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GR2002

Phase 1

Asthma | Monoclonal antibody | Respiratory |Co-Diagnostics, Inc.|Last Updated: Aug 22, 2024

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_CONTROLLED
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05954611The Study of Single Dose Administration of GR2002 Injection in Chinese Health VolunteersPHASE1 COMPLETED 50Jun 16, 2023Jan 2, 2024Aug 22, 20241 China
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Study Endpoints
Primary Endpoints
Incidence of Adverse Events (AE)
85 days

Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing

Secondary Endpoints
Pharmacokinetics (PK) parameter: Time to reach peak concentration (Tmax)
85 days
Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)
85 days
Pharmacodynamics (PD): Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after GR2002 administration
85 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GR2002 injectionEXPERIMENTALGR2002 subcutaneous injection
placeboPLACEBO_COMPARATORplacebo subcutaneous injection
Interventions
NameTypeDescription
GR2002 injectionBIOLOGICALone single dose of GR2002 injection
PlaceboBIOLOGICALone single dose of placebo
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * 1\. Age of 18 to 55 years, inclusive, male or female 2. BMI between 19 kg/m2 and 26 kg/m2 (inclusive) 3. Healthy volunteers Exclusion Criteria: * 1\. History of chronic disease or serious disease 2. Subject with severe psychological or mental illness 3. Not enough washing-ou...

Countries:China
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