Phase 1 Healthy Volunteer Burn Therapy Study

Neomatrix Therapeutics, Inc.32 enrolled

Overview

This is a Phase 1, single-center, randomized, double-blind, placebo-controlled, first-in-human study to evaluate the safety of an investigational drug to treat burns. Participants will be healthy male and female adults. The study will consist of a screening period, inpatient dosing and observation period and safety follow-up. Participants will receive 1 intravenous dose of the investigational drug or placebo. Duration of participation will be approximately 38 days, which includes a maximum of a 30 day screening period and a study period of approximately 8 days.

Up to 32 healthy, male and female subjects will be enrolled in this Phase 1, single-center, randomized, double-blind, placebo-controlled, first-in-human study. Eligible subjects will be confined to a Phase 1 unit for approximately 48 hours and receive a one time IV dose of study medication. They will be required to return for a safety follow-up visit one week later. Doses will be studied sequentially starting with the lowest dose of the investigational drug, cNP8. Each dose cohort will include a total of 6 subjects dosed with cNP8 and 2 subjects dosed with placebo. A sentinel dosing plan with staggered enrollment will be employed. For each dosing cohort, 2 subjects will be dosed (1 with cNP8 and 1 with placebo) and monitored for serious and/or severe adverse events (AEs). If no serious or severe AEs occur in 24 hours postdose, the remaining 6 subjects in the cohort will be dosed. Safety evaluations, including laboratory tests, vital sign measurements and electrocardiograms, will be performed at several timepoints throughout the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Burns

Interventions

cNP8DRUG

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.

PlaceboOTHER

Subjects not randomized to cNP8 will receive a single 30 minute IV infusion of placebo.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 Criteria: * A clinically significant laboratory abnormality or other finding indicative of a clinically-significant exclusionary disease * A history of asymptomatic or mild COVID within 30 days of study drug administration * A history of hospitalization with COVID within 6 months prior to study drug administration * A history of COVID vaccination within 1 month prior to study drug administration

Locations (1)

Nucleus Network

Saint Paul, Minnesota, United States

Outcomes

Primary Outcomes

Incidence and severity of adverse events from dosing through follow-up

Clinical safety laboratory data will be collected

Time frame: Day -1, Day 2, Day 8 Safety Follow-up

Incidence and severity of adverse events from dosing through follow-up

Electrocardiograms will be performed

Time frame: Day -1, 1 hour postdose, 6 hours postdose, Day 2 and Day 8 Safety Follow-up

Incidence and severity of adverse events from dosing through follow-up

Vital signs

Time frame: Predose, 0.25,0.50, 0.75,1,1.5, 2,4,6,12 hours postdose, Day 2 and Day 8 Safety Follow-up

Secondary Outcomes

Pharmacokinetic profile

Cmax

Time frame: Predose, 0.25,0.50,0.75,1,1.5, 2,4,6,12 hours postdose

Data from ClinicalTrials.gov

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