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ASLAN004

Phase 1

Allergic Disorder | Monoclonal antibody | Other |IQVIA Holdings, Inc.|Last Updated: Aug 5, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

Clinical trial landscape

ASLAN004 · 1 trial · 1 indication

Phase 1 1
NCT03721263Study of ASLAN004 in Healthy SubjectsAllergic Disorder
COMPLETED44 Analytics
PHASE1COMPLETED
Study of ASLAN004 in Healthy Subjects
Allergic Disorder
NCT0372126344
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Study Endpoints

Primary Endpoints

Evaluation of product safety by assessing the incidence of treatment-emergent adverse events following single ascending dose administration in healthy volunteers at Day 1 until study completion
85 days

To evaluate the safety of the product by assessing its impact on the healthy volunteer following single dose administration through review of adverse event listings

Secondary Endpoints

PK parameters: Area under the curve (AUC) from time zero to the time of the last quantifiable concentration [AUC(0-last)]
Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months
PK parameters: Estimate of volume of distribution at steady state (Vss)
Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months
PK parameters: Subcutaneous bioavailability (F)
Predose,1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 72 hour, 168 hour, 240 hour and up to 3 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ASLAN004 Single Ascending DoseEXPERIMENTALUp to 10 dose levels are planned. ASLAN004 by IV route: 0.1 mg/kg (Cohort 1), 0.3 mg/kg (Cohort 2), 1 mg/kg (Cohort 3), 3 mg/kg (Cohort 4) and 10 mg/kg (Cohort 5), 20 mg/kg (Cohort 6 \[optional\]). ASLAN004 SC route: 75 mg (Cohort 7), 150 mg (Cohort 8), 300 mg (Cohort 9), and 600 mg (Cohort 10 \[optional\]).

Interventions

NameTypeDescription
ASLAN004BIOLOGICALSingle Dose
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Eligibility Criteria

Age Range21 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Must be able to sign informed consent form 2. Male and female subjects who are of legal age 3. Healthy, BMI 18.5 to 30 kg/m2 4. Normal or clinically acceptable clinical laboratory value and ECG results Exclusion Criteria: 1. History of hypersensitivity reaction 2. Have food...

Countries:Singapore
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Competitive Landscape -Allergic Disorders 3 trials (matched to "Allergic Disorder")

CompanyTickerTrialsLead PhaseDrugs
DBV Technologies SA Sponsored ADRDBVT1PHASE3DBV712
Nasus Pharma Ltd.NSRX1PHASE1FMXIN002 single dose, Epinephrine autoinjector single dose
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Frequently asked questions about ASLAN004

What is ASLAN004 used for?

ASLAN004 is an investigational monoclonal antibody being studied for the treatment of allergic disorders. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in clinical trials to assess its safety and potential efficacy in this patient population.

What does ASLAN004 target?

ASLAN004 is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. The drug is being investigated for its potential role in treating allergic disorders, though the exact mechanism of action remains unspecified in the current clinical trial data.

Who is developing ASLAN004?

ASLAN004 is being developed by IQVIA Holdings, Inc., a company publicly traded under the ticker symbol IQV. The drug is currently in Phase 1 clinical development for the treatment of allergic disorders, with the company conducting trials to evaluate its safety and efficacy.

What phase is ASLAN004 in?

ASLAN004 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval for commercial use. The Phase 1 trial has been completed, and the drug remains under investigation for the treatment of allergic disorders.

What clinical trials is ASLAN004 in?

ASLAN004 has one completed Phase 1 clinical trial registered under NCT03721263, titled 'Study of ASLAN004 in Healthy Subjects.' This trial enrolled 44 participants in Singapore and evaluated the drug in healthy volunteers aged 21 years and older. The study was not randomized, double-blind, or controlled.

Is ASLAN004 the same as other drugs?

ASLAN004 is not known to have any alternative names or be the same as other drugs based on the available information. It is a distinct investigational monoclonal antibody being developed by IQVIA Holdings, Inc. for the treatment of allergic disorders.