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, Acetaminophen
All
54
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Dec 2023 by AstraZeneca
AstraZeneca
-
No locations available
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 |