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Study to Characterise Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Anifrolumab Administered Subcutaneously (SC) or Intravenously (IV)

NCT07688980 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-07-07

No results posted yet for this study

Summary

The purpose of this study is to assess the PK, PD, and safety of anifrolumab as SC administration or IV infusion in adult participants with systemic lupus erythematosus (SLE).

Conditions

Interventions

COMBINATION_PRODUCT

Anifrolumab: SC formulation via AI

Anifrolumab will be administered subcutaneously via an AI.

COMBINATION_PRODUCT

Anifrolumab: IV formulation

Anifrolumab will be administered intravenously.

COMBINATION_PRODUCT

Anifrolumab: SC formulation via aPFS

Anifrolumab will be administered subcutaneously via an aPFS.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-30
Primary Completion
2029-04-13
Completion
2030-06-14
FDA Drug
Yes

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Entities

Diseases
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 NCT07688980 on ClinicalTrials.gov