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dalazatide

Phase 1

Healthy | Small molecule | Other |TuHURA Biosciences, Inc.|Last Updated: May 18, 2015

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment32

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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Frequently asked questions about dalazatide

What is dalazatide used for?

Dalazatide is an investigational small molecule being studied for plaque psoriasis and in healthy volunteers. It is developed by TuHURA Biosciences, Inc. (HURA). Dalazatide is in Phase 1 clinical development and is not approved by the FDA.

What does dalazatide target?

Dalazatide is a small molecule that targets the Kv1.3 potassium channel on effector memory T cells. By blocking this channel, it may modulate the immune response involved in plaque psoriasis. This mechanism is being evaluated in early-stage clinical trials.

Who makes dalazatide?

Dalazatide is being developed by TuHURA Biosciences, Inc., a biopharmaceutical company listed on the stock exchange under the ticker HURA. The company is conducting Phase 1 clinical trials to evaluate the safety and pharmacodynamics of dalazatide.

What phase is dalazatide in?

Dalazatide is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, one in patients with plaque psoriasis and one in healthy volunteers.

What clinical trials is dalazatide in?

Dalazatide has been studied in two completed Phase 1 trials. NCT02435342 evaluated a 4-week course in patients with active plaque psoriasis in Canada. NCT02446340 was a multiple ascending dose study in healthy volunteers in the United States. Both trials are completed.

Is dalazatide the same as ShK-186?

Yes, dalazatide is also known as ShK-186. Clinical trial records refer to the drug as ShK-186 (Dalazatide). Both names refer to the same investigational small molecule being developed by TuHURA Biosciences for plaque psoriasis.