TerminatedPhase 1

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral AZD0233 Compared With Placebo in Healthy Adult Participants.

Stopped: The study has been terminated due to adverse finding in a non-clinical, chronic toxicology study.

United States84 participantsStarted 2024-04-01

Plain-language summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of AZD0233 following single and multiple ascending dose (SAD and MAD) administration in healthy participants.

Who can participate

Age range18 Years – 50 Years

SexALL

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Inclusion criteria

✓. Post-menopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and follicle-stimulating hormone (FSH) levels in the post-menopausal range.
✓. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation.

What they're measuring

Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Timeframe: From screening (Day -28) to follow-up visit (Day 17)

Trial details

NCT IDNCT06381466

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-30

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