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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2017-05-31

Brief Summary

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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.

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Detailed Description

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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

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Botulism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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0.033 mg/kg NTM-1632

N=6 administered 0.033 mg/kg NTM-1632 IV, N=2 administered placebo IV

Group Type EXPERIMENTAL

NTM-1632

Intervention Type BIOLOGICAL

Monoclonal antibody mixture of XB10, XB18, and XB23

Placebo

Intervention Type OTHER

Placebo

0.165 mg/kg NTM-1632

N=6 administered 0.165 mg/kg NTM-1632 IV, N=2 administered placebo IV

Group Type EXPERIMENTAL

NTM-1632

Intervention Type BIOLOGICAL

Monoclonal antibody mixture of XB10, XB18, and XB23

Placebo

Intervention Type OTHER

Placebo

0.33 mg/kg NTM-1632

N=6 administered 0.33 mg/kg NTM-1632 IV, N=2 administered placebo IV

Group Type EXPERIMENTAL

NTM-1632

Intervention Type BIOLOGICAL

Monoclonal antibody mixture of XB10, XB18, and XB23

Placebo

Intervention Type OTHER

Placebo

Interventions

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NTM-1632

Monoclonal antibody mixture of XB10, XB18, and XB23

Intervention Type BIOLOGICAL

Placebo

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

1\. History of a chronic medical condition that would either interfere with the accurate assessment of the objectives of the study or increase the risk profile of the subject. Note: Chronic medical conditions include diabetes; Asthma requiring use of medication in the year before screening; Autoimmune disorder such as lupus, Wegener's, rheumatoid arthritis, thyroid disease; Coronary artery disease; Chronic hypertension; History of malignancy except low-grade (squamous and basal cell) skin cancer thought to be cured; chronic renal, hepatic, pulmonary, or endocrine disease (except previous asthma which has required no treatment for the past year); 2. History of severe allergic reaction of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobulins. Note: Severe allergic reaction is defined as any of the following: anaphylaxis, urticaria, or angioedema 3. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 milliseconds) 4. Clinically significant abnormal electrocardiogram at screening. Note: Clinically significant abnormal ECG results include: complete left or right bundle branch block; other ventricular conduction block; 2nd degree or 3rd degree atrioventricular (AV) block; sustained ventricular arrhythmia; sustained atrial arrhythmia; two Premature Ventricular Contractions in a row; pattern of ST elevation felt consistent with cardiac ischemia; or any condition deemed clinically significant by a study investigator 5. Positive serology results for HIV, HBsAg, or HCV antibodies 6. Febrile illness with temperature \>37.6°C within 7 days of dosing 7. Pregnant or breastfeeding 8. Donated blood within 56 days of enrollment 9. Known allergic reactions to any of the study product components present in the formulation or in the processing, as listed in the Investigator Brochure 10. Treatment with another investigational drug within 28 days of dosing 11. Treatment with a monoclonal antibody at any time in the past 12. Receipt of antibody (e.g. TIG, VZIG, IVIG, IM gamma globulin) or blood transfusion within 6 months or within 5 half-lives of the specific product given 13. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements 14. Use of H1 antihistamines or beta-blockers within 5 days of dosing 15. Use of any prohibited medication within 28 days prior to study entry or planned use during the study period Note: Prohibited medications include immunosuppressives (except Nonsteroidal Anti-Inflammatory Drugs \[NSAIDS\]); immune modulators; oral corticosteroids (topical/intranasal steroids are acceptable); anti-neoplastic agents; any vaccine (licensed or investigational) 16. Previous exposure to botulinum toxin, receipt of antibodies against botulinum toxin, or previous treatment with equine antitoxin 17. Any previous injection or planned injection within 4 months after enrollment of botulinum toxin for cosmetic reasons, spastic dysphonia, torticollis, or any other reason 18. Any specific condition that in the judgment of the investigator precludes participation because it could affect subject safety 19. Plans to enroll or is already enrolled in another clinical trial\* that could interfere with safety assessment of the investigational product at any time during the study period. Note: Includes trials that have a study intervention such as a drug, biologic, or device 20. Is a study site employee or staff who are paid entirely or partially by the OCRR contract for the DMID-funded trial. Note: Site employees or staff include the PIs and sub-investigators or staff who are supervised by the PI or Sub-Investigators 21. Systolic blood pressure \>140 mm Hg or diastolic blood pressure \>90 mm Hg 22. Resting heart rate \<50 or \>100 beats per minute 23. Oral temperature = 38°C (100.4°F)

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes