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

Sponsor
AstraZeneca
Study ID
NCT07688980
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Anifrolumab: SC formulation via AI — COMBINATION_PRODUCT
    Anifrolumab will be administered subcutaneously via an AI.
  • Anifrolumab: IV formulation — COMBINATION_PRODUCT
    Anifrolumab will be administered intravenously.
  • Anifrolumab: SC formulation via aPFS — COMBINATION_PRODUCT
    Anifrolumab will be administered subcutaneously via an aPFS.

Study Details

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).

Key Dates

First listed
Jul 7, 2026
Start date
Oct 30, 2026
Status verified
Jun 2026
Primary completion
Apr 13, 2029
Completion
Jun 14, 2030

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: SC
    Participants will receive SC anifrolumab administered via AI.
  • Experimental: Part A: IV
    Participants will receive IV anifrolumab infusion.
  • Experimental: Part B
    Participants will receive SC anifrolumab administered via aPFS.

Primary Outcome Measure

Anifrolumab serum concentrations through Week 4 [ Time Frame: Up to Week 4 ]

Central Contacts

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