CompletedPhase 1

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5148 in Healthy Adults

United States84 participantsStarted 2024-06-24

Plain-language summary

The purpose of this study is to measure safety, tolerability, and pharmacokinetics (PK) of a single dose of AZD5148 administered via intravenous (IV) bolus or intramuscular (IM) injection in healthy participants

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Postmenopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and follicular stimulating hormone (FSH) levels in the postmenopausal range.
✓. Documentation of irreversible surgical sterilization by complete hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion.
✓. Participant with Chinese ancestry, born in mainland China, Hong Kong, or Taiwan.
✓. Participant is the descendant of 4 ethnic Chinese grandparents and 2 ethnic Chinese parents.
✓. Participant has lived outside China for ≤ 10 years at the time of Screening.
✓. Exhibits no significant change in lifestyle, including diet, since leaving China.

What they're measuring

Number of participants with adverse events (AEs).

Timeframe: From Day -1 to Day 91

Number of participants with serious adverse events (SAEs) and adverse events of special interest (AESIs)

Timeframe: From Screening (Day -28 to Day -1) to final Follow-up Visit (Day 361 ± 14)

Trial details

NCT IDNCT06469151

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-22

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