Phase 1 Healthy Volunteer Burn Therapy Study

Completed · Phase 1 · Has a placebo group

Conditions studied: Burns

In brief

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.

Key facts

Study ID

NCT06223009

Run by

Neomatrix Therapeutics, Inc.

People needed

32

Starts

2024-01-30

Expected to finish

2024-07-23

Last updated by the study team

2024-11-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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 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

Where it is running

• Nucleus Network — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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