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HDDO-1756

Phase 1

Hyperlipidemias | Small molecule | Metabolic |Co-Diagnostics, Inc.|Last Updated: Feb 17, 2021

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04755894HDDO-1756 Bio Equivalence StudyPHASE1 COMPLETED 56Jun 12, 2020Jul 27, 2020Feb 17, 20211 South Korea
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Study Endpoints
Primary Endpoints
pharmacokinetic evaluation variables
0~96 hours

Cmax

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
group AEXPERIMENTAL -
group BACTIVE_COMPARATOR -
Interventions
NameTypeDescription
HDDO-1756DRUGsingle dose
HDDO-17561/HDDO-17562DRUGsingle dose
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Eligibility Criteria
Age Range19 Years — N/A
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy adult volunteers aged 19 or older during screening 2. A person who weighs more than 50.0 kg and has a BMI of 18.0 kg/m2 or less and 30.0 kg/m2 or less. ☞ BMI (kg/m2) = Weight (kg) / {Long (m)}2 3. A person who has no chronic disease or medical treatment and has no...

Countries:South Korea
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