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.

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: FL058; Drug: FL058

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Huashan Hospital Affiliated to Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy adults aged between 18 and 45 years (inclusive).
2. Body mass index (BMI) ranges from 19 to 26 kg/m2 (inclusive), and the body weight is ≥50kg.
3. Good general health as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests.
4. Provide voluntary written informed consent prior to any study procedures and are willing and able to comply with the prescribed treatment protocol and evaluations.

Exclusion Criteria:

1. Concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological disorders.
2. Positive screen result for HBsAg, HCV-Ab, or HIV-Ab at screening.
3. History of clinically significant food or drug allergy.
4. A QT interval corrected using Fridericia's formula >450 msec.
5. eGFR<90mL/min/1.73m2.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A：FL058; a single ascending dose (SAD) of intravenous (IV) FL058(2500mg~3000mg)	Drug: FL058; 2500mg、3000mg; Drug: FL058; 500mg、1000mg、2000mg
Placebo Comparator: Part A：Placebo; FL058 Placebo	Drug: Placebo; empty bottle
Experimental: Part B：FL058; a multiple ascending dose (MAD) of intravenous (IV) FL058(500mg~2000mg)	Drug: FL058; 2500mg、3000mg; Drug: FL058; 500mg、1000mg、2000mg
Placebo Comparator: Part B：Placebo; FL058 Placebo	Drug: Placebo; empty bottle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part A:Number of patients with adverse events [Safety and Tolerability]	Day 1 to Day 7
Part B:Number of patients with adverse events [Safety and Tolerability]	Day 1 to Day 12

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2020
• Primary Completion (Actual): July 27, 2020
• Study Completion (Actual): July 27, 2020

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: FL058-I-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No