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

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Anifrolumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT06662123

D3465C00004

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Able to complete the follow-up visit as required by the protocol.
Participant must be 18 to 55 years of age (both inclusive), at the time of signature of the ICF.
A body mass index of ≥ 18.5 to ≤ 26.0 kg/m2 and body weight of at least 45 kg for females and 50 kg for males at screening.
Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Exclusion criteria

History of malignancy with some exceptions
History of alcohol or drug abuse within the past 2 years.
Any significant disease, disorder, or finding that may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data.