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D-0502

Phase 1

Healthy Female Volunteer | Small molecule | Other |Co-Diagnostics, Inc.|Last Updated: Aug 8, 2022

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
RandomizedCONTROLLED
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05226338Evaluation of Relative Bioavailability of D-0502 Tablet in Healthy Female SubjectsPHASE1 COMPLETED 18Oct 27, 2021May 11, 2022Aug 8, 20221 United States
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Study Endpoints
Primary Endpoints
Access the oral bioavailability of D-0502 100mg and 200mg tablets
Single Dose, 3 period, 3 treatment study separated by 14 day washout periods to evaluate safety and bioavailability. Overall time in study is approximately 42 days.

Access the oral bioavailability of D-0502 100mg and 200mg tablets relative to D-0502 50mg tablet formulation

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Sequence 1EXPERIMENTAL3 period, 3 dose level
Sequence 2EXPERIMENTAL3 period, 3 dose level
Sequence 3EXPERIMENTAL3 period, 3 dose level
Sequence 4EXPERIMENTAL3 period, 3 dose level
Sequence 5EXPERIMENTAL3 period, 3 dose level
Sequence 6EXPERIMENTAL3 period, 3 dose level
Interventions
NameTypeDescription
D-0502DRUGFormulation 1 Formulation 2 Formulation 3
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Eligibility Criteria
Age Range18 Years — 55 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy female subjects between the ages of 18-55 * Required evaluation by Investigator for screening and enrollment * Agreement and compliance with the study and follow-up procedures Exclusion Criteria: * Significant medical history or current comorbidly determined by the I...

Countries:United States
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