NCT02779140

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

Completed Phase 1 Last updated 29 October 2018

What this trial tests

Phase 1 trial testing NTM-1632 in Botulism in 24 participants. Completed in 31 May 2017.

Timeline

1 August 2016

Primary endpoint
31 May 2017

31 May 2017

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	double
Primary purpose	treatment
Enrollment	24
Start date	1 August 2016
Primary completion	31 May 2017
Estimated completion	31 May 2017
Sites	1 location across United States

Drugs / interventions tested

• NTM-1632 — full drug profile →
• Placebo

Conditions studied

• Botulism — all drugs for Botulism →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 45, any sex, with Botulism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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 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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Exotoxin-Targeted Drug Modalities as Antibiotic Alternatives.
   Sakari M, Laisi A, Pulliainen AT. · · 2022 · cited 23× · PMID 35099182 · DOI 10.1021/acsinfecdis.1c00296
2. A new dawn for monoclonal antibodies against antimicrobial resistant bacteria.
   Troisi M, Marini E, Abbiento V, Stazzoni S, et al · · 2022 · cited 19× · PMID 36590399 · DOI 10.3389/fmicb.2022.1080059
3. Safety and Pharmacokinetics of a Four Monoclonal Antibody Combination Against Botulinum C and D Neurotoxins.
   Snow DM, Riling K, Kimbler A, Espinoza Y, et al · · 2019 · cited 16× · PMID 31591130 · DOI 10.1128/aac.01270-19
4. Safety, Tolerability, and Pharmacokinetics of NTM-1632, a Novel Mixture of Three Monoclonal Antibodies against Botulinum Toxin B.
   Guptill JT, Raja SM, Juel VC, Walter EB, et al · · 2021 · cited 13× · PMID 33875433 · DOI 10.1128/aac.02329-20
5. Monoclonal Antibodies as a Therapeutic Strategy against Multidrug-Resistant Bacterial Infections in a Post-COVID-19 Era.
   Chen HC, Pan YL, Chen Y, Yang TH, et al · · 2024 · cited 10× · PMID 38398755 · DOI 10.3390/life14020246
6. A Single Tri-Epitopic Antibody Virtually Recapitulates the Potency of a Combination of Three Monoclonal Antibodies in Neutralization of Botulinum Neurotoxin Serotype A.
   Lou J, Wen W, Conrad F, Meng Q, et al · · 2018 · cited 10× · PMID 29462889 · DOI 10.3390/toxins10020084
7. Emerging and Pandemic Pathogens: Lessons Learned From a Clinical Research Network.
   Atmar RL, Abate G, Deming ME, George SL, et al · · 2025 · cited 1× · PMID 41071737 · DOI 10.1093/cid/ciaf380