NCT02601625

A Study to Assess the Pharmacokinetics and Safety of Single Doses of Anifrolumab in Healthy Subjects

A Randomized, Phase 1, Placebo-controlled, Double-blind, Single-dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Subcutaneously and Intravenously Delivered Anifrolumab in Healthy Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Pharmacokinetics and Safety of anifrolumab following Single-Dose administration to healthy subjects

Detailed description

This is a Phase I placebo-controlled study to assess the pharmacokinetics, safety and tolerability of 2 doses of anifrolumab via the subcutaneous (SC) route of administration and 1 dose of anifrolumab via intravenous (IV) route in healthy subjects

Conditions

• Safety
• Pharmacokinetics
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Anifrolumab SC injection (300mg)	300 mg of anifrolumab delivered as 2 separate 1 mL SC injections administered serially on Day 1
DRUG	Anifrolumab IV infusion (300mg)	300 mg of anifrolumab delivered as an IV infusion over 30 minutes on Day 1
DRUG	Anifrolumab SC infusion (600mg)	600 mg of anifrolumab delivered as 4 mL SC by infusion pump on Day 1
DRUG	Anifrolumab placebo SC injection (300mg)	300mg of placebo delivered as 2 separate 1 mL SC injections administered serially on Day 1
DRUG	Anifrolumab placebo IV infusion (300mg)	600mg of placebo delivered as an IV infusion over 30 minutes on Day 1
DRUG	Anifrolumab placebo SC infusion (600mg)	600 mg of placebo delivered as 4 mL SC by infusion pump on Day 1

Timeline

• Start date: 2015-11-16
• Primary completion: 2016-05-25
• Completion: 2016-05-25
• First posted: 2015-11-10
• Last updated: 2019-02-26
• Results posted: 2019-02-26

Locations

1 site across 1 country: United States