Study identifier:D9440C00002
ClinicalTrials.gov identifier:NCT06491550
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I Randomized, Single-blind, Placebo-controlled, and Sequential Group Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 Following Single and Multiple Ascending Doses via Intravenous Administration, and an Open-label, 2-Period, 2-Sequence, Cross-over Study to Assess the Effects of Intravenous AZD4144 on Rosuvastatin Pharmacokinetics in Healthy Participants
Healthy Participants
Phase 1
Yes
AZD4144- Part A, Placebo- Part A, AZD4144- Part B, Placebo- Part B, Rosuvastatin- Part C, Rosuvastatin and AZD4144 Part C
All
92
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Part A1-Cohort 1 Participants will receive one single ascending dose of AZD4144. | Drug: AZD4144- Part A Part A: Participants will be administered a single dose of AZD4144 on Day 1 via Intravenous (IV) infusion. |
Experimental: Part A1- Cohort 2 Participants will receive one single ascending dose of AZD4144. | Drug: AZD4144- Part A Part A: Participants will be administered a single dose of AZD4144 on Day 1 via Intravenous (IV) infusion. |
Experimental: Part A1-Cohort 3 Participants will receive one single ascending dose of AZD4144. | Drug: AZD4144- Part A Part A: Participants will be administered a single dose of AZD4144 on Day 1 via Intravenous (IV) infusion. |
Experimental: Part A2-Japanese cohort 1 Participants will receive one single ascending dose of AZD4144. | Drug: AZD4144- Part A Part A: Participants will be administered a single dose of AZD4144 on Day 1 via Intravenous (IV) infusion. |
Experimental: Part A2: Japanese Cohort 2 Participants will receive one single ascending dose of AZD4144. | Drug: AZD4144- Part A Part A: Participants will be administered a single dose of AZD4144 on Day 1 via Intravenous (IV) infusion. |
Experimental: Part A3-Chinese Cohort Participants will receive one single ascending dose of AZD4144. | Drug: AZD4144- Part A Part A: Participants will be administered a single dose of AZD4144 on Day 1 via Intravenous (IV) infusion. |
Experimental: Part B1- Cohort 1 Participants will receive multiple ascending doses of AZD4144. | Drug: AZD4144- Part B Part B: Participants will be administered a single dose of AZD4144 on Day 1 and Day 12 via IV infusion. Participants will be administered multiple doses of AZD4144 from Day 4 to Day 11 via IV infusion. |
Experimental: Part B1- Cohort 2 Participants will receive multiple ascending doses of AZD4144. | Drug: AZD4144- Part B Part B: Participants will be administered a single dose of AZD4144 on Day 1 and Day 12 via IV infusion. Participants will be administered multiple doses of AZD4144 from Day 4 to Day 11 via IV infusion. |
Experimental: Part B1- Cohort 3 Participants will receive multiple ascending doses of AZD4144. | Drug: AZD4144- Part B Part B: Participants will be administered a single dose of AZD4144 on Day 1 and Day 12 via IV infusion. Participants will be administered multiple doses of AZD4144 from Day 4 to Day 11 via IV infusion. |
Experimental: Part B2- Japanese Cohort Participants will receive multiple ascending doses of AZD4144. | Drug: AZD4144- Part B Part B: Participants will be administered a single dose of AZD4144 on Day 1 and Day 12 via IV infusion. Participants will be administered multiple doses of AZD4144 from Day 4 to Day 11 via IV infusion. |
Experimental: Part C Cohort- Treatment C1 Participants will receive Rosuvastatin. | Drug: Rosuvastatin- Part C Participants will be administered a single oral dose of 10 mg Rosuvastatin. |
Experimental: Part C cohort- Treatment C2 Participants will receive rosuvastatin and AZD4144. | Drug: Rosuvastatin and AZD4144 Part C Participants will be administered a single oral dose of Rosuvastatin and a single dose of AZD4144 via IV infusion. |
Placebo Comparator: Part A1- Placebo Participants will receive matching placebo. | Drug: Placebo- Part A Part A: Participants will be administered a single dose of placebo on Day 1 via IV infusion. |
Placebo Comparator: Part A2- Placebo Participants will receive matching placebo. | Drug: Placebo- Part A Part A: Participants will be administered a single dose of placebo on Day 1 via IV infusion. |
Placebo Comparator: Part A3- Placebo Participants will receive matching Placebo. | Drug: Placebo- Part A Part A: Participants will be administered a single dose of placebo on Day 1 via IV infusion. |
Placebo Comparator: Part B1- Placebo Participants will receive matching Placebo. | Drug: Placebo- Part B Part B: Participants will be administered a single dose of placebo on Day 1 and Day 12via IV infusion. Participants will be administered multiple doses of placebo from Day 4 to Day 11 via IV infusion. |
Placebo Comparator: Part B2- Placebo Participants will receive matching Placebo. | Drug: Placebo- Part B Part B: Participants will be administered a single dose of placebo on Day 1 and Day 12via IV infusion. Participants will be administered multiple doses of placebo from Day 4 to Day 11 via IV infusion. |