Healthy Participants Clinical Trial
Official title:
A Phase I Randomized Single-blind Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD6234 Following Single Ascending Dose Administration to Healthy Subjects Who Are Overweight or Obese
A study in healthy male and female participants of non-childbearing potential who are overweight or obese.
The study will comprise of: - A Screening Period of maximum 28 days. - A Treatment Period during which participants will be resident at the Clinical Unit from three days before (Day -3 ) Investigational Medicinal Product (IMP) administration (Day 1) until at least 4 days (96 hours) after IMP administration, participants will then be discharged on the morning of Day 5. - Weekly outpatient visits on Days 8, 15, 22, 29, and 36 for blood sample collection, Electrocardiogram (ECGs), and adverse events (AE) recording. - A Follow-up Visit 6 weeks (Day 43) after the last IMP dose. Furthermore, 3 dose levels of AZD6234 for Subcutaneous (SC) administration (Cohorts 1 to 3) and one dose level for Intravenous (IV) administration (Cohort 4) are planned to be investigated in healthy participants who are overweight or obese. The IV cohort (Cohort 4) can begin in parallel or after Cohort 3. One dose level for SC administration is planned to be investigated in Japanese participants only (Cohort 5), and up to 3 additional dose levels for SC administration are planned to be investigated in healthy participants (Cohort 6 to 8). Depending on the findings, additional (optional) dose level cohorts may be added at the discretion of the Sponsor. ;
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