NCT04865393

Phase 1 Study of PK and Safety of SPR206 in Subjects With Various Degrees Of Renal Function

A Phase 1, Open-label Study to Assess the Safety and Pharmacokinetics of SPR206 Following a Single IV Dose of SPR206 in Subjects With Varying Degrees of Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Spero Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Evaluation of the pharmacokinetics (PK) of SPR206 in subjects with normal renal function, subjects with various degrees of renal insufficiency, and subjects with end-stage renal disease (ESRD) receiving hemodialysis (HD) therapy.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	SPR206	SPR206 100 mg single-dose IV infused over 1 hour

Timeline

• Start date: 2021-06-08
• Primary completion: 2021-12-01
• Completion: 2021-12-06
• First posted: 2021-04-29
• Last updated: 2024-04-15

Locations

2 sites across 1 country: New Zealand