Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-03-05 @ 5:04 AM
Study NCT ID:
NCT03918967
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2019-04-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 or CT-G11 and Food Effect of CT-G20 in Human Participants
Sponsor:
Celltrion
Organization:
Study Overview
Official Title:
A Two-segment Phase I, Randomized, Double-Blind, Placebo-Controlled, Sequential, Ascending Single and Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G11 and CT-G20 in Healthy Volunteers (Part 1 and Part 2) and Open Label, Balanced, Randomized, Two-period, Two-Sequence Crossover Study to Assess the Effect of Food on the Pharmacokinetics of CT-G20 in Healthy Volunteers (Part 3)
Status:
COMPLETED
Status Verified Date:
2020-06
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 purpose of this study is to establish safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20 or CT-11 and to evaluate potential effect of food on pharmacokinetics of CT-G20 in human participants. It will be conducted in three parts, as described below:
* Part I will be a randomized, double-blind, placebo-controlled, sequential, single ascending dose study.
* Part II will be a randomized, double-blind, placebo-controlled, sequential, multiple ascending dose study.
* Part III will be a randomized, open-label, balanced, two-period, two-sequence crossover, food effect study.
* Part I will be a randomized, double-blind, placebo-controlled, sequential, single ascending dose study.
* Part II will be a randomized, double-blind, placebo-controlled, sequential, multiple ascending dose study.
* Part III will be a randomized, open-label, balanced, two-period, two-sequence crossover, food effect study.
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?: