Phase 1 Healthy Volunteer Burn Therapy Study

Phase 1

Completed

• Conditions: Burns
• Interventions: Drug: cNP8; Other: Placebo

• Registration Number: NCT06223009
• Lead Sponsor: Neomatrix Therapeutics, Inc.

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-15
• Study First Posted: 2024-01-25
• Study Start: 2024-01-30
• Primary Completion: 2024-05-06
• Study Completion: 2024-07-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single ascending doses of cNP8	cNP8	Subjects will be randomized to receive either a single dose of cNP8 or placebo (6:2). The doses will be studied sequentially starting with the lowest cNP8 dose.
Single doses of placebo administered	Placebo	Subjects will be randomized to receive either a single dose of cNP8 or placebo (6:2).

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events from dosing through follow-up	Predose, 0.25,0.50, 0.75,1,1.5, 2,4,6,12 hours postdose, Day 2 and Day 8 Safety Follow-up	Vital signs

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic profile	Predose, 0.25,0.50,0.75,1,1.5, 2,4,6,12 hours postdose	Cmax

Trial Locations

Locations (1)

Nucleus Network; 🇺🇸 Saint Paul, Minnesota, United States