Healthy
Conditions
Brief summary
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.
Interventions
DRUGFL058 500mg and Meropenem 1000mg（ IV 120min）
D1 qd; D2\ D8 q8h; D9 qd
DRUGFL058 Placebo and Meropenem 1000mg（ IV 120min）
D1 qd; D2\ D8 q8h; D9 qd
DRUGFL058 1000mg（ IV 120min）
D1 qd;
DRUGFL058 Placebo （ IV 120min）
D1 qd;
DRUGMeropenem 1000 mg （ IV 120min）
D4 qd;
DRUGMeropenem Placebo （ IV 120min）
D4 qd;
DRUGFL058 1000mg and Meropenem 1000mg （ IV 120min）
D7 qd; D8\ D14 q8h; D15 qd;
DRUGFL058 Placebo and Meropenem 1000mg （ IV 120min）
D7 qd; D8\ D14 q8h; D15 qd;
DRUGFL058 1000mg and Meropenem 2000mg （ IV 120min）
D1 qd; D2\ D8 q8h; D9 qd
DRUGFL058 Placebo and Meropenem 2000m（ IV 120min）
D1 qd; D2\ D8 q8h; D9 qd
DRUGFL058 1000mg and Meropenem 2000mg （ IV 180min）
D1 qd; D2\ D8 q8h; D9 qd
DRUGFL058 Placebo and Meropenem 2000m（ IV 180min）
D1 qd; D2\ D8 q8h; D9 qd
DRUGFL058 2000mg and Meropenem 2000mg（ IV 180min）
D1 qd; D2\ D8 q8h; D9 qd
DRUGFL058 Placebo and Meropenem 2000mg（ IV 180min）
D1 qd; D2\ D8 q8h; D9 qd
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adults aged between 18 and 45 years (inclusive). 2. Body mass index (BMI) ranges from 19 to 26 kg/m2 (inclusive), and the body weight is ≥50kg. 3. Good general health as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests. 4. 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
1. Concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological disorders. 2. Positive screen result for HBsAg, HCV-Ab, or HIV-Ab at screening. 3. History of clinically significant food or drug allergy. 4. A QT interval corrected using Fridericia's formula \>450 msec. 5. eGFR\<90mL/min/1.73m2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with adverse events [Safety and Tolerability] | Day 1 to Day 24 |
Countries
China
Outcome results
None listed