BotulismPhase 1NCT03603665
A Study to Evaluate the Safety and Pharmacokinetics of NTM-1633 vs Placebo Administered Intravenously in Healthy Adults
A Phase 1 study testing NTM-1633 in people with Botulism, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This is a Phase I, single-center, double-blind, placebo-controlled dose escalation trial of three dose cohorts (A: 0.033 mg/kg, B: 0.165 mg/kg, and C: 0.33 mg/kg). The purpose of this study is to evaluate the safety and tolerability of NTM-1633 in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Botulism
- What is being tested?
- NTM-1633
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2018to 11 Jun 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent understood and signed.
- Healthy male or healthy, non-pregnant, non-lactating female.
- Willingness to comply and be available for all protocol procedures including inpatient confinement for 36 - 48 hours.
- Age between 18 and 45 years, inclusive on the day of infusion.
- Body Mass Index (BMI) of > / =18.5 and < 35 kg/m^2.
- 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.
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- 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.
- If the subject is female and of childbearing potential, she agrees to practice abstinence from sexual intercourse with men or use acceptable contraception up to visit 12 of the study.
- Acceptable contraception methods are restricted to effective devices (Intrauterine Contraceptive Devices, NuvaRing(R)) 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
- The hemoglobin, platelet count, white blood cell count and absolute neutrophil count are within normal limits at the screening visit.
- The urine dipstick results on protein, glucose and blood are negative or trace.
- Menstruating females failing inclusion criteria due to a positive blood on urine dipstick may be retested following cessation of menses.
- Chemistry screening laboratory tests are in the normal reference range.
- The following exceptions to laboratory normal reference ranges are allowed: Creatinine, Blood Urea Nitrogen (BUN), total bilirubin, AST, ALT, lipase, amylase, Prothrombin Time (PT), Partial Thromboplastin Time (PTT) below the lower limit of normal (LLN); CK less than 400mg/ml; Glucose, potassium, total protein, and alkaline phosphatase with a toxicity grade of 1 is allowable; albumin above the upper limit of normal (ULN).
- Laboratory values that are outside the range of eligibility but are thought to be due to an acute condition or due to laboratory error may be repeated once.
- Abnormalities in mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW), mean platelet volume (MPV), and nucleated red blood cell count (NRBC CT), which are included in a complete blood count with differential, will not be exclusionary.
- Has adequate venous access for the infusion.
- The urine drug screen is negative.
- Breathalyzer test is negative.
- Available for follow-up for the duration of the study.
- Agrees not to participate in vigorous activity 72 hours prior to dosing through day 15 post dosing.
Who cannot join
- 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.
- 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)
- 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
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval > 450 milliseconds)
- Clinically significant abnormal electrocardiogram at screening.
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- 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
- Positive serology results for HIV, HBsAg, or HCV antibodies
- Febrile illness with temperature > 37.6 degrees Celsius within 7 days of dosing
- Pregnant or breastfeeding
- Donated blood within 56 days of enrollment (day -1)
- Known allergic reactions to any of the study product components present in the formulation or in the processing, as listed in the Investigator Brochure
- Treatment with another investigational drug within 28 days of dosing
- Treatment with a monoclonal antibody at any time in the past
- 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
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
- Use of H1 antihistamines or beta-blockers within 5 days of dosing
- Use of any prohibited medication within 28 days prior to study entry or planned use during the study period
- 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). If study activities overlap with the influenza season, subjects will be instructed to delay influenza vaccination until after Day 57 (Visit 11)
