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A Randomized Study to Evaluate the Safety and Efficacy of Various Doses of STP705 in Subjects With Hypertrophic Scar

NCT02956317 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-11-24

No results posted yet for this study

Summary

This is a randomized, double-blind, within-subject placebo controlled study to evaluate the safety and efficacy of various doses of STP705 administered as intradermal Injection in subjects with hypertrophic scar. The goals are to determine the recommended Phase 2 dose, the pharmacokinetics and pharmacidynamics parameters, and conduct analysis of biomarkers common to the scar formation pathway.

Conditions

  • Hypertrophic Scar

Interventions

DRUG

STP705

The Cotsiranib drug substance is composed of two siRNA oligonucleotides, targeting TGF-β1 and Cox-2 mRNA respectively, and formulated in nanoparticles with Histidine-Lysine co-Polymer (HKP) peptide at a ratio of 1:4 in mass weight (siRNA:peptide), which is further formulated into a dry powder drug product. The administration route would be intra-dermal injection.

DRUG

Placebo

Normal Saline

Sponsors & Collaborators

  • Sirnaomics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02956317 on ClinicalTrials.gov