Recent Updates
Recently added Catalysts

Singletine

Phase 1

Healthy Subjects | Small molecule | Other |Co-Diagnostics, Inc.|Last Updated: Dec 7, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment75
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06160401Evaluation of Safety, Tolerability, PK/PD, and Metabolism of Single-Dose Singletine(DC407) in AdultsPHASE1 COMPLETED 75 — — Aug 18, 2020Jan 30, 2021Dec 7, 20231 China
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
First dose of study drug up to 31 days after last dose of study drug

Assessment by adverse event monitoring CTCAE 5.0

Secondary Endpoints
Area Under the Curve（AUC） From Time Zero to Last Quantifiable Concentration
Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72 hours following single dose administration;
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72 hours following single dose administration;
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Singletine（DC407） ascending doseEXPERIMENTALSingle ascending dose
Singletine（DC407）food influence groupEXPERIMENTALFood influence group
Singletine placebo comparator(Single ascending dose)PLACEBO_COMPARATORSingle ascending dose
Singletine placebo comparator(food influence group)PLACEBO_COMPARATORFood influence group
Interventions
NameTypeDescription
SingletineDRUGSingletine orally administered
PlaceboDRUGPlacebo orally administered
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Age 18-45 years old (including both endpoints), healthy males or females; * Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) between 19-28 kg/m2 (including both endpoints); * No significant abnormal clinical symptoms, normal physical examination, vital signs, 12...

Countries:China
Unlock Eligibility Criteria