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Single ascending doses of cNP8 for Burns

Phase 1
Waitlist Available
Research Sponsored by Neomatrix Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
BMI between 18 kg/m2 to 32 kg/m2 and body weight of greater than or equal to 50 kg
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose, 0.25,0.50, 0.75,1,1.5, 2,4,6,12 hours postdose, day 2 and day 8 safety follow-up
Awards & highlights

Study Summary

This trial is testing a new drug to treat burns. It will involve healthy adult men and women who will receive either the investigational drug or a placebo. The study will last about 38 days,

Who is the study for?
This trial is for healthy adult men and women who are willing to participate in a study about burn treatment. They'll be observed in a clinical setting after receiving an intravenous dose of either the investigational drug cNP8 or a placebo.Check my eligibility
What is being tested?
The trial is testing the safety of cNP8, a new potential therapy for burns. Participants will be randomly assigned to receive either this drug or a placebo without knowing which one they're getting (double-blind).See study design
What are the potential side effects?
Since this is a first-in-human study, specific side effects of cNP8 are not yet known but may include typical reactions related to intravenous administration such as pain at injection site, fever, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My BMI is between 18 and 32, and I weigh at least 50 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose, 0.25,0.50, 0.75,1,1.5, 2,4,6,12 hours postdose, day 2 and day 8 safety follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose, 0.25,0.50, 0.75,1,1.5, 2,4,6,12 hours postdose, day 2 and day 8 safety follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and severity of adverse events from dosing through follow-up
Secondary outcome measures
Pharmacokinetic profile

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Single ascending doses of cNP8Experimental Treatment1 Intervention
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 II: Single doses of placebo administeredPlacebo Group1 Intervention
Subjects will be randomized to receive either a single dose of cNP8 or placebo (6:2).

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Neomatrix Therapeutics, Inc.Lead Sponsor
United States Department of DefenseFED
863 Previous Clinical Trials
227,600 Total Patients Enrolled
17 Trials studying Burns
1,491 Patients Enrolled for Burns

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals are eligible to participate in this clinical investigation?

"To be eligible for this clinical investigation, potential participants must have burn injuries and fall within the age range of 18 to 65. Approximately 32 individuals will be admitted into the study."

Answered by AI

Does this research include individuals who are above the age of 30?

"This clinical trial welcomes individuals who are of legal age and below 65 years old to participate."

Answered by AI

Are there any available positions for participants in this research study?

"According to the information provided on clinicaltrials.gov, this trial is not actively seeking participants. The initial posting was made on February 1st, 2024 and the latest update occurred on January 15th, 2024. However, it's important to note that there are currently 90 other ongoing studies actively recruiting patients at this time."

Answered by AI

What level of risk is associated with administering single escalating doses of cNP8 to patients?

"Given the limited data supporting safety and efficacy, Single ascending doses of cNP8 received a score of 1 on the scale from 1 to 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase 1 Healthy Volunteer Burn Therapy Study
2024. "Phase 1 Healthy Volunteer Burn Therapy Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06223009.
~13 spots leftby Jul 2024
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