Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-26 @ 3:03 PM
Study NCT ID:
NCT04055168
Status:
TERMINATED
Last Update Posted:
2020-12-14
First Post:
2019-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD6615 in Healthy Subjects
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Phase I Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD6615 After Single Dosing to Healthy Subjects
Status:
TERMINATED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
It was decided to not run the Japanese cohorts in the study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be a randomized, single-blind, placebo-controlled, single-ascending dose (SAD), sequential group study. It is a SAD study in healthy Non-Asian subjects (Part 1) and healthy Japanese subjects (Part 2) to assess the safety and tolerability of AZD6615 and to characterize the pharmacokinetics (PK) of AZD6615.
Detailed Description:
This study part is planned to consist of 3 cohorts of Non-Asian subjects (Part 1) and 2 cohorts of Japanese subjects (Part 2). Part 2 will be initiated no earlier than after completion of the last Safety Review Committee (SRC) review in Part 1. Healthy male and/or female subjects aged 20 to 60 years will be included in both Parts 1 and 2 of the study. Female subjects must be of non-childbearing potential. Study Part 1 is planned to be conducted in 24 subjects but may be conducted in up to 40 subjects. Study Part 2 is planned to be conducted in 16 subjects but may be conducted in up to 32 subjects.
Within each cohort of Parts 1 and 2, 6 subjects will be randomized to receive AZD6615 and 2 subjects will be randomized to receive placebo. Dosing and food intake should be supervised and documented by study staff when subjects are in the clinic.
The study will comprise of:
* A Screening Period of maximum 28 days.
* A Dosing Session during which subjects will be resident at the Clinical Unit from the day before IMP administration (Day -1) until at least 78 hours after Investigational medicinal product (IMP) administration; discharged on Day 4.
* A Follow-Up Period of 12 weeks that will consist of 6 Follow-Up Visits, for which the subjects will return to the Clinical Unit at 2, 4, 6, 8, 10, and 12 weeks post-dose.
Within each cohort, site personnel remain blinded until the SRC meeting.
Following review of the data, the SRC may also decide to adjust the following for subsequent cohorts:
* The time window between the sentinel dose group and the main dose group in Part 1.
* The length of the stay at the study site, the timing and number of assessments and/or samples.
* The length of the follow-up period.
* The length of the data collection period for the SRC review.
Within each cohort of Parts 1 and 2, 6 subjects will be randomized to receive AZD6615 and 2 subjects will be randomized to receive placebo. Dosing and food intake should be supervised and documented by study staff when subjects are in the clinic.
The study will comprise of:
* A Screening Period of maximum 28 days.
* A Dosing Session during which subjects will be resident at the Clinical Unit from the day before IMP administration (Day -1) until at least 78 hours after Investigational medicinal product (IMP) administration; discharged on Day 4.
* A Follow-Up Period of 12 weeks that will consist of 6 Follow-Up Visits, for which the subjects will return to the Clinical Unit at 2, 4, 6, 8, 10, and 12 weeks post-dose.
Within each cohort, site personnel remain blinded until the SRC meeting.
Following review of the data, the SRC may also decide to adjust the following for subsequent cohorts:
* The time window between the sentinel dose group and the main dose group in Part 1.
* The length of the stay at the study site, the timing and number of assessments and/or samples.
* The length of the follow-up period.
* The length of the data collection period for the SRC review.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: