Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06385964
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-23
Brief Title:
A Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of SHR-4597 Inhalation in Healthy Subjects and Asthmatic Patients
Sponsor:
Guangdong Hengrui Pharmaceutical Co Ltd
Organization:
Guangdong Hengrui Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase I Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Dose of SHR-4597 Inhalation in Healthy Subjects and Asthmatic Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
The primary objective of this randomized double-blind singlemultiple ascending dose placebo-controlled Phase I clinical trial was to evaluate the safety and tolerability of SHR-4597 in healthy subjects and asthmatic patients The study consists of two parts Part 1 involves single ascending inhalation dose in healthy subjects Part 2 involves multiple ascending inhalation dose in asthmatic patients further divided into Part 2A multiple ascending inhalation dose in mild to moderate asthmatic patients and Part 2B multiple ascending inhalation dose in moderate to severe asthmatic patients Subsequent lung pharmacokinetic studies of SHR-4597 inhalation will be conducted based on patients PKPD data
Detailed Description:
None
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