NCT05196373

Safety, Tolerability, Pharmacokinetics, Immunogenicity and Efficacy of STP705 in Adult Patients With Hypertrophic Scars

A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of STP705 Administered as Intrascar Injection in Adult Patients With Hypertrophic Scars

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Sirnaomics · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Adult patients with hypertrophic scars 30 Subjects in Dose Escalation 20 Subjects in Dose Expansion Intrascar injection of STP705 weekly for 4 weeks

Detailed description

An open label study design to evaluate the preliminary efficacy of STP705 in adult patients with hypertrophic scars. The study is divided into 2 stages: 1\. Dose Escalation: 30 subjects to be enrolled in this stage with a total of 6 dose groups. 3 subjects will be enrolled in 10ug and 20ug groups and 6 subjects in the subsequent groups of 40ug, 60ug, 80u and 100ug. 2\. Dose Expansion:1-2 dose groups will be selected and 20 subjects will be enrolled in each group.

Conditions

• Hypertrophic Scar

Interventions

Type	Name	Description
DRUG	STP705	STP705 Powder for Injection composed of siRNA-TGF-B1 and siRNA-COX-2 packged in a proprietary polymer nanoparticle formulation for delivery.

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2022-01-19
• Last updated: 2023-03-01

Regulatory

• FDA-regulated drug study