NCT02779140

Phase I, Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of NTM-1632

A Phase I, Double-Blind, Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of NTM-1632 vs Placebo Administered Intravenously in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I, randomized, double-blind, placebo controlled dose escalation trial to evaluate NTM-1632 in three dose cohorts (A: 0.033 mg/kg, B: 0.165 mg/kg, and C: 0.33 mg/kg). NTM-1632 is a mixture of three monoclonal antibodies designed to treat botulinum neurotoxin BoNT/B poisoning in adults. Dose cohorts A, B, and C will be randomized 2:6, placebo:therapeutic, with a total study population of 24. The study duration is projected to be approximately 8 months, with subject participation in cohort A being approximately 13 weeks, and subject participation in cohort B and C being approximately 17 weeks. The primary objectives of this study are to assess the safety and tolerability of escalating doses of NTM-1632 administered intravenously in healthy adults.

Detailed description

This is a Phase I, randomized, double-blind, placebo controlled dose escalation trial to evaluate NTM-1632 in three dose cohorts (A: 0.033 mg/kg, B: 0.165 mg/kg, and C: 0.33 mg/kg). NTM-1632 is a mixture of three monoclonal antibodies designed to treat botulinum neurotoxin BoNT/B poisoning in adults. Dose cohorts A, B, and C will be randomized 2:6, placebo:therapeutic, with a total study population of 24. The study duration is projected to be approximately 8 months, with subject participation in cohort A being approximately 13 weeks, and subject participation in cohort B and C being approximately 17weeks. The primary objectives of this study are to assess the safety and tolerability of escalating doses of NTM-1632 administered intravenously in healthy adults. The secondary objectives are to 1) assess the pharmacokinetic characteristics of NTM-1632 following a single intravenous administration and 2) assess the immunogenicity of NTM-1632 following a single intravenous administration.

Conditions

• Botulism

Interventions

Type	Name	Description
BIOLOGICAL	NTM-1632	Monoclonal antibody mixture of XB10, XB18, and XB23
OTHER	Placebo	Placebo

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-05-31
• Completion: 2017-05-31
• First posted: 2016-05-20
• Last updated: 2018-10-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study