- Previous exposure to botulinum toxin, receipt of antibodies against botulinum toxin, or previous treatment with equine antitoxin
- Any previous injection or planned injection within 4 months after enrollment of botulinum toxin for cosmetic reasons, spastic dysphonia, torticollis, or any other reason
- Any specific condition that in the judgment of the investigator precludes participation because it could affect subject safety
- 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
- Includes trials that have a study intervention such as a drug, biologic, or device
- Is a study site employee or staff who are paid entirely or partially by the OCRR contract for the DMID-funded trial
- Site employees or staff include the PIs and sub-investigators or staff who are supervised by the PI or Sub-Investigators
- Systolic blood pressure >140 mm Hg or diastolic blood pressure > 90 mm Hg
- Resting heart rate < 50 or > 100 beats per minute at Screening
- Oral temperature > / = 38 degrees Celsius (100.4 degrees Fahrenheit)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University School of Medicine - Duke Clinical Research Institute - Duke Clinical Research Unit
Durham, North Carolina, 27710-4000
About this study
Official title: A Phase I, Double-Blind, Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of NTM-1633 vs Placebo Administered Intravenously in Healthy Adults
This is a Phase I, single-center, double-blind, placebo-controlled dose escalation trial of three dose cohorts (A: 0.033 mg/kg, B: 0.165 mg/kg, and C: 0.33 mg/kg). The purpose of this study is to evaluate the safety and tolerability of NTM-1633 in healthy adults. This is a first-in-human study consisting of three cohorts of eight subjects each. Dosing for each cohort is as follows: Two sentinel subjects will be administered a single 1-hour infusion (one NTM-1633, one placebo). No more than two subjects per day thereafter (at least 24 hrs will elapse between the dosing of each two subjects) will be dosed in the same manner until all subjects are dosed. Dose escalation will not occur until safety data through Day 8 is reviewed by the Safety Review Committee (SRC). Objective dose-escalation criteria and safety evaluations will be utilized. The study duration will be for approximately 8 months. Subjects in Cohort A will participate for approximately 17 weeks and Subjects in Cohorts B and C will participate approximately 21 weeks. Primary Objective: To assess the safety and tolerability of escalating doses of NTM-1633 administered intravenously in healthy adults.
Read the detailed description
This is a Phase I, single-center, double-blind, placebo-controlled dose escalation trial of three dose cohorts (A: 0.033 mg/kg, B: 0.165 mg/kg, and C: 0.33 mg/kg). The purpose of this study is to evaluate the safety and tolerability of NTM-1633 in healthy adults. This is a first-in-human study consisting of three cohorts of eight subjects each. Dosing for each cohort is as follows: Two sentinel subjects will be administered a single 1-hour infusion (one NTM-1633, one placebo). No more than two subjects per day thereafter (at least 24 hrs will elapse between the dosing of each two subjects) will be dosed in the same manner until all subjects are dosed. Dose escalation will not occur until safety data through Day 8 is reviewed by the Safety Review Committee (SRC). Objective dose-escalation criteria and safety evaluations will be utilized. The study duration will be for approximately 8 months. Subjects in Cohort A will participate for approximately 17 weeks and Subjects in Cohorts B and C will participate approximately 21 weeks. Primary Objective: To assess the safety and tolerability of escalating doses of NTM-1633 administered intravenously in healthy adults. Secondary Objectives: 1) To assess the pharmacokinetic characteristics of NTM-1633 following a single intravenous administration; 2) To assess the immunogenicity of NTM-1633 following a single intravenous administration.
- Conditions
- Botulism
- Being tested
- NTM-1633, Placebo
- Keywords
- Botulism, Dose Escalation, Double-Blind, NTM-1633, Pharmacokinetics, Phase I, Safety
- Medical subject headings
- Botulism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTM-1633Biological
NTM-1633 is an equimolar mixture of three IgG1 monoclonal antibodies (mAb), referred to as XE02, XE06, and XE17 which bind to non-overlapping epitopes on Botulinum Neurotoxin (BoNT/E). Administered as a single intravenous infusion of NTM-1633 over one hour.
