Conditions: Healthy Volunteers
Keywords: healthy volunteers
Allocation: RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 49
Healthy volunteers: yes

Brief summary:
The primary objective is to evaluate the safety, tolerability, and immunogenicity of multiple-dose administration of tezepelumab in healthy adults.

Detailed description:
This study will follow a randomized, multiple-dose, double-blind, placebo-controlled, sequential dose-escalation study design. The study will consist of five subcutaneous (SC) cohorts and one intravenous (IV) cohort. Each dose cohort is planned to enroll 8 participants, randomized such that 6 participants will receive tezepelumab and 2 will receive placebo (3:1 ratio).

Arms:
arm 1: Tezepelumab will be administered subcutaneously (SC) at doses from 35 mg once every 28 days (Q28D) (cohort 1) up to 210 mg once every 7 days (Q7D) (cohort 5) and an intravenous (IV) dose cohort of 700 mg Q28D (cohort 6). arm 2: Two participants in each cohort (cohorts 1 to 6) will receive matching placebo administered subcutaneously (cohorts 1-5) or intravenously (cohort 6), matching the treatment regiment of tezepelumab.

Interventions: intervention 1: Placebo intervention 2: Tezepelumab
Intervention descriptions: intervention 1: Administered by subcutaneous or intravenous injection. intervention 2: Administered by subcutaneous or intravenous injection

Protocol document: