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

Qilu Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: FL058 Placebo and Meropenem 2000mg（ IV 180min）; Drug: FL058 1000mg and Meropenem 2000mg （ IV 180min）; Drug: FL058 Placebo and Meropenem 1000mg （ IV 120min）; Drug: FL058 500mg and Meropenem 1000mg（ IV 120min）; Drug: FL058 1000mg（ IV 120min）; Drug: Meropenem 1000 mg （ IV 120min）; Drug: FL058 Placebo and Meropenem 2000m（ IV 180min）; Drug: FL058 Placebo （ IV 120min）; Drug: FL058 2000mg and Meropenem 2000mg（ IV 180min）; Drug: FL058 1000mg and Meropenem 1000mg （ IV 120min）; Drug: FL058 Placebo and Meropenem 1000mg（ IV 120min）; Drug: Meropenem Placebo （ IV 120min）; Drug: FL058 1000mg and Meropenem 2000mg （ IV 120min）; Drug: FL058 Placebo and Meropenem 2000m（ IV 120min）

Study type: Interventional

Funder types: Industry

Identifiers

NCT05058105

FL058-I-03

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 5 patient groups

FL058 500mg and Meropenem 1000mg

Experimental group

Description:

FL058 500mg and Meropenem 1000mg (8 subjects); FL058 Placebo and Meropenem 1000mg(2 subjects)

Treatment:

Drug: FL058 500mg and Meropenem 1000mg（ IV 120min）

Drug: FL058 Placebo and Meropenem 1000mg（ IV 120min）

FL058 1000mg and Meropenem 1000mg

Experimental group

Description:

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)

Treatment:

Drug: Meropenem 1000 mg （ IV 120min）

Drug: FL058 Placebo （ IV 120min）

Drug: Meropenem Placebo （ IV 120min）

Drug: FL058 Placebo and Meropenem 1000mg （ IV 120min）

Drug: FL058 1000mg and Meropenem 1000mg （ IV 120min）

Drug: FL058 1000mg（ IV 120min）

FL058 1000mg and Meropenem 2000mg (IV 120min)

Experimental group

Description:

FL058 1000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects)

Treatment:

Drug: FL058 Placebo and Meropenem 2000m（ IV 120min）

Drug: FL058 1000mg and Meropenem 2000mg （ IV 120min）

FL058 1000mg and Meropenem 2000mg (IV 180min)

Experimental group

Description:

FL058 1000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects)

Treatment:

Drug: FL058 1000mg and Meropenem 2000mg （ IV 180min）

Drug: FL058 Placebo and Meropenem 2000m（ IV 180min）

FL058 2000mg and Meropenem 2000mg

Experimental group

Description:

FL058 2000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects)

Treatment:

Drug: FL058 2000mg and Meropenem 2000mg（ IV 180min）

Drug: FL058 Placebo and Meropenem 2000mg（ IV 180min）