Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT04527718
Status:
COMPLETED
Last Update Posted:
2022-11-10
First Post:
2020-07-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
Sponsor:
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase 1 Randomized, Double Blinded, Placebo-Controlled Single Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of 611 in Adult Healthy Male and Female Volunteers
Status:
COMPLETED
Status Verified Date:
2022-11
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 1 randomized, double blinded, placebo-controlled, single dose escalation study to evaluate the safety, tolerability, and PK of 611 in healthy volunteers.
Detailed Description:
Total duration of the study period per subject is about 4 months broken down as follows:
The screening period is up to 28 days, one dose treatment, and follow- up period is up to 71±7 days (90±9 days for Cohorts 1 and 2).
The screening period is up to 28 days, one dose treatment, and follow- up period is up to 71±7 days (90±9 days for Cohorts 1 and 2).
Study Oversight
Has Oversight DMC:
True
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?: