A Study to Evaluate the Safety and Pharmacokinetics of NTM-1633 vs Placebo Administered Intravenously in Healthy Adults
Condition: Botulism
MeSH terms: Botulism
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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. Secondary
      Objectives: 1) To assess the pharmacokinetic characteristics of NTM-1633 following a single
      intravenous administration; 2) To assess the immunogenicity of NTM-1633 following a single
      intravenous administration.
    

Intervention name(s): NTM-1633; Placebo
Intervention type(s): Biological; Other
Intervention description(s): NTM-1633 is an equimolar mixture of three IgG1 monoclonal antibodies (mAb), referred to as XE02, XE06, and XE17 which bind to non-overlapping epitopes on Botulinum Neurotoxin (BoNT/E). Administered as a single intravenous infusion of NTM-1633 over one hour.; 0.9% Sodium Chloride Injection administered as a single intravenous infusion over one hour.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Botulism; Dose Escalation; Double-Blind; NTM-1633; Pharmacokinetics; Phase I; Safety