Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05308953 | A Phase I Safety Study of NVG-291 in Healthy Adults | PHASE1 | COMPLETED | 74 | — | — | May 6, 2021 | Jul 3, 2023 | Jan 10, 2024 | 1 | Australia |
number and frequency of adverse events
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| NVG-291 | DRUG | NVG-291 is a drug injected under the skin (subcutaneous). |
| Placebo | OTHER | Salt water is being used as a placebo and will be injected under the skin (subcutaneous). |
Inclusion Criteria: 1. Healthy subjects between 18 and 65 years old. 2. BMI between 18 and 33 kg/m2, inclusive, and a total body weight \> 50 kg. 3. All laboratory values must be within normal limits or any abnormalities deemed not clinically significant. 4. All subjects must be willing to abstain ...