PlaceboOther
0.9% Sodium Chloride Injection administered as a single intravenous infusion over one hour.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Single intravenous (IV) infusion of 0.033 mg/kg NTM-1633 (N=6) or matching Placebo (N=2) using an infusion pump over 60 minutes Receives: Biological: NTM-1633; Other: Placebo |
| Arm B | Experimental | Single IV infusion of 0.165 mg/kg NTM-1633 (N=6) or matching Placebo (N=2) using an infusion pump over 60 minutes Receives: Biological: NTM-1633; Other: Placebo |
| Arm C | Experimental | Single IV infusion of 0.330 mg/kg NTM-1633 (N=6) or matching Placebo (N=2) using an infusion pump over 60 minutes Receives: Biological: NTM-1633; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of AEs
Measured: From Day 1 through Day 57
The occurrence of changes in absolute neutrophil count
Measured: From Day -1 through Day 91
The occurrence of changes in alanine transaminase (ALT) level
Measured: From Day -1 through Day 91
The occurrence of changes in aldolase level
Measured: From Day -1 through Day 91
The occurrence of changes in alkaline phosphatase level
Measured: From Day -1 through Day 91
The occurrence of changes in aspartate transaminase (AST) level
Measured: From Day -1 through Day 91
The occurrence of changes in blood urea nitrogen (BUN) level
Measured: From Day -1 through Day 91
The occurrence of changes in calcium level
Measured: From Day -1 through Day 91
The occurrence of changes in Complete Blood Count (CBC) with differential
Measured: From Day -1 through Day 91
The occurrence of changes in diastolic blood pressure in arm A
Measured: From Day -1 through Day 91
The occurrence of changes in diastolic blood pressure in arms B and C
Measured: From Day -1 through Day 121
The occurrence of changes in direct bilirubin level
Measured: From Day -1 through Day 91
The occurrence of changes in heart rate in arm A
Measured: From Day -1 through Day 91
The occurrence of changes in heart rate in arms B and C
Measured: From Day -1 through Day 121
The occurrence of changes in hemoglobin level
Measured: From Day -1 through Day 91
The occurrence of changes in indirect bilirubin level
Measured: From Day -1 through Day 91
The occurrence of changes in oral temperature in arm A
Measured: From Day -1 through Day 91
The occurrence of changes in oral temperature in arms B and C
Measured: From Day -1 through Day 121
The occurrence of changes in physical examination in arm A
Measured: From Day -1 through Day 91
The occurrence of changes in physical examination in arms B and C
Measured: From Day -1 through Day 121
The occurrence of changes in platelet count
Measured: From Day -1 through Day 91
The occurrence of changes in potassium level
Measured: From Day -1 through Day 91
The occurrence of changes in prothrombin time/international normalized ratio (INR)
Measured: From Day -1 through Day 91
The occurrence of changes in serum creatinine level
Measured: From Day -1 through Day 91
The occurrence of changes in sodium level
Measured: From Day -1 through Day 91
The occurrence of changes in systolic blood pressure in arm A
Measured: From Day -1 through Day 91
The occurrence of changes in systolic blood pressure in arms B and C
Measured: From Day -1 through Day 121
The occurrence of changes in total bilirubin level
Measured: From Day -1 through Day 91
The occurrence of changes in total creatine kinase (CK) level
Measured: From Day -1 through Day 91
The occurrence of changes in White Blood Cell (WBC) count
Measured: From Day -1 through Day 91
The occurrence of clinically significant ECG abnormalities
Measured: From Day -28 through Day 1
The occurrence of QT interval abnormalities
Measured: From Day -28 through Day 1
The occurrence of SAEs in arm A
Measured: From Day 1 through Day 91
The occurrence of SAEs in arms B and C
Measured: From Day 1 through Day 121
The presence of protein, blood, or glucose in urine
Measured: From Day -1 through Day 91
Secondary outcomes (23)
Area under the plasma concentration-time curve (AUC) from time 0 up to the last observed concentration at time t (AUC0-t) for XE02 in arm A
Measured: From Day 1 through Day 91
Area under the plasma concentration-time curve (AUC) from time 0 up to the last observed concentration at time t (AUC0-t) for XE02 in arms B and C
Measured: From Day 1 through Day 121
Area under the plasma concentration-time curve (AUC) from time 0 up to the last observed concentration at time t (AUC0-t) for XE06 in arm A
