Evaluation of the Safety, Tolerability and Pharmacokinetics of Intravenous FL058 Administered in Healthy Subjects(SAD/MAD)
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.
1 other identifier
interventional
20
1 country
1
Brief Summary
To evaluate the safety,tolerability and pharmacokinetics of single-multiple intravenous doses of FL058 in healthy Chinese subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Jul 2020
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2020
CompletedFirst Submitted
Initial submission to the registry
September 8, 2021
CompletedFirst Posted
Study publicly available on registry
September 24, 2021
CompletedSeptember 24, 2021
September 1, 2021
22 days
September 8, 2021
September 16, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (4)
Part A：FL058
EXPERIMENTALa single ascending dose (SAD) of intravenous (IV) FL058(2500mg\~3000mg)
Part A：Placebo
PLACEBO COMPARATORFL058 Placebo
Part B：FL058
EXPERIMENTALa multiple ascending dose (MAD) of intravenous (IV) FL058(500mg\~2000mg)
Part B：Placebo
PLACEBO COMPARATORFL058 Placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Huashan Hospital affiliated to Fudan University
Shanghai, China
Related Publications (1)
Huang Z, Yang X, Jin Y, Yu J, Cao G, Wang J, Hu Y, Dai J, Wu J, Wei Q, Tian Y, Yu S, Zhu X, Mao X, Liu W, Liang H, Zheng S, Ju Y, Wang Z, Zhang J, Wu X. First-in-human study to evaluate the safety, tolerability, and population pharmacokinetic/pharmacodynamic target attainment analysis of FL058 alone and in combination with meropenem in healthy subjects. Antimicrob Agents Chemother. 2024 Jan 10;68(1):e0133023. doi: 10.1128/aac.01330-23. Epub 2023 Dec 6.
PMID: 38054726DERIVED
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2021
First Posted
September 24, 2021
Study Start
July 5, 2020
Primary Completion
July 27, 2020
Study Completion
July 27, 2020
Last Updated
September 24, 2021
Record last verified: 2021-09