CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
Anifrolumab SC injection (300mg) +5 moredrug
Likely dose
Anifrolumab SC injection (300mg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02601625
NCT02601625Phase 1Completed
CompareCT.gov

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.

AstraZeneca·interventional·Posted Nov 10, 2015·Updated Feb 26, 2019

In Brief

A Phase 1 clinical trial evaluating Anifrolumab SC injection (300mg), Anifrolumab IV infusion (300mg), and 4 other interventions for Safety and 2 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSafety, Pharmacokinetics, Healthy Subjects
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 10, 2015
Enrollment StartNov 16, 2015
Primary CompletionMay 25, 2016
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 10.6 years ago

Interventions

Anifrolumab SC injection (300mg)drug

300 mg of anifrolumab delivered as 2 separate 1 mL SC injections administered serially on Day 1

Anifrolumab IV infusion (300mg)drug

300 mg of anifrolumab delivered as an IV infusion over 30 minutes on Day 1

Anifrolumab SC infusion (600mg)drug

600 mg of anifrolumab delivered as 4 mL SC by infusion pump on Day 1

Anifrolumab placebo SC injection (300mg)drug

300mg of placebo delivered as 2 separate 1 mL SC injections administered serially on Day 1

Anifrolumab placebo IV infusion (300mg)drug

600mg of placebo delivered as an IV infusion over 30 minutes on Day 1

Anifrolumab placebo SC infusion (600mg)drug

600 mg of placebo delivered as 4 mL SC by infusion pump on Day 1