Botulism Clinical Trial
Official title:
A Phase I, Double-Blind, Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of NTM-1632 vs Placebo Administered Intravenously in Healthy Adults
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03603665 -
A Study to Evaluate the Safety and Pharmacokinetics of NTM-1633 vs Placebo Administered Intravenously in Healthy Adults
|
Phase 1 | |
Not yet recruiting |
NCT04550793 -
Using Shear Wave Ultrasound Elastography for Follow up After Anti-spastic Intervention Among Stroke Patients
|
||
Completed |
NCT01441557 -
Pilot Study on the Usefulness of 3,4-diaminopyridine in the Treatment of Botulism
|
Phase 2/Phase 3 | |
Recruiting |
NCT05769478 -
Effect of Amifampridine on Neuromuscular Transmission in Patients Treated With OnabotulinumtoxinA
|
Phase 1 | |
Withdrawn |
NCT01940315 -
Phase 3, Randomized, Safety, Lot Consistency and Clinical Benefit Study of Recombinant Botulinum Vaccine A/B
|
Phase 3 | |
Enrolling by invitation |
NCT02051062 -
BT-011 Pharmacokinetics of Botulism Antitoxin Heptavalent in Pediatric Patients
|
Phase 4 | |
Completed |
NCT02055183 -
BT-010 Registry for the Evaluation of Safety and Clinical Outcomes in Patients Treated With Botulinum Antitoxin
|
||
Completed |
NCT01357213 -
Phase 1 PK Study of XOMA 3AB
|
Phase 1 | |
Completed |
NCT03676634 -
Tolerability and Immunogenicity of rBV A/B for the Production of BabyBIG®
|
Phase 2 | |
Completed |
NCT00314080 -
Treatment of Survivors After Botulism Outbreak
|
N/A | |
Not yet recruiting |
NCT06112834 -
Tolerability and Immunogenicity of a Single 40-ug Dose of rBV A/B for the Production of BabyBIG®
|
Phase 2 | |
Completed |
NCT00348426 -
Botulism Outbreak in Thailand (Episode II)
|
Phase 4 | |
Completed |
NCT00004401 -
Study of Human Botulism Immunoglobulin in Infants With Botulism
|
N/A | |
Completed |
NCT01701999 -
Safety, Tolerability, and Immunogenicity Study of Investigational Recombinant Botulinum Vaccine A/B (rBV A/B) in Volunteers Previously Immunized With Investigational Pentavalent Botulinum Toxoid
|
Phase 2 |