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SPR206

Phase 1

Renal Impairment | Small molecule | Nephrology |Spero Therapeutics, Inc.|Trials Updated: Apr 15, 2024

SPR206 development status

Highest phase Phase 1
Registered trials 3 across 1 sponsor since Jan 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

SPR206 clinical trials

SPR206 · 1 trial · 1 indication

Phase 1 1
NCT04865393Phase 1 Study of PK and Safety of SPR206 in Subjects With Various Degrees Of Renal FunctionRenal Impairment
COMPLETED37 Analytics
PHASE1COMPLETED
Phase 1 Study of PK and Safety of SPR206 in Subjects With Various Degrees Of Renal Function
Renal ImpairmentUnlock trial analytics

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 to 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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Frequently asked questions about SPR206

What is SPR206?

SPR206 is an investigational small molecule developed by Spero Therapeutics, Inc. (ticker SPRO). It has been studied in a Phase 1 clinical trial in subjects with varying degrees of renal function, including renal impairment. It is not an approved medicine and remains in clinical development.

What is SPR206 used for?

SPR206 has been evaluated for use in renal impairment, with a Phase 1 study examining its pharmacokinetics and safety in subjects with various degrees of renal function. The program is at the Phase 1 stage, so SPR206 is investigational and has no approved indication.

Who makes SPR206?

SPR206 is developed by Spero Therapeutics, Inc., which trades under the ticker SPRO. The company sponsored the Phase 1 study of SPR206 in subjects with various degrees of renal function.

What phase is SPR206 in?

SPR206 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. SPR206 is investigational and has not been approved by the FDA for any indication.

What clinical trials is SPR206 in?

SPR206 has been studied in one completed Phase 1 trial, NCT04865393, titled a Phase 1 Study of PK and Safety of SPR206 in Subjects With Various Degrees Of Renal Function. It enrolled 37 participants in New Zealand and was an uncontrolled study without randomization or blinding.