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A Phase 1 Randomized, Single-blind, Placebo-controlled, First-in-Human and Sequential Group Study to Assess Safety, Tolerability, and Pharmacokinetics of AZD0186 Following Single Ascending Doses Via Oral Administration
This study will assess the safety, tolerability, and pharmacokinetics of AZD0186 following single ascending doses (SAD) via oral administration in healthy adult participants.
This is a Phase 1, First-in-Human (FIH), randomized, single-blind, sponsor-open, placebo-controlled, SAD sequential group design study. This study consists of four parts: Part 1, Part 2, Part 3, and Part 4. The study will comprise of the following: Part 1, Part 2, Part 3, and Part 4: * A Screening Period of maximum 28 days. * A Treatment Period during which subjects will be resident at the Clinical Unit from 2 days before IMP (Investigational Medicinal Product) administration (Day -2) until at least 48 hours after IMP administration; discharged on Day 3. Part 4: • A second Treatment Period during which subjects will be resident at the Clinical Unit from the day of the Follow-up Visit (Day 7 ±1 days after the last IMP dose) until at least 48 hours after the second IMP administration; discharged on Day 10. Part 1, Part 2, Part 3, and Part 4: • A Follow-up Visit after 7 (Part 1, Part 2, and Part 3) or 14 (Part 4) ±1 day after the last IMP dose.
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
Yes
Research Site
Glendale, California, United States
Start Date
December 20, 2022
Primary Completion Date
May 10, 2023
Completion Date
May 10, 2023
Last Updated
December 13, 2024
31
ACTUAL participants
AZD0186
DRUG
Placebo
DRUG
Lead Sponsor
AstraZeneca
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06671587