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cNP8

Phase 1

Burns | Small molecule | Dermatology |United Therapeutics Corporation|Last Updated: Nov 14, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

cNP8 · 1 trial · 1 indication

Phase 1 1
NCT06223009Phase 1 Healthy Volunteer Burn Therapy StudyBurns
COMPLETED32 Analytics
PHASE1COMPLETED
Phase 1 Healthy Volunteer Burn Therapy Study
BurnsUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

Pharmacokinetic profile
Predose, 0.25,0.50,0.75,1,1.5, 2,4,6,12 hours postdose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single ascending doses of cNP8EXPERIMENTALSubjects 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.
Single doses of placebo administeredPLACEBO_COMPARATORSubjects will be randomized to receive either a single dose of cNP8 or placebo (6:2).

Interventions

NameTypeDescription
cNP8DRUGcNP8 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.
PlaceboOTHERSubjects not randomized to cNP8 will receive a single 30 minute IV infusion of placebo.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 Criter...

Countries:United States
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Frequently asked questions about cNP8

What is cNP8 used for?

cNP8 is an investigational small molecule being developed for the treatment of burns. It is currently in Phase 1 clinical development, with a completed trial in healthy volunteers to evaluate its safety and tolerability. The drug is being studied in the United States.

Who makes cNP8?

cNP8 is being developed by United Therapeutics Corporation, a biotechnology company traded on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical research on this investigational small molecule for the treatment of burns.

What phase is cNP8 in?

cNP8 is in Phase 1 clinical development. A Phase 1 study has been completed, which enrolled 32 participants. The drug is investigational and has not been approved by regulatory authorities. It is being studied for the treatment of burns.

What clinical trials is cNP8 in?

cNP8 has one completed clinical trial, identified as NCT06223009, titled "Phase 1 Healthy Volunteer Burn Therapy Study." This was a randomized, double-blind, placebo-controlled trial conducted in the United States, enrolling 32 healthy volunteers aged 18 years and older.

Is cNP8 the same as any other drug?

No alternative names for cNP8 have been reported. The drug is identified solely as cNP8 in clinical trial records and is being developed by United Therapeutics Corporation for the treatment of burns.