NCT04622124

A Safety and Tolerability Study of FCN-207 in Healthy Volunteers

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: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Fochon Pharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This research study is studying an investigational drug called FCN-207 in healthy adult males or females.

Detailed description

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.

Conditions

• Hyperuricemia

Interventions

Type	Name	Description
DRUG	Placebo
DIETARY_SUPPLEMENT	fasted vs. high-fat meal
DRUG	Placebo

Timeline

• Start date: 2020-11-11
• Primary completion: 2021-12-21
• Completion: 2022-06-07
• First posted: 2020-11-09
• Last updated: 2024-08-05

Locations

1 site across 1 country: China