Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05848440
Status:
COMPLETED
Last Update Posted:
2023-12-11
First Post:
2023-03-31
Brief Title:
A Study to Assess the Safety Tolerability and Pharmacokinetics of AZD9550 Following Single Ascending Dose Administration to Healthy Participants
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase I Randomised Single-blind Placebo-controlled Study to Assess the Safety Tolerability and Pharmacokinetics of AZD9550 Following Single Ascending Dose Administration to Healthy Participants
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase I Randomised Single-blind Placebo-controlled Study to Assess the Safety Tolerability and Pharmacokinetics of AZD9550 Following Single Ascending Dose Administration to Healthy Participants
Detailed Description:
This study will be a Phase I First-In-Human FIH randomised single-blind placebo-controlled single ascending dose SAD sequential group study in healthy male and female participants of non- childbearing potential performed at a single study centre
The study consists of 3 parts
Part A SAD up to 5 dose levels of AZD9550 administered subcutaneous SC in healthy participants
Part B 1 dose level of AZD9550 administered SC in healthy participants of Japanese descent
Part C 1 dose level of AZD9550 administered intravenous IV in healthy participants
The study will comprise of
A Screening Period of maximum 28 days
A Treatment Period during which participants will be resident at the Clinical Unit from 2 days before Day -2 investigational medicinal product IMP administration Day 1 until at least 7 days 168 hours Day 8 after IMP administration
Weekly out-clinic visits on Days 15 22 29 and 36
A Follow-up Visit 6 weeks Day 43 after the IMP dose
The study consists of 3 parts
Part A SAD up to 5 dose levels of AZD9550 administered subcutaneous SC in healthy participants
Part B 1 dose level of AZD9550 administered SC in healthy participants of Japanese descent
Part C 1 dose level of AZD9550 administered intravenous IV in healthy participants
The study will comprise of
A Screening Period of maximum 28 days
A Treatment Period during which participants will be resident at the Clinical Unit from 2 days before Day -2 investigational medicinal product IMP administration Day 1 until at least 7 days 168 hours Day 8 after IMP administration
Weekly out-clinic visits on Days 15 22 29 and 36
A Follow-up Visit 6 weeks Day 43 after the IMP dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-003308-34 | EUDRACT_NUMBER | None | None |