Ignite Creation Date:
2025-12-18 @ 8:10 AM
Ignite Modification Date:
2025-12-18 @ 8:10 AM
Study NCT ID:
NCT04622124
Status:
None
Last Update Posted:
2024-08-05 00:00:00
First Post:
2020-10-15 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Safety and Tolerability Study of FCN-207 in Healthy Volunteers
Sponsor:
None
Organization:
Study Overview
Official Title:
A Phase 1, Single-center, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Access the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food-effect of FCN-207 in Healthy Volunteers
Status:
None
Status Verified Date:
2021-11
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, single-center, dose-escalations (SAD and MAD) and food effect study of FCN-207:
Part 1 Single Ascending Dose (SAD) study: randomized, double-blind, placebo-controlled.
Part 2 Food-effect study: single-dose, two-treatment (fasted vs. high-fat meal), two-sequence crossover design.
Part 3 Multiple Ascending Dose (MAD) study: randomized, double-blind, placebo-controlled.
Part 1 Single Ascending Dose (SAD) study: randomized, double-blind, placebo-controlled.
Part 2 Food-effect study: single-dose, two-treatment (fasted vs. high-fat meal), two-sequence crossover design.
Part 3 Multiple Ascending Dose (MAD) study: randomized, double-blind, placebo-controlled.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: