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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: FL058 1000mg and Meropenem 2000mg （ IV 120min）; Drug: FL058 1000mg and Meropenem 2000mg （ IV 180min）; Drug: FL058 1000mg（ IV 120min）; Drug: FL058 500mg and Meropenem 1000mg（ IV 120min）; Drug: FL058 2000mg and Meropenem 2000mg（ IV 180min）; Drug: FL058 Placebo and Meropenem 2000m（ IV 180min）; Drug: FL058 Placebo and Meropenem 1000mg（ IV 120min）; Drug: FL058 Placebo （ IV 120min）; Drug: FL058 Placebo and Meropenem 2000m（ IV 120min）; Drug: FL058 Placebo and Meropenem 2000mg（ IV 180min）; 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）

• Registration Number: NCT05058105
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-08
• Primary Completion: 2021-02-24
• Study Completion: 2021-02-24
• Status Verified: 2021-09
• Study First Submitted: 2021-09-08
• Study First Submitted QC: 2021-09-16
• Last Update Submitted: 2021-09-16
• Study First Posted: 2021-09-27
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FL058 1000mg and Meropenem 1000mg	FL058 1000mg and Meropenem 1000mg （ IV 120min）	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)
FL058 1000mg and Meropenem 2000mg (IV 120min)	FL058 1000mg and Meropenem 2000mg （ IV 120min）	FL058 1000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects)
FL058 1000mg and Meropenem 1000mg	Meropenem 1000 mg （ IV 120min）	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)
FL058 1000mg and Meropenem 1000mg	FL058 Placebo and Meropenem 1000mg （ IV 120min）	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)
FL058 1000mg and Meropenem 2000mg (IV 180min)	FL058 1000mg and Meropenem 2000mg （ IV 180min）	FL058 1000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects)
FL058 1000mg and Meropenem 2000mg (IV 180min)	FL058 Placebo and Meropenem 2000m（ IV 180min）	FL058 1000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects)
FL058 500mg and Meropenem 1000mg	FL058 Placebo and Meropenem 1000mg（ IV 120min）	FL058 500mg and Meropenem 1000mg (8 subjects); FL058 Placebo and Meropenem 1000mg(2 subjects)
FL058 1000mg and Meropenem 1000mg	FL058 1000mg（ IV 120min）	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)
FL058 1000mg and Meropenem 1000mg	FL058 Placebo （ IV 120min）	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)
FL058 500mg and Meropenem 1000mg	FL058 500mg and Meropenem 1000mg（ IV 120min）	FL058 500mg and Meropenem 1000mg (8 subjects); FL058 Placebo and Meropenem 1000mg(2 subjects)
FL058 2000mg and Meropenem 2000mg	FL058 2000mg and Meropenem 2000mg（ IV 180min）	FL058 2000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects)
FL058 1000mg and Meropenem 1000mg	Meropenem Placebo （ IV 120min）	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)
FL058 1000mg and Meropenem 2000mg (IV 120min)	FL058 Placebo and Meropenem 2000m（ IV 120min）	FL058 1000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects)
FL058 2000mg and Meropenem 2000mg	FL058 Placebo and Meropenem 2000mg（ IV 180min）	FL058 2000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects)

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events [Safety and Tolerability]	Day 1 to Day 24

Trial Locations

Locations (1)

Huashan Hospital affiliated to Fudan University; 🇨🇳 Shanghai, China