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The purpose of this study is to evaluate the safety and tolerability of N6022 in healthy subjects.
This is a single dose escalation, first-time-in-human study with three ascending cohorts. Eligible subjects will receive a single dose of investigational medicinal product or placebo on Day 1 and will be followed for safety, PK, and PD for 72 hours post dose. Follow-up visits on Day 4 and Day 7 for the end-of-study safety. Participation of an individual subject may last up to 36 days from the time of screening until the end-of-study follow-up visit. Each cohort will enroll a sentinel pair (1:1 randomized to active: placebo). These subjects will be followed for 48 hours postdose and safety data reviewed before the remaining subjects in the cohort receive IMP. A Safety Monitoring Committee will review the seven-day safety data in each cohort before proceeding to the next ascending dose cohort, according to the stopping rules outlined in the protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | N6022 |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N6022 | Drug | This is an injectible formulation which will be given at 5, 15 & 45 mg over 1, 3 and 9 minutes respectively, in single ascending doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of a Single Ascending Doses of Intravenous N6022 in Healthy Volunteers | Safety variables - number of adverse events reported during study, changes in vital signs, physical examination findings, telemetry alerts, 12-lead ECG changes, infusion site reactions, O2 saturation changes, and clinical laboratory assessment changes between subjects receiving N6022 versus placebo. | 7 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum N6022 and Metabolite Concentrations in Plasma Within 24 Hours of End of Administration | Concentrations of N6022 and metabolite [N61149)], collected on Days 1 and 7; predose, end of infusion, and at 10 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 16, and 24 hours post-dose (the 24 hour postdose collected prior to the start of infusion on Day 2). | 24 hours |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Goldwater, MDCM, MSc(A) | Parexel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel Early Phase Unit | Baltimore | Maryland | 21225 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | 5 mg of N6022 was given intravenously daily for 7 days |
| FG001 | Cohorts 2 and 4 | 15 mg of N6022 was given intravenously daily for 7 days |
| FG002 | Cohort 3 | 45 mg of N6022 was to be given intravenously daily for 7 days however, the actual amount was 27.5 mg. |
| FG003 | Cohort 5 | 25 mg of N6022 was given intravenously daily for 7 days |
| FG004 | Cohort 6 | 35 mg of N6022 was given intravenously daily for 7 days |
| FG005 | Placebo | Not Active - Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Any subject that received any active or placebo
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | N6022 - Active 5 mg |
| BG001 | Cohort 2 & 4 | N6022 - Active 15 mg |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety and Tolerability of a Single Ascending Doses of Intravenous N6022 in Healthy Volunteers | Safety variables - number of adverse events reported during study, changes in vital signs, physical examination findings, telemetry alerts, 12-lead ECG changes, infusion site reactions, O2 saturation changes, and clinical laboratory assessment changes between subjects receiving N6022 versus placebo. | Any subject that received active IMP or placebo | Posted | Number | Adverse Events | 7 Days |
|
6 months and 2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | N6022 - Active 5 mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment | and administration site conditions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janice M Troha | N30 Pharmaceuticals Inc. | 720-945-7714 | janice.troha@n30pharma.com |
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| ID | Term |
|---|---|
| C571360 | N6022 |
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| Placebo | Drug | This will be 0.9% normal saline given over 1, 3, or 9 minutes IV bolus. |
|
|
| Cohort 3 |
N6022 - Active 45 mg (actual *27.5 mg) |
| BG003 | Cohort 5 | N6022 - Active 25 mg |
| BG004 | Cohort 6 | N6022 - Active 35 mg |
| BG005 | Placebo | Not Active - Placebo |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Cohort 3 | N6022 - Active 45 mg |
| OG003 | Cohort 5 | N6022 - Active 25 mg |
| OG004 | Cohort 6 | N6022 - Active 35 mg |
| OG005 | Placebo | Not Active - Placebo |
|
|
| Secondary | Maximum N6022 and Metabolite Concentrations in Plasma Within 24 Hours of End of Administration | Concentrations of N6022 and metabolite [N61149)], collected on Days 1 and 7; predose, end of infusion, and at 10 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 16, and 24 hours post-dose (the 24 hour postdose collected prior to the start of infusion on Day 2). | Any subject that received the active IMP or placebo | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 24 hours |
|
|
|
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | Cohort 2 and 4 | N6022 - Active 15 mg | 0 | 12 | 4 | 12 |
| EG002 | Cohort 3 | N6022 - Active 45 mg | 0 | 1 | 1 | 1 |
| EG003 | Cohort 5 | N6022 - Active 25 mg | 0 | 6 | 0 | 6 |
| EG004 | Cohort 6 | N6022 - Active 35 mg | 0 | 6 | 1 | 6 |
| EG005 | Placebo | Not Active - Placebo | 0 | 10 | 2 | 6 |
|
| Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection Site Hematoma | General disorders | MedDRA (Unspecified) | Systematic Assessment | and administration site conditions |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment | administration and site conditions |
|
| Sinus Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dry Throat | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
The investigator agrees with the use of results of the clinical study for the purposes of national and international registration, publication, and information for medical and pharmaceutical professionals. If necessary, the competent authorities will be notified of the investigator's name, address, qualifications, and extent of involvement. An investigator shall not publish any data (poster, abstract, paper, etc.) without having consulted with the Sponsor in advance.