Clinical trial NCT06223009: Phase 1 Healthy Volunteer Burn Therapy Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Burns
Lead sponsor: Neomatrix Therapeutics, Inc.
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2024-01-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence and severity of adverse events from dosing through follow-up
timeFrame: Day -1, Day 2, Day 8 Safety Follow-up
measure: Incidence and severity of adverse events from dosing through follow-up
timeFrame: Day -1, 1 hour postdose, 6 hours postdose, Day 2 and Day 8 Safety Follow-up
measure: Incidence and severity of adverse events from dosing through follow-up
timeFrame: 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:
measure: Pharmacokinetic profile
timeFrame: Predose, 0.25,0.50,0.75,1,1.5, 2,4,6,12 hours postdose
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Nucleus Network
state: Minnesota
Study officials:
References: