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SHR-1819

Phase 1

Asthma | Small molecule | Respiratory |Co-Diagnostics, Inc.|Last Updated: Nov 29, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04772365A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study in Healthy SubjectsPHASE1 COMPLETED 52Mar 1, 2021Dec 10, 2021Nov 29, 20221 China
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Study Endpoints
Primary Endpoints
Adverse events
Start of Treatment to end of study(about 13 weeks)

Incidence and severity of adverse events

Secondary Endpoints
Pharmacokinetics-AUC0-last
Start of Treatment to end of study (about 13 weeks)
Pharmacokinetics-AUC0-inf
Start of Treatment to end of study (approximately 13 weeks)
Pharmacokinetics-Tmax
Up to 13 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment group AEXPERIMENTAL -
Treatment group BPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
SHR-1819DRUGSHR-1819 will be subcutaneously administered with different dose levels;
PlaceboDRUGPlacebo will be subcutaneously administered with different dose levels;
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent. 2. Be able to comply with all the requirements and able to complete the study. 3. Male or female aged between 18 years and 55...

Countries:China
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