Evaluation of the Safety, Tolerability and Pharmacokinetics of Intravenous FL058 Administered in Healthy Subjects(SAD)
Study Details
Study Description
Brief Summary
To evaluate the safety,tolerability and pharmacokinetics of single intravenous doses of FL058 in healthy Chinese subjects.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: FL058 a single ascending dose (SAD) of intravenous (IV) FL058(50mg~2000mg) |
Drug: FL058
50mg、250mg、500mg、1000mg、1500mg、2000mg
|
Placebo Comparator: Placebo FL058 Placebo |
Drug: Placebo
empty bottle
|
Outcome Measures
Primary Outcome Measures
- Number of patients with adverse events [Safety and Tolerability] [Day 1 to Day 7]
Secondary Outcome Measures
- FL058 -Cmax [Up to 48 hours post-dose]
To evaluate the PK of single intravenous doses of FL058 in healthy adult human subjects.
- FL058 -AUC [Up to 48 hours post-dose]
To evaluate the PK of single intravenous doses of FL058 in healthy adult human subjects.
- FL058 -t1/2 [Up to 48 hours post-dose]
To evaluate the PK of single intravenous doses of FL058 in healthy adult human subjects.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy adults aged between 18 and 45 years (inclusive).
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Body mass index (BMI) ranges from 19 to 26 kg/m2 (inclusive), and the body weight is ≥50kg.
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Good general health as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests.
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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:
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Concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological disorders.
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Positive screen result for HBsAg, HCV-Ab, or HIV-Ab at screening.
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History of clinically significant food or drug allergy.
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A QT interval corrected using Fridericia's formula >450 msec.
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eGFR<90mL/min/1.73m2.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Huashan Hospital affiliated to Fudan University | Shanghai | China |
Sponsors and Collaborators
- Qilu Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FL058-I-01