Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02779140 · ClinicalTrials.gov registry record · Phase 1
Phase I, Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of NTM-1632
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02779140 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 24 participants.
The verdict
NCT02779140, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study 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.
Interventions
- OTHER Placebo
- BIOLOGICAL NTM-1632
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-08-01 |
| Est. Completion | 2017-05-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02779140
The ClinicalTrials.gov registry entry for NCT02779140 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02779140 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02779140 about?
NCT02779140 is a clinical study titled "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...
What is the current status of trial NCT02779140?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2016-08-01. Estimated completion is 2017-05-31.
What interventions are being tested in trial NCT02779140?
The interventions under investigation include: Placebo (OTHER), NTM-1632 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02779140?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.