Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06491550 | A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 as Well as the Impact of AZD4144 on the Pharmacokinetics of Rosuvastatin and Furosemide in Healthy Participants | PHASE1 | COMPLETED | 91 | — | — | Jul 15, 2024 | Jun 11, 2025 | Jul 4, 2025 | 2 | United States |
| NCT06122714 | A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 Following Single and Multiple Ascending Doses Via Oral Administration to Healthy Participants | PHASE1 | COMPLETED | 95 | — | — | Nov 7, 2023 | Dec 4, 2024 | Dec 13, 2024 | 2 | United States |
To assess the safety and tolerability of AZD4144 following IV administration of single (Part A) and multiple (Part B) ascending doses in healthy participants.
To evaluate the effect of AZD4144 on the PK of rosuvastatin and furosemide in healthy participants.
To evaluate the effect of AZD4144 on the PK of rosuvastatin and furosemide in healthy participants.
To evaluate the effect of AZD4144 on the PK of rosuvastatin and furosemide in healthy participants.
To assess the safety and tolerability of AZD4144 following oral administration of single and multiple ascending doses (Part A and Part B)
| Arm | Type | Description |
|---|---|---|
| Part A1-Cohort 1 | EXPERIMENTAL | Participants will receive one single ascending dose of AZD4144. |
| Part A1- Cohort 2 | EXPERIMENTAL | Participants will receive one single ascending dose of AZD4144. |
| Part A1-Cohort 3 | EXPERIMENTAL | Participants will receive one single ascending dose of AZD4144. |
| Part A2-Japanese cohort 1 | EXPERIMENTAL | Participants will receive one single ascending dose of AZD4144. |
| Part A2: Japanese Cohort 2 | EXPERIMENTAL | Participants will receive one single ascending dose of AZD4144. |
| Part A3-Chinese Cohort | EXPERIMENTAL | Participants will receive one single ascending dose of AZD4144. |
| Part B1- Cohort 1 | EXPERIMENTAL | Participants will receive multiple ascending doses of AZD4144. |
| Part B1- Cohort 2 | EXPERIMENTAL | Participants will receive multiple ascending doses of AZD4144. |
| Part B1- Cohort 3 | EXPERIMENTAL | Participants will receive multiple ascending doses of AZD4144. |
| Part B2- Japanese Cohort | EXPERIMENTAL | Participants will receive multiple ascending doses of AZD4144. |
| Part C Cohort- Treatment C1 | EXPERIMENTAL | Participants will receive rosuvastatin and furosemide. |
| Part C cohort- Treatment C2 | EXPERIMENTAL | Participants will receive rosuvastatin, furosemide, and AZD4144. |
| Part A1- Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo. |
| Part A2- Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo. |
| Part A3- Placebo | PLACEBO_COMPARATOR | Participants will receive matching Placebo. |
| Part B1- Placebo | PLACEBO_COMPARATOR | Participants will receive matching Placebo. |
| Part B2- Placebo | PLACEBO_COMPARATOR | Participants will receive matching Placebo. |
| Part A1 (healthy participants) Cohort 1 | EXPERIMENTAL | Participants will receive one single ascending dose of AZD4144. |
| Part A1 (healthy participants) Cohort 2 | EXPERIMENTAL | Participants will receive one single ascending dose of AZD4144. |
| Part A1 (healthy participants) Cohort 3 | EXPERIMENTAL | Participants will receive one single ascending dose of AZD4144. |
| Part A1 (healthy participants) Cohort 4 | EXPERIMENTAL | Participants will receive one single ascending dose of AZD4144. |
| Part A1 (healthy participants) Cohort 5 | EXPERIMENTAL | Participants will receive one single ascending dose of AZD4144. |
| Part A1 (healthy participants) Cohort 6 | EXPERIMENTAL | Participants will receive one single ascending dose of AZD4144. |
| Part A1 (healthy participants) placebo | PLACEBO_COMPARATOR | Participants will receive matching Placebo. |
| Part A2 (healthy Japanese participants) Cohort 1 | EXPERIMENTAL | Participants will receive one single ascending dose of AZD4144. |
| Part A2 (healthy Japanese participants) Cohort 2 | EXPERIMENTAL | Participants will receive one single ascending dose of AZD4144. |
| Part A2 (healthy Japanese participants) placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo. |
| Part A3 (healthy Chinese participants) Cohort 1 | EXPERIMENTAL | Participants will receive one single ascending dose of AZD4144. |
| Part A3 (healthy Chinese participants) placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo. |
| Part B1 (healthy participants) Cohort 1 | EXPERIMENTAL | Participants will receive one multiple ascending dose of AZD4144. |
| Part B1 (healthy participants) Cohort 2 | EXPERIMENTAL | Participants will receive one multiple ascending dose of AZD4144. |
| Part B1 (healthy participants) Cohort 3 | EXPERIMENTAL | Participants will receive one multiple ascending dose of AZD4144. |
| Part B1 (healthy participants) placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo. |
| Part B2 (healthy Japanese participants) Cohort 1 | EXPERIMENTAL | Participants will receive one multiple ascending dose of AZD4144. |
| Part B2 (healthy Japanese participants) placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo. |
| Name | Type | Description |
|---|---|---|
| AZD4144- Part A | DRUG | Part A: Participants will be administered a single dose of AZD4144 on Day 1 via Intravenous (IV) infusion. |
| Placebo- Part A | DRUG | Part A: Participants will be administered a single dose of placebo on Day 1 via IV infusion. |
| AZD4144- Part B | DRUG | 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. |
| Placebo- Part B | DRUG | 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. |
| Rosuvastatin and Furosemide- Part C | DRUG | Participants will be administered a single oral dose of 10 mg Rosuvastatin and 1 mg Furosemide. |
| Rosuvastatin, Furosemide, and AZD4144 Part C | DRUG | Participants will be administered a single oral dose of 10 mg Rosuvastatin, 1 mg Furosemide and a single dose of AZD4144 via IV infusion. |
| AZD4144 Part A | DRUG | Part A: Participants will be administered a single oral dose on Day 1. |
| AZD4144 Part B | DRUG | Part B: Participants will be administered a single dose on Day 1, and repeated dosing will commence from Day 4 until Day 11 (inclusive) and a single dose on Day 12. |
| Placebo Part A | DRUG | Part A: Participants will be administered a single oral dose of matching placebo on Day 1. |
| Placebo Part B | DRUG | Part B: Participants will be administered a single dose of matching placebo on Day 1, and repeated dosing will commence from Day 4 until Day 11 (inclusive) and a single dose on Day 12. |
Inclusion Criteria: * All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit. * Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception. * Female...