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

NCT02601625 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-02-26

Study results available
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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

Conditions

  • Safety
  • Pharmacokinetics
  • Healthy 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

Sponsors & Collaborators

Principal Investigators

  • Ronald Goldwater, Dr. · PAREXEL Early Phase Clinical Unit, Baltimore, United States of America

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-16
Primary Completion
2016-05-25
Completion
2016-05-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02601625 on ClinicalTrials.gov