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

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple Ascending-dose Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous FL058 and Meropenem Alone and in Combination in Healthy Chinese Subjects

Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of FL058 and Meropenem Alone and in Combination following Single and Multiple Doses in Healthy Adult Subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: FL058 500mg and Meropenem 1000mg（ IV 120min）; Drug: FL058 Placebo and Meropenem 1000mg（ IV 120min）; Drug: FL058 1000mg（ IV 120min）; Drug: FL058 Placebo （ IV 120min）; Drug: Meropenem 1000 mg （ IV 120min）; Drug: Meropenem Placebo （ IV 120min）; Drug: FL058 1000mg and Meropenem 1000mg （ IV 120min）; Drug: FL058 Placebo and Meropenem 1000mg （ IV 120min）; Drug: FL058 1000mg and Meropenem 2000mg （ IV 120min）; Drug: FL058 Placebo and Meropenem 2000m（ IV 120min）; Drug: FL058 1000mg and Meropenem 2000mg （ IV 180min）; Drug: FL058 Placebo and Meropenem 2000m（ IV 180min）; Drug: FL058 2000mg and Meropenem 2000mg（ IV 180min）; Drug: FL058 Placebo and Meropenem 2000mg（ IV 180min）

• Study Type: Interventional
• Enrollment (Actual): 40
• 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: No
• 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

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FL058 500mg and Meropenem 1000mg; FL058 500mg and Meropenem 1000mg (8 subjects); FL058 Placebo and Meropenem 1000mg(2 subjects)	Drug: FL058 500mg and Meropenem 1000mg（ IV 120min）; D1 qd; D2~ D8 q8h; D9 qd; Drug: FL058 Placebo and Meropenem 1000mg（ IV 120min）; D1 qd; D2~ D8 q8h; D9 qd
Experimental: FL058 1000mg and Meropenem 1000mg; D1 FL058 1000mg(8 subjects) and FL058 Placebo(2 subjects); D4 Meropenem 1000mg(8 subjects) and Meropenem Placebo(2 subjects); D7~ D15 FL058 1000mg and Meropenem 1000mg (8 subjects); FL058 Placebo and Meropenem 1000mg(2 subjects)	Drug: FL058 1000mg（ IV 120min）; D1 qd; Drug: FL058 Placebo （ IV 120min）; D1 qd; Drug: Meropenem 1000 mg （ IV 120min）; D4 qd; Drug: Meropenem Placebo （ IV 120min）; D4 qd; Drug: FL058 1000mg and Meropenem 1000mg （ IV 120min）; D7 qd; D8~ D14 q8h; D15 qd; Drug: FL058 Placebo and Meropenem 1000mg （ IV 120min）; D7 qd; D8~ D14 q8h; D15 qd;
Experimental: FL058 1000mg and Meropenem 2000mg (IV 120min); FL058 1000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects)	Drug: FL058 1000mg and Meropenem 2000mg （ IV 120min）; D1 qd; D2~ D8 q8h; D9 qd; Drug: FL058 Placebo and Meropenem 2000m（ IV 120min）; D1 qd; D2~ D8 q8h; D9 qd
Experimental: FL058 1000mg and Meropenem 2000mg (IV 180min); FL058 1000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects)	Drug: FL058 1000mg and Meropenem 2000mg （ IV 180min）; D1 qd; D2~ D8 q8h; D9 qd; Drug: FL058 Placebo and Meropenem 2000m（ IV 180min）; D1 qd; D2~ D8 q8h; D9 qd
Experimental: FL058 2000mg and Meropenem 2000mg; FL058 2000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects)	Drug: FL058 2000mg and Meropenem 2000mg（ IV 180min）; D1 qd; D2~ D8 q8h; D9 qd; Drug: FL058 Placebo and Meropenem 2000mg（ IV 180min）; D1 qd; D2~ D8 q8h; D9 qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with adverse events [Safety and Tolerability]	Day 1 to Day 24

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2020
• Primary Completion (Actual): February 24, 2021
• Study Completion (Actual): February 24, 2021

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Meropenem
• Other Study ID Numbers: FL058-I-03

Drug and device information, study documents

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