Phase 1 Healthy Volunteer Burn Therapy Study

Burns Clinical Trial

Official title:

A First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Examine the Safety, Tolerability, and Pharmacokinetics of cNP8 in Healthy Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06223009
• Other study ID #: NMT-cNP8-101
• Secondary ID: HT9425-23-1-1064
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: February 2024
• Est. completion date: July 2024

Study information

• Verified date: January 2024
• Source: Neomatrix Therapeutics, Inc.
• Contact: Trisha Shamp, MD
• Phone: 651-641-2900
• Email: t.shamp[@]nucleusnetwork.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Burns

Intervention

Drug:
• cNP8
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.

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

Locations

Country	Name	City	State
United States	Nucleus Network	Saint Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Neomatrix Therapeutics, Inc.	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events from dosing through follow-up	Clinical safety laboratory data will be collected	Day -1, Day 2, Day 8 Safety Follow-up
Primary	Incidence and severity of adverse events from dosing through follow-up	Electrocardiograms will be performed	Day -1, 1 hour postdose, 6 hours postdose, Day 2 and Day 8 Safety Follow-up
Primary	Incidence and severity of adverse events from dosing through follow-up	Vital signs	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	Pharmacokinetic profile	Cmax	Predose, 0.25,0.50,0.75,1,1.5, 2,4,6,12 hours postdose