A Single and Multiple Ascending Dose Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2389 in Healthy Participants
Status and phase
Completed
Phase 1
Conditions
Healthy Participants
Treatments
Drug: AZD2389
Drug: Placebo
Details and patient eligibility
About
This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD2389 following single and multiple dose administration (SAD/MAD) to healthy participants.
Full description
This is a Phase I, First In Human (FIH), randomized, single-blind, placebo-controlled, single and multiple ascending dose study in healthy male and/or female participants of non-childbearing potential including healthy participants of Chinese and Japanese ethnicity performed at a single center.
The study consists of 2 parts: Part A and Part B. Part A has been planned to be conducted with 78 participants and Part B has been planned to be conducted with 32 participants.
Each participant in Part A and Part B will be involved in the study for up to 8 weeks.
Enrollment
120 patients
Sex
All
Ages
18 to 55 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- Healthy male and female (of non-childbearing potential) participants with suitable veins for cannulation or repeated venipuncture.
- For the healthy Japanese cohorts (Parts A2 and B2): healthy participants are to be Japanese (e.g., natives of Japan or Japanese Americans), defined as having both parents and 4 grandparents who are Japanese. This includes healthy second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.
- For the healthy Chinese cohort (Part A3): healthy participants are to be Chinese defined as having both parents and 4 grandparents who are ethnically Chinese. This includes second and third generation Chinese whose parents or grandparents are living in a country other than China.
Exclusion criteria
- Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
- Known or suspected history of alcohol or drug abuse and smokers.
- Plasma donation within one month of the Screening Visit or any blood donation/blood loss > 500 mL during the 3 months prior to the Screening Visit.
- History of coagulation or bleeding disorders or use of anti-platelets/anti-coagulants during the 3 months prior to the Screening Visit, as judged by the investigator.
- History of hypersensitivity as judged by the investigator, to drugs with a similar chemical structure or class.
- History of severe dermatological disorders, eg, bullous pemphigoid or Stevens-Johnson syndrome, or clinically significant new or healing wounds in areas of the body not always covered by clothing such as face, forearm, and lower leg, as judged by the investigator.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Sequential Assignment
Masking
Single Blind
120 participants in 14 patient groups
Cohort 1: Part A1 - AZD2389 dose 1/placebo oral administration
Experimental group
Description:
A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo.
Treatment:
Drug: Placebo
Drug: AZD2389
Cohort 2: Part A1 - AZD2389 dose 2/placebo oral administration
Experimental group
Description:
A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo.
Treatment:
Drug: Placebo
Drug: AZD2389
Cohort 3: Part A1 - AZD2389 dose 3 /placebo oral administration
Experimental group
Description:
A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo.
Treatment:
Drug: Placebo
Drug: AZD2389
Cohort 4: Part A1 - AZD2389 dose 4 /placebo oral administration
Experimental group
Description:
A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo.
Treatment:
Drug: Placebo
Drug: AZD2389
Cohort 5: Part A1 - AZD2389 dose 5 /placebo oral administration
Experimental group
Description:
A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo.
Treatment:
Drug: Placebo
Drug: AZD2389
Cohort 6: Part A1 - AZD2389 dose 6 oral administration
Experimental group
Description:
A total of 6 study participants will receive a single dose of AZD2389.
Treatment:
Drug: AZD2389
Cohort 7: Part A2 - AZD2389 dose 7 /placebo oral administration
Experimental group
Description:
A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo.
Treatment:
Drug: Placebo
Drug: AZD2389
Cohort 8: Part A2 - AZD2389 dose 8 /placebo oral administration
Experimental group
Description:
A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo.
Treatment:
Drug: Placebo
Drug: AZD2389
Cohort 9: Part A2 - AZD2389 dose 9 /placebo oral administration
Experimental group
Description:
A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo.
Treatment:
Drug: Placebo
Drug: AZD2389
Cohort 10: Part A3 - AZD2389 dose 10 /placebo oral administration
Experimental group
Description:
A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo.
Treatment:
Drug: Placebo
Drug: AZD2389
Cohort 11: Part B1 - AZD2389 dose 11 /placebo oral administration
Experimental group
Description:
A total of 6 study participants will receive multiple doses of AZD2389 and 2 will receive placebo.
Treatment:
Drug: Placebo
Drug: AZD2389
Cohort 12: Part B1 - AZD2389 dose 12 /placebo oral administration
Experimental group
Description:
A total of 6 study participants will receive multiple doses of AZD2389 and 2 will receive placebo.
Treatment:
Drug: Placebo
Drug: AZD2389
Cohort 13: Part B1 - AZD2389 dose 13 /placebo oral administration
Experimental group
Description:
A total of 6 study participants will receive multiple doses of AZD2389 and 2 will receive placebo.
Treatment:
Drug: Placebo
Drug: AZD2389
Cohort 14: Part B2- AZD2389 dose 14/placebo oral administration
Experimental group
Description:
A total of 6 study participants will receive multiple doses of AZD2389 and 2 will receive placebo.
Treatment:
Drug: Placebo
Drug: AZD2389
Trial contacts and locations
1
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Central trial contact
AstraZeneca Clinical Study Information Center
Data sourced from clinicaltrials.gov
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