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ABBV-CLS-7262

Phase 1

Healthy | Small molecule | Other |AbbVie Inc.|Last Updated: Jun 26, 2023

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05763459A Phase 1 Study of ABBV-CLS-7262, Rosuvastatin, and Digoxin in Healthy SubjectsPHASE1 COMPLETED 12Mar 24, 2023Jun 2, 2023Jun 26, 20231 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetics of Rosuvastatin
Two Weeks

Area under the Curve (AUC)

Pharmacokinetics of Digoxin
Two Weeks

Area under the Curve (AUC)

Secondary Endpoints
Safety and Tolerability
Two Weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABBV-CLS-7262EXPERIMENTALABBV-CLS-7262 + Digoxin + Rosuvastatin
Interventions
NameTypeDescription
ABBV-CLS-7262DRUGDrug: ABBV-CLS-7262 Drug: Digoxin Drug: Rosuvastatin
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Adult volunteers in general good health * Must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures * Individuals between 18 and ...

Countries:United States
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