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

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

Detailed Description
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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.

Official Title
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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.

Conditions
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Healthy

Intervention / Treatment
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* Drug: FL058
* Drug: Placebo
* Drug: FL058
* Drug: Placebo


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: Part A：FL058<br>a single ascending dose (SAD) of intravenous (IV) FL058(2500mg 3000mg) | Drug: FL058<br>* 2500mg、3000mg<br>|
| Placebo Comparator: Part A：Placebo<br>FL058 Placebo | Drug: Placebo<br>* empty bottle<br>|
| Experimental: Part B：FL058<br>a multiple ascending dose (MAD) of intravenous (IV) FL058(500mg 2000mg) | Drug: FL058<br>* 500mg、1000mg、2000mg<br>|
| Placebo Comparator: Part B：Placebo<br>FL058 Placebo | Drug: Placebo<br>* empty bottle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |