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ABT-308

Phase 1

Asthma | Small molecule | Respiratory |AbbVie Inc.|Last Updated: Nov 21, 2017

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
RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment47
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00986037Assessment of the Safety of ABT-308 in Healthy Volunteers and Subjects With AsthmaPHASE1 COMPLETED 47Oct 1, 2009 -Nov 21, 2017 -
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Study Endpoints
Primary Endpoints
Safety and tolerability will be determined by evaluation of adverse events, vital sign monitoring, physical examination, electrocardiograms, lung function and laboratory assessments.
12 weeks after last dose
Secondary Endpoints
Pharmacokinetics will be determined by measuring serum concentration of ABT-308.
12 weeks after last dose
Immunogenicity will be determined by measuring serum concentrations of anti-ABT-308 antibodies.
12 weeks after last dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IV ABT-308 in asthmaticsEXPERIMENTALABT-308 single escalating doses in mild to moderate asthmatics
SC ABT-308 in asthmaticsEXPERIMENTALABT-308 multiple SQ doses in mild to moderate asthmatics
IV ABT-308 in healthy volunteersEXPERIMENTALABT-308 single escalating IV doses in healthy volunteers
Interventions
NameTypeDescription
ABT-308DRUGSingle IV doses
PlaceboDRUGSingle IV dose
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Healthy volunteers: 1. A condition of good health based upon the results of medical history, physical examination, vital signs, laboratory profile and ECG. 2. BMI 18 to 29, inclusive. * Mild asthma patients: 1. Diagnosis of well-controlled, mild to moderate asthma by G...

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