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Phase I, Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of NTM-1632
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.
Details
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | PHASE1 |
| Status | COMPLETED |
| Enrolment | 24 |
| Start date | Mon Aug 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Wed May 31 2017 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Botulism
Interventions
- NTM-1632
- Placebo
Countries
United States