NCT04154670

Study Assessing PK and Safety of MGTA-145 in Subjects With Normal Estimated GFR and Varying Degrees of Renal Impairment

An Open Label, Single Arm, Single Dose Study to Evaluate the Pharmacokinetics and Safety and Tolerability of MGTA 145 in Subjects With Normal Estimated GFR and Varying Degrees of Renal Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Ensoma · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

This study is being conducted in healthy subjects and in subjects with a mild or moderate decrease in GFR (subjects with renal impairment).

Detailed description

To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MGTA-145 in Subjects With Normal Estimated GFR and Varying Degrees of Renal Impairment

Conditions

• Healthy
• Renal Insufficiency

Interventions

Type	Name	Description
BIOLOGICAL	MGTA-145	MGTA-145 will be given intravenously

Timeline

• Start date: 2019-11-07
• Primary completion: 2020-03-24
• Completion: 2020-03-24
• First posted: 2019-11-06
• Last updated: 2024-01-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study