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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* 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）


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults aged between 18 and 45 years (inclusive). Body mass index (BMI) ranges from 19 to 26 kg/m2 (inclusive), and the body weight is ≥50kg. Good general health as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests. 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: Concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological disorders. Positive screen result for HBsAg, HCV-Ab, or HIV-Ab at screening. History of clinically significant food or drug allergy. A QT interval corrected using Fridericia's formula >450 msec. eGFR<90mL/min/1.73m2.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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