NCT05055687

Evaluation of the Safety, Tolerability and Pharmacokinetics of Intravenous FL058 Administered in Healthy Subjects(SAD/MAD)

A Randomized, Double-Blind, Single- Multiple Dose, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of FL058 for Injection in Healthy Chinese Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety,tolerability and pharmacokinetics of single-multiple intravenous doses of FL058 in healthy Chinese subjects.

Detailed description

This study is divided into two parts: A and B.Part A discusses the safety and tolerability of IV FL058 single ascending dose (SAD) in two cohorts. Part B discusses the safety and tolerability of intravenous injection of FL058 in multiple dose (MAD) in three cohorts.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	FL058	2500mg、3000mg
DRUG	Placebo	empty bottle
DRUG	FL058	500mg、1000mg、2000mg
DRUG	Placebo	empty bottle

Timeline

• Start date: 2020-07-05
• Primary completion: 2020-07-27
• Completion: 2020-07-27
• First posted: 2021-09-24
• Last updated: 2021-09-24

Locations

1 site across 1 country: China