A Study to Assess Safety, Tolerability, and Pharmacokinetics of AZD0186

  • STATUS
    Recruiting
  • participants needed
    72
  • sponsor
    AstraZeneca
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Updated on 1 February 2023
Accepts healthy volunteers

Summary

This study will assess the safety, tolerability, and pharmacokinetics of AZD0186 following single ascending doses (SAD) via oral administration in healthy adult participants.

Description

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.

Details
Condition Type 2 Diabetes
Age 18years - 55years
Treatment Placebo, AZD0186
Clinical Study IdentifierNCT05694741
SponsorAstraZeneca
Last Modified on1 February 2023

Eligibility

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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