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

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Healthy Volunteers

Interventions: Anifrolumab

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Wuhan, China