Measured: From Day 1 through Day 91
Area under the plasma concentration-time curve (AUC) from time 0 up to the last observed concentration at time t (AUC0-t) for XE06 in arms B and C
Measured: From Day 1 through Day 121
Area under the plasma concentration-time curve (AUC) from time 0 up to the last observed concentration at time t (AUC0-t) for XE17 in arm A
Measured: From Day 1 through Day 91
Area under the plasma concentration-time curve (AUC) from time 0 up to the last observed concentration at time t (AUC0-t) for XE17 in arms B and C
Measured: From Day 1 through Day 121
Maximum observed plasma concentration (Cmax) for XE02 in arm A
Measured: From Day 1 through Day 91
Maximum observed plasma concentration (Cmax) for XE02 in arms B and C
Measured: From Day 1 through Day 121
Maximum observed plasma concentration (Cmax) for XE06 in arm A
Measured: From Day 1 through Day 91
Maximum observed plasma concentration (Cmax) for XE06 in arms B and C
Measured: From Day 1 through Day 121
Maximum observed plasma concentration (Cmax) for XE17 in arm A
Measured: From Day 1 through Day 91
Maximum observed plasma concentration (Cmax) for XE17 in arms B and C
Measured: From Day 1 through Day 121
The presence of human anti-human antibodies (HAHA)
Measured: Day 1
The presence of human anti-human antibodies (HAHA)
Measured: Day 29
The presence of human anti-human antibodies (HAHA)
Measured: Day 57
The presence of human anti-human antibodies (HAHA)
Measured: Day 91
The presence of human anti-human antibodies (HAHA) for Arms B and C
Measured: Day 121
Time to maximum observed plasma concentration (Tmax) for XE02 in arm A
Measured: From Day 1 through Day 91
Time to maximum observed plasma concentration (Tmax) for XE02 in arms B and C
Measured: From Day 1 through Day 121
Time to maximum observed plasma concentration (Tmax) for XE06 in arm A
Measured: From Day 1 through Day 91
Time to maximum observed plasma concentration (Tmax) for XE06 in arms B and C
Measured: From Day 1 through Day 121
Time to maximum observed plasma concentration (Tmax) for XE17 in arm A
Measured: From Day 1 through Day 91
Time to maximum observed plasma concentration (Tmax) for XE17 in arms B and C
Measured: From Day 1 through Day 121
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start25 Sep 2018
- Primary completion11 Jun 2019
- Study completion11 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BotulismStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603665
- Sponsor's protocol ID
- 14-0023
- Other IDs
- HHSN272201300017I
- Status last verified
- 17 Jul 2018
- First submitted
- 19 Jul 2018
- Last updated
- 22 Jun 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Double-Blind, Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of NTM-1633 vs Placebo Administered Intravenously in Healthy Adults
- ClinicalTrials.gov ID
- NCT03603665
- Acronym / sponsor ID
- 14-0023
- Conditions
- Botulism
- Keywords
- Botulism, Dose Escalation, Double-Blind, NTM-1633, Pharmacokinetics, Phase I, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 11 Jun 2019 (actual)
- Study completion
- 11 Jun 2019 (actual)
- First posted
- 27 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I, single-center, double-blind, placebo-controlled dose escalation trial of three dose cohorts (A: 0.033 mg/kg, B: 0.165 mg/kg, and C: 0.33 mg/kg). The purpose of this study is to evaluate the safety and tolerability of NTM-1633 in healthy adults. This is a first-in-human study consisting of three cohorts of eight subjects each. Dosing for each cohort is as follows: Two sentinel subjects will be administered a single 1-hour infusion (one NTM-1633, one placebo). No more than two subjects per day thereafter (at least 24 hrs will elapse between the dosing of each two subjects) will be dosed in the same manner until all subjects are dosed. Dose escalation will not occur until safety data through Day 8 is reviewed by the Safety Review Committee (SRC). Objective dose-escalation criteria and safety evaluations will be utilized. The study duration will be for approximately 8 months. Subjects in Cohort A will participate for approximately 17 weeks and Subjects in Cohorts B and C will participate approximately 21 weeks. Primary Objective: To assess the safety and tolerability of escalating doses of NTM-1633 administered intravenously in healthy adults.
