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RG002C0106

Phase 1

Renal Impairments | Small molecule | Nephrology |Co-Diagnostics, Inc.|Last Updated: Mar 3, 2026

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07445906A Study of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal ImpairmentPHASE1 NOT YET_RECRUITING 24 — — Mar 15, 2026Dec 1, 2026Mar 3, 2026 - —
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Study Endpoints
Primary Endpoints
Calculate the pharmacokinetic (PK) parameters:Cmax
From enrollment to the end of treatment at 4 days
Calculate the pharmacokinetic (PK) parameters:Tmax
From enrollment to the end of treatment at 4 days
Calculate the pharmacokinetic (PK) parameters:AUC0-12h , AUC0-24h , AUC0-t, AUC0-∞
From enrollment to the end of treatment at 4 days
Calculate the pharmacokinetic (PK) parameters:t½
From enrollment to the end of treatment at 4 days
Calculate the pharmacokinetic (PK) parameters:Vd/F
From enrollment to the end of treatment at 4 days
Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug.
up to 169 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
RG002C0106 InjectionEXPERIMENTAL -
Interventions
NameTypeDescription
RG002C0106DRUGSubcutaneous (SC) single dose 200mg
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: 1. Have been fully informed about the study, volunteered to participate, and provided written informed consent. 2. Male or female participants aged 18-60 years (inclusive) at screening. 3. Body mass index (BMI) of 19.0-32.0 kg/m² (inclusive) at screening; body weight ≥ 50 kg for...

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