NCT06662123

Pharmacokinetic and Safety Study of Subcutaneous and Intravenous Anifrolumab Delivered in Healthy Adult Participants

A Randomized, Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Subcutaneously and Intravenously Delivered Anifrolumab in Healthy Chinese Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, Phase I, open-label, single-dose study to evaluate the PK, safety, and tolerability of anifrolumab administered to male and female healthy Chinese participants aged 18 to 55 years. Approximately 24 participants, who fulfill the eligibility criteria, will be administered anifrolumab via SC route or IV route, and participants will be randomized to the two arms in a 1:1 ratio.

Detailed description

The purpose of this study is to evaluate the PK, safety, and tolerability of a single dose of anifrolumab subcutaneously or intravenously administered to healthy Chinese participants aged 18 to 55 years. The primary study endpoints are PK standard endpoints. The secondary study endpoints are standard endpoints for safety assessment, including adverse events, serious adverse events, and clinical safety laboratory measurements. The participants must abstain from taking prescription or non-prescription drugs (including vitamins and dietary or herbal supplements) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before the start of study intervention until completion of the follow-up visit, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Anifrolumab	Participants will receive a single SC or IV dose of anifrolumab at day 1

Timeline

• Start date: 2024-10-21
• Primary completion: 2025-01-10
• Completion: 2025-01-10
• First posted: 2024-10-28
• Last updated: 2025-03-19

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study