A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 Following Single and Multiple Ascending Doses Via Oral Administration to Healthy Participants
- Conditions
- Healthy Participants
- Interventions
- Drug: AZD4144 Part ADrug: Placebo Part ADrug: AZD4144 Part BDrug: Placebo Part B
- Registration Number
- NCT06122714
- Lead Sponsor
- AstraZeneca
- Brief Summary
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of AZD4144 administered orally in healthy participants.
- Detailed Description
This is a Phase I, first time-in human (FTiH), randomised, single-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) sequential group study in healthy participants.
Part A consists of 3 parts:
Part A1 (healthy participants) Part A2 (healthy Japanese participants) and Part A3 (healthy Chinese participants)
Part B consists of 2 parts:
Part B1 (healthy participants) Part B2 (healthy Japanese participants)
Both Part A and Part B of the study will comprise of a screening period of maximum 28 days. The treatment period would last from Day -1 to Day 4 in Part A and from Day -1 to Day 15 in Part B of the study. A follow up visit will be performed on Day 10 + 3 days for Part A and on Day 20 + 3 days for Part B.
Each participant will participate for about 6 weeks in Part A of the study and for about 7 weeks in Part B of the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A1 (healthy participants) Cohort 1 AZD4144 Part A Participants will receive one single ascending dose of AZD4144. Part A1 (healthy participants) Cohort 2 AZD4144 Part A Participants will receive one single ascending dose of AZD4144. Part A1 (healthy participants) Cohort 3 AZD4144 Part A Participants will receive one single ascending dose of AZD4144. Part A1 (healthy participants) Cohort 4 AZD4144 Part A Participants will receive one single ascending dose of AZD4144. Part A1 (healthy participants) Cohort 5 AZD4144 Part A Participants will receive one single ascending dose of AZD4144. Part A1 (healthy participants) Cohort 6 AZD4144 Part A Participants will receive one single ascending dose of AZD4144. Part A1 (healthy participants) placebo Placebo Part A Participants will receive matching Placebo. Part A2 (healthy Japanese participants) Cohort 1 AZD4144 Part A Participants will receive one single ascending dose of AZD4144. Part A2 (healthy Japanese participants) Cohort 2 AZD4144 Part A Participants will receive one single ascending dose of AZD4144. Part A2 (healthy Japanese participants) placebo Placebo Part A Participants will receive matching placebo. Part A3 (healthy Chinese participants) Cohort 1 AZD4144 Part A Participants will receive one single ascending dose of AZD4144. Part A3 (healthy Chinese participants) placebo Placebo Part A Participants will receive matching placebo. Part B1 (healthy participants) Cohort 1 AZD4144 Part B Participants will receive one multiple ascending dose of AZD4144. Part B1 (healthy participants) Cohort 2 AZD4144 Part B Participants will receive one multiple ascending dose of AZD4144. Part B1 (healthy participants) Cohort 3 AZD4144 Part B Participants will receive one multiple ascending dose of AZD4144. Part B1 (healthy participants) placebo Placebo Part B Participants will receive matching placebo. Part B2 (healthy Japanese participants) Cohort 1 AZD4144 Part B Participants will receive one multiple ascending dose of AZD4144. Part B2 (healthy Japanese participants) placebo Placebo Part B Participants will receive matching placebo.
- Primary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) Part A: From screening (Day -28 to Day -2) to Day 10; Part B: From screening (Day -28 to Day-2) to Day 20 To assess the safety and tolerability of AZD4144 following oral administration of single and multiple ascending doses (Part A and Part B)
- Secondary Outcome Measures
Name Time Method Maximum observed plasma (peak) drug concentration (Cmax) Part A: Day 1 to Day 4. and Day 10; Part B: Day 1 to Day 15 and Day 20 To characterise the single dose and steady state PK of AZD4144 following oral administration of single and multiple ascending doses (Part A and Part B).
Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast) Part A: Day 1 to Day 4. and Day 10; Part B: Day 1 to Day 15 and Day 20 To characterise the single dose and steady state PK of AZD4144 following oral administration of single and multiple ascending doses (Part A and Part B)
Area under plasma concentration-time curve from zero to infinity (AUC0-inf) Part A: Day 1 to Day 4. and Day 10; Part B: Day 1 to Day 15 and Day 20 To characterise the single dose and steady state PK of AZD4144 following oral administration of single and multiple ascending doses (Part A and Part B)
Renal clearance of drug from plasma (CLR) Part A: Day 1 to Day 4. and Day 10; Part B: Day 1 to Day 15 and Day 20 To characterise the single dose and steady state PK of AZD4144 following oral administration of single and multiple ascending doses (Part A and Part B)
PD analysis: Levels of disease-specific biomarkers Part A: Day 1 to Day 4 and Day 10; Part B: Day -1, Day 1 to Day 4, Day 12 to Day 15 and Day 20 To assess the effect of AZD4144 on levels of disease-specific biomarkers.
Trial Locations
- Locations (1)
Research Site
🇺🇸Brooklyn, Maryland, United States