Safety, Tolerability, Pharmacokinetics of Intravenous FL058 and Meropenem in Healthy Subjects(SAD/MAD)
September 16, 2021 updated by: Qilu Pharmaceutical Co., Ltd.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- 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）
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Shanghai, China
- Huashan Hospital affiliated to Fudan University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: FL058 500mg and Meropenem 1000mg
FL058 500mg and Meropenem 1000mg (8 subjects); FL058 Placebo and Meropenem 1000mg(2 subjects) |
D1 qd; D2~ D8 q8h; D9 qd D1 qd; D2~ D8 q8h; D9 qd |
|
Experimental: FL058 1000mg and Meropenem 1000mg
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) |
D1 qd;
D1 qd;
D4 qd;
D4 qd;
D7 qd; D8~ D14 q8h; D15 qd; D7 qd; D8~ D14 q8h; D15 qd; |
|
Experimental: FL058 1000mg and Meropenem 2000mg (IV 120min)
FL058 1000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects) |
D1 qd; D2~ D8 q8h; D9 qd D1 qd; D2~ D8 q8h; D9 qd |
|
Experimental: FL058 1000mg and Meropenem 2000mg (IV 180min)
FL058 1000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects) |
D1 qd; D2~ D8 q8h; D9 qd D1 qd; D2~ D8 q8h; D9 qd |
|
Experimental: FL058 2000mg and Meropenem 2000mg
FL058 2000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects) |
D1 qd; D2~ D8 q8h; D9 qd D1 qd; D2~ D8 q8h; D9 qd |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of patients with adverse events [Safety and Tolerability]
Time Frame: Day 1 to Day 24
|
Day 1 to Day 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 8, 2020
Primary Completion (Actual)
February 24, 2021
Study Completion (Actual)
February 24, 2021
Study Registration Dates
First Submitted
September 8, 2021
First Submitted That Met QC Criteria
September 16, 2021
First Posted (Actual)
September 27, 2021
Study Record Updates
Last Update Posted (Actual)
September 27, 2021
Last Update Submitted That Met QC Criteria
September 16, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FL058-I-03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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