Detailed description
This is a Phase I, single-center, double-blind, placebo-controlled dose escalation trial of three dose cohorts (A: 0.033 mg/kg, B: 0.165 mg/kg, and C: 0.33 mg/kg). The purpose of this study is to evaluate the safety and tolerability of NTM-1633 in healthy adults. This is a first-in-human study consisting of three cohorts of eight subjects each. Dosing for each cohort is as follows: Two sentinel subjects will be administered a single 1-hour infusion (one NTM-1633, one placebo). No more than two subjects per day thereafter (at least 24 hrs will elapse between the dosing of each two subjects) will be dosed in the same manner until all subjects are dosed. Dose escalation will not occur until safety data through Day 8 is reviewed by the Safety Review Committee (SRC). Objective dose-escalation criteria and safety evaluations will be utilized. The study duration will be for approximately 8 months. Subjects in Cohort A will participate for approximately 17 weeks and Subjects in Cohorts B and C will participate approximately 21 weeks. Primary Objective: To assess the safety and tolerability of escalating doses of NTM-1633 administered intravenously in healthy adults. Secondary Objectives: 1) To assess the pharmacokinetic characteristics of NTM-1633 following a single intravenous administration; 2) To assess the immunogenicity of NTM-1633 following a single intravenous administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Biological: NTM-1633, Other: PlaceboSingle intravenous (IV) infusion of 0.033 mg/kg NTM-1633 (N=6) or matching Placebo (N=2) using an infusion pump over 60 minutes |
| Arm B | Experimental | Biological: NTM-1633, Other: PlaceboSingle IV infusion of 0.165 mg/kg NTM-1633 (N=6) or matching Placebo (N=2) using an infusion pump over 60 minutes |
| Arm C | Experimental | Biological: NTM-1633, Other: PlaceboSingle IV infusion of 0.330 mg/kg NTM-1633 (N=6) or matching Placebo (N=2) using an infusion pump over 60 minutes |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Informed consent understood and signed.
- Healthy male or healthy, non-pregnant, non-lactating female.
- Willingness to comply and be available for all protocol procedures including inpatient confinement for 36 - 48 hours.
- Age between 18 and 45 years, inclusive on the day of infusion.
- Body Mass Index (BMI) of > / =18.5 and < 35 kg/m^2.
Key exclusion criteria (29 listed)
- 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.
- History of severe allergic reaction of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobulins.
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval > 450 milliseconds)
- Clinically significant abnormal electrocardiogram at screening.
- Positive serology results for HIV, HBsAg, or HCV antibodies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTM-1633NTM-1633 is an equimolar mixture of three IgG1 monoclonal antibodies (mAb), referred to as XE02, XE06, and XE17 which bind to non-overlapping epitopes on Botulinum Neurotoxin (BoNT/E). Administered as a single intravenous infusion of NTM-1633 over one hour. | Biological | Arm A, Arm B, Arm C |
| Placebo0.9% Sodium Chloride Injection administered as a single intravenous infusion over one hour. | Other | Arm A, Arm B, Arm C |
Primary outcome
The occurrence of AEs
Time frame: From Day 1 through Day 57
The occurrence of changes in absolute neutrophil count
Time frame: From Day -1 through Day 91
The occurrence of changes in alanine transaminase (ALT) level
Time frame: From Day -1 through Day 91
The occurrence of changes in aldolase level
Time frame: From Day -1 through Day 91
The occurrence of changes in alkaline phosphatase level
Time frame: From Day -1 through Day 91
The occurrence of changes in aspartate transaminase (AST) level
Time frame: From Day -1 through Day 91
The occurrence of changes in blood urea nitrogen (BUN) level
Time frame: From Day -1 through Day 91
The occurrence of changes in calcium level
Time frame: From Day -1 through Day 91
The occurrence of changes in Complete Blood Count (CBC) with differential
Time frame: From Day -1 through Day 91
The occurrence of changes in diastolic blood pressure in arm A
Time frame: From Day -1 through Day 91
The occurrence of changes in diastolic blood pressure in arms B and C
Time frame: From Day -1 through Day 121
The occurrence of changes in direct bilirubin level
Time frame: From Day -1 through Day 91
The occurrence of changes in heart rate in arm A
Time frame: From Day -1 through Day 91
The occurrence of changes in heart rate in arms B and C
Time frame: From Day -1 through Day 121
The occurrence of changes in hemoglobin level
Time frame: From Day -1 through Day 91
The occurrence of changes in indirect bilirubin level
Time frame: From Day -1 through Day 91
