Study identifier:D8820C00002
ClinicalTrials.gov identifier:NCT06469151
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5148 in Healthy Adults
Healthy Participants
Phase 1
Yes
AZD5148, Placebo
All
84
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Other
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Cohort 1: AZD5148 (dose 1) IM Participants will receive AZD5148 (dose 1) or matching placebo as an IM injection | Drug: AZD5148 Participants will receive AZD5148 (dose 1, dose 2, dose 3 or dose 4) as an IM injection or IV bolus Drug: Placebo Participants will receive matching doses of placebo as an IM injection or IV bolus Other Name: Placebo |
Experimental: Cohort 2a: AZD5148 (dose 2) IM Participants will receive AZD5148 (dose 2) or matching placebo as an IM injection | Drug: AZD5148 Participants will receive AZD5148 (dose 1, dose 2, dose 3 or dose 4) as an IM injection or IV bolus Drug: Placebo Participants will receive matching doses of placebo as an IM injection or IV bolus Other Name: Placebo |
Experimental: Cohort 2b: AZD5148 (dose 2) IM Participants of Chinese descent will receive AZD5148 (dose 2) or matching placebo as an IM injection | Drug: AZD5148 Participants will receive AZD5148 (dose 1, dose 2, dose 3 or dose 4) as an IM injection or IV bolus Drug: Placebo Participants will receive matching doses of placebo as an IM injection or IV bolus Other Name: Placebo |
Experimental: Cohort 3: AZD5148 (dose 2) IV Participants will receive AZD5148 (dose 2) or matching placebo as an IV bolus | Drug: AZD5148 Participants will receive AZD5148 (dose 1, dose 2, dose 3 or dose 4) as an IM injection or IV bolus Drug: Placebo Participants will receive matching doses of placebo as an IM injection or IV bolus Other Name: Placebo |
Experimental: Cohort 4a: AZD5148 (dose 3) IV Participants will receive AZD5148 (dose 3) or matching placebo as an IV bolus | Drug: AZD5148 Participants will receive AZD5148 (dose 1, dose 2, dose 3 or dose 4) as an IM injection or IV bolus Drug: Placebo Participants will receive matching doses of placebo as an IM injection or IV bolus Other Name: Placebo |
Experimental: Cohort 4b: AZD5148 (dose 3) IV Participants of Chinese descent will receive AZD5148 (dose 3) or matching placebo as an IV bolus | Drug: AZD5148 Participants will receive AZD5148 (dose 1, dose 2, dose 3 or dose 4) as an IM injection or IV bolus Drug: Placebo Participants will receive matching doses of placebo as an IM injection or IV bolus Other Name: Placebo |
Experimental: Cohort 5: AZD5148 (dose 4) IV Participants will receive AZD5148 (dose 4) or matching placebo as an IV bolus | Drug: AZD5148 Participants will receive AZD5148 (dose 1, dose 2, dose 3 or dose 4) as an IM injection or IV bolus Drug: Placebo Participants will receive matching doses of placebo as an IM injection or IV bolus Other Name: Placebo |