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dalazatide

Phase 1

Plaque Psoriasis | Small molecule | Dermatology |TuHURA Biosciences, Inc.|Trials Updated: May 6, 2015

dalazatide development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since May 2015

dalazatide target and mechanism

Target class-Tide (Peptide)
ModalitySmall molecule

Also known as ShK-186

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

dalazatide clinical trials

dalazatide · 1 trial · 1 indication

Phase 1 1
NCT02435342A 4 Week Study of the Safety, Tolerability, and Pharmacodynamics of ShK-186 (Dalazatide) in Active Plaque PsoriasisPlaque Psoriasis
COMPLETED24 Analytics
PHASE1COMPLETED
A 4 Week Study of the Safety, Tolerability, and Pharmacodynamics of ShK-186 (Dalazatide) in Active Plaque Psoriasis
Plaque PsoriasisUnlock 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.

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:Canada
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Frequently asked questions about dalazatide

What is dalazatide used for?

Dalazatide is an investigational small molecule being developed for the treatment of plaque psoriasis, a chronic inflammatory skin condition. It has been studied in a Phase 1 clinical trial in adults with active plaque psoriasis. Dalazatide is not yet approved for any indication and remains in clinical development.

Who is developing dalazatide?

Dalazatide is being developed by TuHURA Biosciences, Inc., a biopharmaceutical company that trades under the ticker symbol HURA. The company is responsible for the clinical development of dalazatide in plaque psoriasis.

What phase is dalazatide in?

Dalazatide is in Phase 1 clinical development. It has completed one Phase 1 trial in plaque psoriasis. There are currently no active trials of dalazatide. The drug is investigational and has not been approved by the FDA or any regulatory agency.

What clinical trials is dalazatide in?

Dalazatide has been evaluated in a single completed Phase 1 trial, NCT02435342, titled "A 4 Week Study of the Safety, Tolerability, and Pharmacodynamics of ShK-186 (Dalazatide) in Active Plaque Psoriasis." The trial enrolled 24 participants in Canada and was randomized, double-blind, and controlled.

Is dalazatide the same as ShK-186?

Yes, dalazatide is also known as ShK-186. The Phase 1 trial NCT02435342 refers to the drug as ShK-186 (Dalazatide), confirming that both names identify the same investigational compound being developed for plaque psoriasis.