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

NCT04865393 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2024-04-15

No results posted yet for this study

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

DRUG

SPR206

SPR206 100 mg single-dose IV infused over 1 hour

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Spero Therapeutics

    lead INDUSTRY

Principal Investigators

  • David Melnick, MD · Spero Therapeutics Inc

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-08
Primary Completion
2021-12-01
Completion
2021-12-06

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04865393 on ClinicalTrials.gov