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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04540900 | A Phase I Study of KB301, a Replication-Incompetent, Non-Integrating Vector Expressing Human Type III Collagen (COL3) for the Treatment of Superficial Skin Depressions | PHASE1 | ACTIVE NOT_RECRUITING | 85 | — | — | Oct 7, 2020 | May 31, 2029 | May 13, 2025 | 4 | United States |
The primary outcome will look at the safety and tolerability of KB301 through the collection and quantification of adverse events, physical examinations, vital signs and clinical laboratory tests.
| Arm | Type | Description |
|---|---|---|
| KB301 | ACTIVE_COMPARATOR | non-integrating HSV-1 vector expressing human type III collagen |
| Placebo | PLACEBO_COMPARATOR | sterile isotonic saline |
| Name | Type | Description |
|---|---|---|
| KB301 | BIOLOGICAL | non-integrating HSV-1 vector expressing human type III collagen |
| Placebo | OTHER | sterile isotonic saline |
Inclusion Criteria: 1. Male or female in good general health, as determined by the investigator, aged ≥18 and ≤75 at the time of consent (only females for Cohort 4) 2. Regions of suitable skin to be selected as Target Area(s), as determined by a physical examination conducted by the investigator du...