The occurrence of changes in oral temperature in arm A
Time frame: From Day -1 through Day 91
The occurrence of changes in oral temperature in arms B and C
Time frame: From Day -1 through Day 121
The occurrence of changes in physical examination in arm A
Time frame: From Day -1 through Day 91
The occurrence of changes in physical examination in arms B and C
Time frame: From Day -1 through Day 121
The occurrence of changes in platelet count
Time frame: From Day -1 through Day 91
The occurrence of changes in potassium level
Time frame: From Day -1 through Day 91
The occurrence of changes in prothrombin time/international normalized ratio (INR)
Time frame: From Day -1 through Day 91
The occurrence of changes in serum creatinine level
Time frame: From Day -1 through Day 91
The occurrence of changes in sodium level
Time frame: From Day -1 through Day 91
The occurrence of changes in systolic blood pressure in arm A
Time frame: From Day -1 through Day 91
The occurrence of changes in systolic blood pressure in arms B and C
Time frame: From Day -1 through Day 121
The occurrence of changes in total bilirubin level
Time frame: From Day -1 through Day 91
The occurrence of changes in total creatine kinase (CK) level
Time frame: From Day -1 through Day 91
The occurrence of changes in White Blood Cell (WBC) count
Time frame: From Day -1 through Day 91
The occurrence of clinically significant ECG abnormalities
Time frame: From Day -28 through Day 1
The occurrence of QT interval abnormalities
Time frame: From Day -28 through Day 1
The occurrence of SAEs in arm A
Time frame: From Day 1 through Day 91
The occurrence of SAEs in arms B and C
Time frame: From Day 1 through Day 121
The presence of protein, blood, or glucose in urine
Time frame: From Day -1 through Day 91
23 secondary outcomes
Area under the plasma concentration-time curve (AUC) from time 0 up to the last observed concentration at time t (AUC0-t) for XE02 in arm A
Time frame: From Day 1 through Day 91
Area under the plasma concentration-time curve (AUC) from time 0 up to the last observed concentration at time t (AUC0-t) for XE02 in arms B and C
Time frame: From Day 1 through Day 121
Area under the plasma concentration-time curve (AUC) from time 0 up to the last observed concentration at time t (AUC0-t) for XE06 in arm A
Time frame: From Day 1 through Day 91
Area under the plasma concentration-time curve (AUC) from time 0 up to the last observed concentration at time t (AUC0-t) for XE06 in arms B and C
Time frame: From Day 1 through Day 121
Area under the plasma concentration-time curve (AUC) from time 0 up to the last observed concentration at time t (AUC0-t) for XE17 in arm A
Time frame: From Day 1 through Day 91
Area under the plasma concentration-time curve (AUC) from time 0 up to the last observed concentration at time t (AUC0-t) for XE17 in arms B and C
Time frame: From Day 1 through Day 121
Maximum observed plasma concentration (Cmax) for XE02 in arm A
Time frame: From Day 1 through Day 91
Maximum observed plasma concentration (Cmax) for XE02 in arms B and C
Time frame: From Day 1 through Day 121
Maximum observed plasma concentration (Cmax) for XE06 in arm A
Time frame: From Day 1 through Day 91
Maximum observed plasma concentration (Cmax) for XE06 in arms B and C
Time frame: From Day 1 through Day 121
Maximum observed plasma concentration (Cmax) for XE17 in arm A
Time frame: From Day 1 through Day 91
Maximum observed plasma concentration (Cmax) for XE17 in arms B and C
Time frame: From Day 1 through Day 121
The presence of human anti-human antibodies (HAHA)
Time frame: Day 1
The presence of human anti-human antibodies (HAHA)
Time frame: Day 29
The presence of human anti-human antibodies (HAHA)
Time frame: Day 57
The presence of human anti-human antibodies (HAHA)
Time frame: Day 91
The presence of human anti-human antibodies (HAHA) for Arms B and C
Time frame: Day 121
Time to maximum observed plasma concentration (Tmax) for XE02 in arm A
Time frame: From Day 1 through Day 91
Time to maximum observed plasma concentration (Tmax) for XE02 in arms B and C
Time frame: From Day 1 through Day 121
Time to maximum observed plasma concentration (Tmax) for XE06 in arm A
Time frame: From Day 1 through Day 91
Time to maximum observed plasma concentration (Tmax) for XE06 in arms B and C
Time frame: From Day 1 through Day 121
Time to maximum observed plasma concentration (Tmax) for XE17 in arm A
Time frame: From Day 1 through Day 91
Time to maximum observed plasma concentration (Tmax) for XE17 in arms B and C
Time frame: From Day 1 through Day 121
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NTM-1633 in people with Botulism, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of AEs (time frame: From Day 1 through Day 57). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.