Phase 1 Healthy Volunteer Burn Therapy Study

NCT ID: NCT06223009

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-30
• Study Completion Date: 2024-07-23

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.

Conditions

Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Single ascending doses of 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.

Group Type: EXPERIMENTAL

cNP8

Intervention Type: DRUG

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.

Single doses of placebo administered

Subjects will be randomized to receive either a single dose of cNP8 or placebo (6:2).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Neomatrix Therapeutics, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nucleus Network

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

HT9425-23-1-1064

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NMT-cNP8-101

Identifier Type: -

Identifier Source: org_study_id