Burns
Conditions
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.
Interventions
DRUGcNP8
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.
OTHERPlacebo
Subjects not randomized to cNP8 will receive a single 30 minute IV infusion of placebo.
Sponsors
United States Department of Defense
Neomatrix Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events from dosing through follow-up | Day -1, Day 2, Day 8 Safety Follow-up | Clinical safety laboratory data will be collected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic profile | Predose, 0.25,0.50,0.75,1,1.5, 2,4,6,12 hours postdose | Cmax |
Countries
United States
Outcome results
None listed