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dalazatide

Phase 1

Plaque Psoriasis | Small molecule | Dermatology |TuHURA Biosciences, Inc.|Last Updated: May 18, 2015

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical trial landscape

dalazatide · 2 trials · 2 indications

Phase 1 2
NCT02435342A 4 Week Study of the Safety, Tolerability, and Pharmacodynamics of ShK-186 (Dalazatide) in Active Plaque PsoriasisPlaque Psoriasis
COMPLETED24 Analytics
NCT02446340Multiple Ascending Dose Safety Study of ShK-186 (Dalazatide) in Healthy VolunteersHealthy
COMPLETED32 Analytics
PHASE1COMPLETED
A 4 Week Study of the Safety, Tolerability, and Pharmacodynamics of ShK-186 (Dalazatide) in Active Plaque Psoriasis
Plaque PsoriasisUnlock trial analytics
PHASE1COMPLETED
Multiple Ascending Dose Safety Study of ShK-186 (Dalazatide) in Healthy Volunteers
HealthyUnlock trial analytics
Study Endpoints
Primary Endpoints
Subjects with adverse events
From randomization through Day 57 (12 timepoints)
Secondary Endpoints
Target lesion assessment
From randomization to Day 57 (4 timepoints)
Psoriasis Area Severity Index (PASI) score
From randomization to Day 57 (4 timepoints)
Patient and Investigator Global Assessment of Psoriasis
From randomization to Day 57 (4 timepoints)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
Treatment Arms
ArmTypeDescription
30ug dalazatideEXPERIMENTAL12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks.
60ug dalazatideEXPERIMENTAL12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks.
dalazatide 5ugEXPERIMENTAL8 subjects, 6 given active agent and 2 given placebo
dalazatide 15ugEXPERIMENTAL8 subjects, 6 given active agent and 2 given placebo
dalazatide 30ugEXPERIMENTAL8 subjects, 6 given active agent and 2 given placebo
dalazatide 60ugEXPERIMENTAL8 subjects, 6 given active agent and 2 given placebo
Interventions
NameTypeDescription
dalazatideDRUGSubcutaneous injection twice per week for a total of 9 doses, followed by four weeks of follow-up.
placeboDRUGplacebo, Subcutaneous injection twice per week for a total of 9 doses
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Eligibility Criteria
Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Adult male and female subjects, ages 18-65; 2. Active plaque psoriasis with ≥3% BSA involved; 3. An adequate number of vulgar psoriatic plaques of at least 2 cm X 2 cm with Target Lesion Investigator Global Assessment scores \>3, that are not located on the face, scalp, groin...

Countries:CanadaUnited States
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