Phase 1 Healthy Volunteer Burn Therapy Study

NCT06223009 | Completed Phase 1 FDA Drug

• 2 other identifiers: NMT-cNP8-101HT9425-23-1-1064
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Pharmacokinetic profile

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

Study Arms (2)

Single ascending doses of cNP8

EXPERIMENTAL

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.

Drug: cNP8

Single doses of placebo administered

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

cNP8 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 ascending doses of cNP8

Placebo OTHER

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

Single doses of placebo administered

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neomatrix Therapeutics, Inc.: lead
• United States Department of Defense: collaborator

Study Sites (1)

Nucleus Network

Saint Paul, Minnesota, 55114, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 25, 2024
• Study Start: January 30, 2024
• Primary Completion: May 6, 2024
• Study Completion: July 23, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

US (1)