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This is a randomized, triple-blind (subjects, Investigators, and Sponsor blinded), placebo-controlled Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study to evaluate the safety and tolerability of NVG-291 administered by subcutaneous injection daily in healthy female participants. The trial is split into three parts, starting with Part 1 (SAD), then Part 2 (MAD - post-menopausal Females), and finally Part 3 (MAD - males and premenopausal females). In Part 1 (SAD), participants receive 1 dose on 1 day only and in Parts 2 and 3, participants receive 1 dose every day for 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVG-291 SAD | Experimental | Doses will begin at the lowest dose level in Cohort 1, increasing in dose with each subsequent cohort to the highest dose level in Cohort 6 or until a maximum tolerated dose (MTD) is reached. |
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| NVG-291 MAD | Experimental | Participants will receive 1 dose daily for for 14 consecutive days. The maximum starting dose for MAD will be 2 dose levels lower than the maximum dose achieved during SAD. There will be a maximum of 3 dosing cohorts in Part 2. The maximum daily dose in Part 2 will not exceed the maximum daily dose tolerated in Part 1. |
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| NVG-291 MAD - Males and Premenopausal Females | Experimental | Participants will receive 1 dose daily for for 14 consecutive days. The dose maximum daily dose in Part 3 will not exceed the maximum daily dose tolerated in either Part 1 or 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVG-291 | Drug | NVG-291 is a drug injected under the skin (subcutaneous). |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | number and frequency of adverse events | Assessed through 7 days following the last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic analysis (plasma) | measure of concentration of drug in blood plasma | Assessed on Day 1 (SAD and MAD) and Day 14 (MAD only) |
| Immunogenicity analysis | number of participants with confirmed and titer results for the presence of anti-drug antibodies |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Miko, MD | CMO | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Networks | Melbourne | Victoria | 3004 | Australia |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Placebo | Other | Salt water is being used as a placebo and will be injected under the skin (subcutaneous). |
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| Assessed on Day 1 (SAD and MAD), Day 8 (SAD and MAD) and Day 21 (MAD only) |
| D014947 | Wounds and Injuries |