AM1476/Placebo Study in Healthy Subjects
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Safety
- Tolerability
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: SAD part: sentinel dosing for 6 groups divided into 2 cohorts. MAD part: 3 groups Each group consists of 8 subjects, 6 will receive AM1476 and 2 will receive placebo.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 60 years
- Gender
- Both males and females
Description
Double-blind, randomised, placebo-controlled, single- and multiple-oral dose study conducted in 2 parts, for evaluation of AM1476. Part A will comprise a single-ascending dose, sequential-group design incorporating a single-group, 2-period crossover arm incorporating a food-effect evaluation. Overal...
Double-blind, randomised, placebo-controlled, single- and multiple-oral dose study conducted in 2 parts, for evaluation of AM1476. Part A will comprise a single-ascending dose, sequential-group design incorporating a single-group, 2-period crossover arm incorporating a food-effect evaluation. Overall, 48 subjects will be studied in 6 groups, with each group consisting of 8 subjects. Part B will comprise a multiple-ascending dose, sequential-group design. Overall, 24 subjects will be studied in 3 groups, with each group consisting of 8 subjects. The primary objective of the study is to determine the safety and tolerability of single- and multiple-oral doses of AM1476 in healthy subjects.
Tracking Information
- NCT #
- NCT04691115
- Collaborators
- Covance
- Investigators
- Principal Investigator: Ashley Brooks, MD, MBChB Covance