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SPR206

Phase 1

Renal Impairment | Small molecule | Nephrology |Spero Therapeutics, Inc.|Last Updated: Apr 15, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment37
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04865393Phase 1 Study of PK and Safety of SPR206 in Subjects With Various Degrees Of Renal FunctionPHASE1 COMPLETED 37 — — Jun 8, 2021Dec 6, 2021Apr 15, 20242 New Zealand
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Study Endpoints
Primary Endpoints
Time to the maximum plasma concentration (Tmax)
36 hours after start of study drug IV infusion
Maximum plasma concentration (Cmax)
36 hours after start of study drug IV infusion
Area under the concentration-time curve from time 0 to last measurable timepoint (AUC0-t)
36 hours after start of study drug IV infusion
Area under the concentration-time curve from time 0 to infinity (AUC0-∞)
36 hours after start of study drug IV infusion
Secondary Endpoints
Area under the concentration-time curve from time 0 to 8 hours (AUC0-8)
8 hours after start of study drug IV infusion
Terminal Elimination Rate Constant (kel)
36 hours after start of study drug IV infusion
Terminal half-life (t1/2)
36 hours after start of study drug IV infusion
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
SPR206EXPERIMENTALSPR206 100mg single-dose IV infused over 1 hour
Interventions
NameTypeDescription
SPR206DRUGSPR206 100 mg single-dose IV infused over 1 hour
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites2

Key Inclusion Criteria: * BMI ≥ 18.5 and ≤ 39.9 (kg/m2) and weight between 50.0 and 130.0 kg (inclusive) * Medically healthy without clinically significant abnormalities (Healthy Volunteers) or medically stable without clinically significant acute or chronic illness (Subjects with varying degrees o...

Countries:New Zealand
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