NCT03235375

A Study to Evaluate Pharmacokinetics, Safety and Tolerability of MEDI0382 in Renal Impairment Subjects

A Phase 1, Open-Label, Single Dose, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of MEDI0382 in Subjects With Renal Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A phase 1 open-label, single-dose study to evaluate the pharmacokinetics (PK), safety, tolerability and immunogenicity of MEDI0382 in subjects with renal impairment.

Detailed description

This is an open-label, single-dose, parallel group study to evaluate the PK, safety, tolerability, and immunogenicity of MEDI0382 in subjects with renal impairment. Enrollment of approximately 40 subjects across multiple sites is planned. Subjects will be divided into 4 groups based on renal function.

Conditions

• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	MEDI0382	MEDI0382 administered subcutaneously

Timeline

• Start date: 2017-10-27
• Primary completion: 2018-04-24
• Completion: 2018-04-24
• First posted: 2017-08-01
• Last updated: 2018-05-01

Locations

4 sites across 2 countries: Germany, New Zealand