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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06223009 | Phase 1 Healthy Volunteer Burn Therapy Study | PHASE1 | COMPLETED | 32 | — | — | Jan 30, 2024 | Jul 23, 2024 | Nov 14, 2024 | 1 | United States |
Clinical safety laboratory data will be collected
| Arm | Type | Description |
|---|---|---|
| Single ascending doses of cNP8 | EXPERIMENTAL | Subjects will be randomized to receive either a single dose of cNP8 or placebo (6:2). The doses will be studied sequentially starting with the lowest cNP8 dose. |
| Single doses of placebo administered | PLACEBO_COMPARATOR | Subjects will be randomized to receive either a single dose of cNP8 or placebo (6:2). |
| Name | Type | Description |
|---|---|---|
| cNP8 | DRUG | cNP8 for injection is provided as a sterile lyophilizate for solution for infusion. Subjects will receive a single 30 minute IV infusion of cNP8 at their assigned dose. |
| Placebo | OTHER | Subjects not randomized to cNP8 will receive a single 30 minute IV infusion of placebo. |
Inclusion Criteria: * BMI between 18 kg/m2 to 32 kg/m2 and body weight of greater than or equal to 50 kg. * Use of highly-effective methods of birth control * Willing and able to remain in a clinical research unit for the required study duration and return for the outpatient visit Exclusion Criter...