CompletedPhase 1

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

United States24 participantsStarted 2016-08-01

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 1\. Informed consent understood and signed 2. Healthy male or healthy, non-pregnant, non-lactating female 3. Willingness to comply and be available for all protocol procedures including inpatient confinement for 36-48 hours 4. Age between 18 and 45 years, inclusive on the day of infusion 5. Body Mass Index (BMI) of \>/=18.5 and \</=30 kg/m2 6. If the subject is female and of childbearing potential, she has a negative serum pregnancy test at screening and negative urine test within 24 hours prior to infusion. Note: A woman is considered of childbearing potential unless post-menopausal (\>/= 1 year without menses) or surgically sterilized via bilateral oophorectomy, or hysterectomy or bilateral tubal ligation or successful Essure placement with documented confirmation test at least 3 months after the procedure. 7. If the subject is female and of childbearing potential, she agrees to practice abstinence from sexual intercourse with men or use acceptable contraception, for up to visit 12 of the study. Note: Acceptable contraception methods are restricted to effective devices (Intrauterine Contraceptive Devices , NuvaRing®) or licensed hormonal products with use of method for a minimum of 28 days prior to dosing, condoms or diaphragm with spermicidal agents, monogamous relationship with a vasectomized partner. 8. The hemoglobin, platelet count, white blood cell count and absolute neutrophil count are within normal limits 9. The urine dipstick results on protei…

What they're measuring

The occurrence of Adverse Events from administration of NTM-1632

Timeframe: Day 1 to 57

The occurrence of changes from baseline in clinical safety laboratory values following administration of NTM-1632

Timeframe: Screening, days -1, 2, 4, 8, 15, 29, 91

The occurrence of changes from baseline in ECG parameters post administration of NTM-1632

Timeframe: Screening, day 1

The occurrence of changes from baseline in physical examination following administration of NTM-1632

Timeframe: Screening, days -1, 1, 2

The occurrence of changes from baseline in vital signs following administration of NTM-1632

Timeframe: Screening, days -1, 1, 2, 3, 4, 8, 15, 29, 43, 57, 91, 121

The occurrence of Serious Adverse Events following administration of NTM-1632

Timeframe: Day 1 to 121

Trial details

NCT IDNCT02779140

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2017-05-31

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