A Safety, Tolerability and Pharmacokinetic Study of cP12 in Adults With Up To 10% Total Body Surface Area Burns
Recruiting
Phase 2
Interventional Study
Thermal Burns
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 6 (estimated)
- Sponsor
- Neomatrix Therapeutics, Inc. · Other
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About This Trial
This is a Phase 2a, open-label, single-dose study to evaluate the safety, tolerability, and PK profile of cP12 in 6 male and female subjects with thermal burns of up to and including 10% TBSA. Enrolled subjects must have at least 1% superficial (epidermal), superficial partial-thickness, or deep partial-thickness burns.
Eligible subjects will receive a single administration of 0.01 mg/kg cP12. Vi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* BMI between 18 kg/m2 (inclusive) and body weight \>/=50kg
* TBSA thermal burns up to and including 10%. The selected burn must be superficial (epidermal), superficial partial-thickness, or deep partial-thickness
* Able to be infused with cP12 within 2 to 24 hours post burn
* A…
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