Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-01-17 @ 1:04 PM
Study NCT ID:
NCT05043792
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2021-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Dose of TT-00920 in Healthy Subjects
Sponsor:
TransThera Sciences (Nanjing), Inc.
Organization:
Study Overview
Official Title:
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study of TT-00920 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2023-10
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 double-blind, randomized, placebo-controlled, multiple ascending dose escalation study of TT-00920 in healthy subjects.
Detailed Description:
This is a double-blind, randomized, placebo-controlled, multiple ascending dose escalation study of TT-00920 in healthy subjects. Each dosing cohort will be comprised of 10 randomized subjects dosed three times daily for 13 days and one time for 1 day. The study will consist of a Screening Period, an In-house Period and a Follow-up.
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?:
False
Is an FDA AA801 Violation?: