Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628037
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
SN514-066b Enzyme in Deep Partial Thickness Burns
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Maximum Tolerated Dose Study of SN514-066b in Adult Patients with Deep Partial Thickness Dermal Burns
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the tolerability of a gel formulation of the enzyme SN514 in patients with burns suitable for enzymatic debridement In a rising dose fashion by sequential cohort concentrations of 01 02 04 and 08 will be tested Groups of 3 will undergo daily debridement for up to 7 days Extent of debridement and adverse signs and symptoms will be recorded daily Dose escalation will stop if a dose level is found to be intolerable Dose escalation may accelerate if a tested dose is entirely ineffective There is no placebo control as all burn wounds require debridement
Detailed Description:
The design of the study is a sequential rising dose to the maximum tolerated dose in which each subject will be exposed to only one concentration of the test article Dose limiting toxicities are defined as Severe or CTCAE v5 Grade 3 or higher adverse events This study in burn patients is designed to apply SN514-066b over 25 cm2 014 TBSA for a 173 m2 adult up to 500 cm2 29 at sequentially rising concentrations of 01 02 04 and 08 lt 10 mgcm2 The highest exposure would be 08 8 g per 100 cc of gel over 29 of 173 m2 800 mg or 114 mgkg applied topically 70 kg patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None