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CAL-263

Phase 1

Allergic Rhinitis | Small molecule | Respiratory |Gilead Sciences, Inc.|Last Updated: May 5, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

CAL-263 · 1 trial · 1 indication

Phase 1 1
NCT01066611Study to Investigate Effects of CAL-263 in Subjects With Allergic Rhinitis Exposed to Allergen in an Environmental ChamberAllergic Rhinitis
COMPLETED48 Analytics
PHASE1COMPLETED
Study to Investigate Effects of CAL-263 in Subjects With Allergic Rhinitis Exposed to Allergen in an Environmental Chamber
Allergic RhinitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate the safety of CAL-263 in allergic rhinitis subjects
46 days

Secondary Endpoints

Determine the efficacy of CAL-263 on total nasal symptom scores following an allergen challenge in allergic rhinitis subjects
7 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORCAL-263
2PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
CAL-263DRUGCAL-263 10 mg or placebo once daily for 7 days
PlaceboDRUGCAL-263 10 mg or placebo once daily for 7 days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Age \>18 and \<55 years 2. Has a history of seasonal allergic rhinitis for at least 2 years 3. Has sensitivity to grass pollen demonstrated by a positive response to skin prick testing 4. Has a positive Radio Allergen Sorbent Test (class 2 or greater) for grass pollen during ...

Countries:Austria
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Competitive Landscape -Allergic Rhinitis 4 trials

Frequently asked questions about CAL-263

What is CAL-263 used for?

CAL-263 is an investigational small molecule being studied for the treatment of allergic rhinitis. It has been evaluated in a Phase 1 clinical trial involving subjects with allergic rhinitis who were exposed to allergen in an environmental chamber. The drug is not approved and remains in clinical development.

Who is developing CAL-263?

CAL-263 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company conducted a Phase 1 clinical trial of CAL-263 in subjects with allergic rhinitis.

What phase is CAL-263 in?

CAL-263 is in Phase 1 clinical development. A Phase 1 trial of CAL-263 has been completed. The drug is investigational and has not been approved for any use.

What clinical trials has CAL-263 been in?

CAL-263 has been studied in one completed Phase 1 clinical trial, identified as NCT01066611. This trial investigated the effects of CAL-263 in subjects with allergic rhinitis exposed to allergen in an environmental chamber. The study enrolled 48 participants and was conducted in Austria.

Was the CAL-263 clinical trial randomized and controlled?

Yes, the Phase 1 clinical trial of CAL-263 was a randomized, double-blind, placebo-controlled study. The trial enrolled 48 participants aged 18 years and older with allergic rhinitis. The study was conducted in Austria and has been completed.