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ASLAN004

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment44
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03721263Study of ASLAN004 in Healthy SubjectsPHASE1 COMPLETED 44 — — Oct 15, 2018Jun 20, 2019Aug 5, 20201 Singapore
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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 — 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
CompanyTickerTrialsLead PhaseDrugs
DBV Technologies SA Sponsored ADRDBVT1PHASE3DBV712
Nasus PharmaNSRX1PHASE1FMXIN002 single dose, Epinephrine autoinjector single dose
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