CompletedNCT05058105Updated Sep 27, 2021

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

A Phase 1 interventional study of FL058 500mg and Meropenem 1000mg（ IV 120min） and FL058 Placebo and Meropenem 1000mg（ IV 120min） in Healthy, sponsored by Qilu Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-27.

Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

Registered 11 months after the study started (first participant enrolled Oct 2020, registered Sep 2021).

Phase: Phase 1
Study type: Interventional
Enrollment: 40
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: All

Study 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.

Conditions studied

Healthy

In context

Lead sponsor

Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 193 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 40 participants (actual)

Study arms

Experimental
FL058 500mg and Meropenem 1000mg
FL058 500mg and Meropenem 1000mg (8 subjects); FL058 Placebo and Meropenem 1000mg(2 subjects)
Drug: FL058 500mg and Meropenem 1000mg（ IV 120min） · Drug: FL058 Placebo and Meropenem 1000mg（ IV 120min）
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)
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）
Experimental
FL058 1000mg and Meropenem 2000mg (IV 120min)
FL058 1000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects)
Drug: FL058 1000mg and Meropenem 2000mg （ IV 120min） · Drug: FL058 Placebo and Meropenem 2000m（ IV 120min）
Experimental
FL058 1000mg and Meropenem 2000mg (IV 180min)
FL058 1000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects)
Drug: FL058 1000mg and Meropenem 2000mg （ IV 180min） · Drug: FL058 Placebo and Meropenem 2000m（ IV 180min）
Experimental
FL058 2000mg and Meropenem 2000mg
FL058 2000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects)
Drug: FL058 2000mg and Meropenem 2000mg（ IV 180min） · Drug: FL058 Placebo and Meropenem 2000mg（ IV 180min）

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

What researchers measure

Primary outcomes

Number of patients with adverse events [Safety and Tolerability]
Time frame: Day 1 to Day 24

Study locations

1 site

Huashan Hospital affiliated to Fudan University
Shanghai, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05058105
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Responsible party: Sponsor
First posted: Sep 27, 2021
Start date: Oct 8, 2020
Primary completion: Feb 24, 2021
Completion: Feb 24, 2021
Last update: Sep 27, 2021

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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