drugset / Trial / NCT05233085

A Safety Study of AZD4041 in Healthy Participants

NCT05233085

Phase 1 Completed 36 enrolled AstraZeneca Altasciences Company Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase 1, single-centre, randomized, double-blind, placebo-controlled, multiple ascending doses (MAD) study in healthy male and female adult participants. The study will include up to 48 participants (12 participants per cohort) who will be randomized 9:3 to active drug or placebo. Each cohort will receive AZD4041 or placebo in a MAD study. A sequential cohort MAD design will be employed to assure that higher doses are administered to healthy participants only after lower doses have demonstrated an acceptable safety profile. The total study duration will be up to 59 days (including Screening) per participant.

Timeline

Start
2021-12-17
Primary completion
2022-06-07
Completion
2022-06-07

Drugs

EvaluationDrugModalityDoseRoute
Subject AZD4041 Unknown

Indications