressure in arms B and C
Timeframe: From Day -1 through Day 121
The occurrence of changes in direct bilirubin level
Timeframe: From Day -1 through Day 91
The occurrence of changes in heart rate in arm A
Timeframe: From Day -1 through Day 91
The occurrence of changes in heart rate in arms B and C
Timeframe: From Day -1 through Day 121
The occurrence of changes in hemoglobin level
Timeframe: From Day -1 through Day 91
The occurrence of changes in indirect bilirubin level
Timeframe: From Day -1 through Day 91
The occurrence of changes in oral temperature in arm A
Timeframe: From Day -1 through Day 91
The occurrence of changes in oral temperature in arms B and C
Timeframe: From Day -1 through Day 121
The occurrence of changes in physical examination in arm A
Timeframe: From Day -1 through Day 91
The occurrence of changes in physical examination in arms B and C
Timeframe: From Day -1 through Day 121
The occurrence of changes in platelet count
Timeframe: From Day -1 through Day 91
The occurrence of changes in potassium level
Timeframe: From Day -1 through Day 91
The occurrence of changes in prothrombin time/international normalized ratio (INR)
Timeframe: From Day -1 through Day 91
The occurrence of changes in serum creatinine level
Timeframe: From Day -1 through Day 91
The occurrence of changes in sodium level
Timeframe: From Day -1 through Day 91
The occurrence of changes in systolic blood pressure in arm A
Timeframe: From Day -1 through Day 91
The occurrence of changes in systolic blood pressure in arms B and C
Timeframe: From Day -1 through Day 121
The occurrence of changes in total bilirubin level
Timeframe: From Day -1 through Day 91
The occurrence of changes in total creatine kinase (CK) level
Timeframe: From Day -1 through Day 91
The occurrence of changes in White Blood Cell (WBC) count
Timeframe: From Day -1 through Day 91
The occurrence of clinically significant ECG abnormalities
Timeframe: From Day -28 through Day 1
The occurrence of QT interval abnormalities
Timeframe: From Day -28 through Day 1
The occurrence of SAEs in arm A
Timeframe: From Day 1 through Day 91
The occurrence of SAEs in arms B and C
Timeframe: From Day 1 through Day 121
The presence of protein, blood, or glucose in urine
Timeframe: From Day -1 through Day 91