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

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 16, 2015

Primary Completion Date

May 25, 2016

Study Completion Date

May 25, 2016

Conditions
SafetyPharmacokineticsHealthy Subjects
Interventions
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

Trial Locations (1)

21225

Research Site, Baltimore

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY