Phase I, Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of NTM-1632 (NCT02779140) | Clinical Trial Compass
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 range
18 Years – 45 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The occurrence of Adverse Events from administration of NTM-1632
Timeframe: Day 1 to 57
2
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
3
The occurrence of changes from baseline in ECG parameters post administration of NTM-1632
Timeframe: Screening, day 1
4
The occurrence of changes from baseline in physical examination following administration of NTM-1632
Timeframe: Screening, days -1, 1, 2
5
The occurrence of changes from baseline in vital signs following administration of NTM-1632