Study identifier:D7930C00001
ClinicalTrials.gov identifier:NCT06138795
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2389 After Single and Multiple Ascending Doses to Healthy Participants.
Healthy Participants
Phase 1
Yes
AZD2389, Placebo
All
110
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Aug 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Cohort 1: Part A1 - AZD2389 dose 1/placebo oral administration A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. | Drug: AZD2389 Participants will receive AZD2389 orally as a single ascending dose or multiple ascending dose. Drug: Placebo Participants will receive placebo matching the AZD2389 dose orally as a single ascending dose or multiple ascending dose. |
Experimental: Cohort 2: Part A1 - AZD2389 dose 2/placebo oral administration A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. | Drug: AZD2389 Participants will receive AZD2389 orally as a single ascending dose or multiple ascending dose. Drug: Placebo Participants will receive placebo matching the AZD2389 dose orally as a single ascending dose or multiple ascending dose. |
Experimental: Cohort 3: Part A1 - AZD2389 dose 3 /placebo oral administration A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. | Drug: AZD2389 Participants will receive AZD2389 orally as a single ascending dose or multiple ascending dose. Drug: Placebo Participants will receive placebo matching the AZD2389 dose orally as a single ascending dose or multiple ascending dose. |
Experimental: Cohort 4: Part A1 - AZD2389 dose 4 /placebo oral administration A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. | Drug: AZD2389 Participants will receive AZD2389 orally as a single ascending dose or multiple ascending dose. Drug: Placebo Participants will receive placebo matching the AZD2389 dose orally as a single ascending dose or multiple ascending dose. |
Experimental: Cohort 5: Part A1 - AZD2389 dose 5 /placebo oral administration A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. | Drug: AZD2389 Participants will receive AZD2389 orally as a single ascending dose or multiple ascending dose. Drug: Placebo Participants will receive placebo matching the AZD2389 dose orally as a single ascending dose or multiple ascending dose. |
Experimental: Cohort 6: Part A1 - AZD2389 dose 6 oral administration A total of 6 study participants will receive a single dose of AZD2389. | Drug: AZD2389 Participants will receive AZD2389 orally as a single ascending dose or multiple ascending dose. |
Experimental: Cohort 7: Part A2 - AZD2389 dose 7 /placebo oral administration A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. | Drug: AZD2389 Participants will receive AZD2389 orally as a single ascending dose or multiple ascending dose. Drug: Placebo Participants will receive placebo matching the AZD2389 dose orally as a single ascending dose or multiple ascending dose. |
Experimental: Cohort 8: Part A2 - AZD2389 dose 8 /placebo oral administration A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. | Drug: AZD2389 Participants will receive AZD2389 orally as a single ascending dose or multiple ascending dose. Drug: Placebo Participants will receive placebo matching the AZD2389 dose orally as a single ascending dose or multiple ascending dose. |
Experimental: Cohort 9: Part A2 - AZD2389 dose 9 /placebo oral administration A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. | Drug: AZD2389 Participants will receive AZD2389 orally as a single ascending dose or multiple ascending dose. Drug: Placebo Participants will receive placebo matching the AZD2389 dose orally as a single ascending dose or multiple ascending dose. |
Experimental: Cohort 10: Part A3 - AZD2389 dose 10 /placebo oral administration A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. | Drug: AZD2389 Participants will receive AZD2389 orally as a single ascending dose or multiple ascending dose. Drug: Placebo Participants will receive placebo matching the AZD2389 dose orally as a single ascending dose or multiple ascending dose. |
Experimental: Cohort 11: Part B1 - AZD2389 dose 11 /placebo oral administration A total of 6 study participants will receive multiple doses of AZD2389 and 2 will receive placebo. | Drug: AZD2389 Participants will receive AZD2389 orally as a single ascending dose or multiple ascending dose. Drug: Placebo Participants will receive placebo matching the AZD2389 dose orally as a single ascending dose or multiple ascending dose. |
Experimental: Cohort 12: Part B1 - AZD2389 dose 12 /placebo oral administration A total of 6 study participants will receive multiple doses of AZD2389 and 2 will receive placebo. | Drug: AZD2389 Participants will receive AZD2389 orally as a single ascending dose or multiple ascending dose. Drug: Placebo Participants will receive placebo matching the AZD2389 dose orally as a single ascending dose or multiple ascending dose. |
Experimental: Cohort 13: Part B1 - AZD2389 dose 13 /placebo oral administration A total of 6 study participants will receive multiple doses of AZD2389 and 2 will receive placebo. | Drug: AZD2389 Participants will receive AZD2389 orally as a single ascending dose or multiple ascending dose. Drug: Placebo Participants will receive placebo matching the AZD2389 dose orally as a single ascending dose or multiple ascending dose. |
Experimental: Cohort 14: Part B2- AZD2389 dose 14/placebo oral administration A total of 6 study participants will receive multiple doses of AZD2389 and 2 will receive placebo. | Drug: AZD2389 Participants will receive AZD2389 orally as a single ascending dose or multiple ascending dose. Drug: Placebo Participants will receive placebo matching the AZD2389 dose orally as a single ascending dose or multiple ascending dose. |