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Vasostrict Injectable Product

Phase 1

Healthy Volunteer Safety Study | Small molecule | Other |BrainsWay Ltd.|Last Updated: May 19, 2021

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Clinical trial landscape

Vasostrict Injectable Product · 1 trial · 1 indication

Phase 1 1
NCT04093050Safety and Pharmacokinetics of Vasopressin in Healthy VolunteersHealthy Volunteer Safety Study
COMPLETED41 Analytics
PHASE1COMPLETED
Safety and Pharmacokinetics of Vasopressin in Healthy Volunteers
Healthy Volunteer Safety Study
NCT0409305041
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Study Endpoints

Primary Endpoints

Plasma Clearance of vasopressin following IV administration in participants with TT genotype versus AA/AT genotype
15 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TT GenotypeEXPERIMENTAL -
AA/AT GenotypeEXPERIMENTAL -

Interventions

NameTypeDescription
Vasostrict Injectable ProductDRUGVasostrict® (vasopressin injection, USP)
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: 1. Signed the informed consent form (ICF) approved by an institutional review board (IRB). 2. Determined to have genotype TT, AA, or AT. 3. Weighs at least 50 kg and not more than 100 kg. 4. If female, must be surgically sterile for at least 6 months prior to screening, post-men...

Countries:United States
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