Study identifier:D8750C00001
ClinicalTrials.gov identifier:NCT05511025
EudraCT identifier:N/A
CTIS identifier:N/A
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
Healthy Participants
Phase 1
Yes
AZD6234, Placebo
All
54
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
-
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.
Location
Location
Glendale, CA, United States, 91206
Location
Brooklyn, MD, United States, 21225
Arms | Assigned Interventions |
---|---|
Experimental: Cohort 1 Participants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC | Drug: AZD6234 Participants will receive a single dose of AZD6234 as a solution via SC or IV injection Drug: Placebo Participants will receive matching volumes of the placebo as a solution via SC or IV injection Combination Product: Acetaminophen Participants will receive a single dose of acetaminophen as part of a meal |
Experimental: Cohort 2 Participants will receive a single dose of AZD6234 via an SC injection and matching volume of the placebo as a solution via SC injection | Drug: AZD6234 Participants will receive a single dose of AZD6234 as a solution via SC or IV injection Drug: Placebo Participants will receive matching volumes of the placebo as a solution via SC or IV injection Combination Product: Acetaminophen Participants will receive a single dose of acetaminophen as part of a meal |
Experimental: Cohort 3 Participants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC injection | Drug: AZD6234 Participants will receive a single dose of AZD6234 as a solution via SC or IV injection Drug: Placebo Participants will receive matching volumes of the placebo as a solution via SC or IV injection Combination Product: Acetaminophen Participants will receive a single dose of acetaminophen as part of a meal |
Experimental: Cohort 4 Participants will receive single ascending doses of AZD6234 via IV injection and matching volumes of the placebo as a solution via IV injection | Drug: AZD6234 Participants will receive a single dose of AZD6234 as a solution via SC or IV injection Drug: Placebo Participants will receive matching volumes of the placebo as a solution via SC or IV injection Combination Product: Acetaminophen Participants will receive a single dose of acetaminophen as part of a meal |
Experimental: Cohort 5 One dose level for SC administration is planned to be investigated for Japanese participants only | Drug: AZD6234 Participants will receive a single dose of AZD6234 as a solution via SC or IV injection Drug: Placebo Participants will receive matching volumes of the placebo as a solution via SC or IV injection Combination Product: Acetaminophen Participants will receive a single dose of acetaminophen as part of a meal |
Experimental: Cohort 6 Participants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC injection | Drug: AZD6234 Participants will receive a single dose of AZD6234 as a solution via SC or IV injection Drug: Placebo Participants will receive matching volumes of the placebo as a solution via SC or IV injection Combination Product: Acetaminophen Participants will receive a single dose of acetaminophen as part of a meal |
Experimental: Cohort 7 Participants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC injection | Drug: AZD6234 Participants will receive a single dose of AZD6234 as a solution via SC or IV injection Drug: Placebo Participants will receive matching volumes of the placebo as a solution via SC or IV injection Combination Product: Acetaminophen Participants will receive a single dose of acetaminophen as part of a meal |
Experimental: Cohort 8 Participants will receive AZD6234 via SC injection and matching volumes of placebo as a solution via SC injection | Drug: AZD6234 Participants will receive a single dose of AZD6234 as a solution via SC or IV injection Drug: Placebo Participants will receive matching volumes of the placebo as a solution via SC or IV injection Combination Product: Acetaminophen Participants will receive a single dose of acetaminophen as part of a meal |
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