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

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

• Healthy

Interventions

DRUG

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

D1 qd; D2\~ D8 q8h; D9 qd

DRUG

FL058 Placebo and Meropenem 1000mg（ IV 120min）

D1 qd; D2\~ D8 q8h; D9 qd

DRUG

FL058 1000mg（ IV 120min）

D1 qd;

DRUG

FL058 Placebo （ IV 120min）

D1 qd;

DRUG

Meropenem 1000 mg （ IV 120min）

D4 qd;

DRUG

Meropenem Placebo （ IV 120min）

D4 qd;

DRUG

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

D7 qd; D8\~ D14 q8h; D15 qd;

DRUG

FL058 Placebo and Meropenem 1000mg （ IV 120min）

D7 qd; D8\~ D14 q8h; D15 qd;

DRUG

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

D1 qd; D2\~ D8 q8h; D9 qd

DRUG

FL058 Placebo and Meropenem 2000m（ IV 120min）

D1 qd; D2\~ D8 q8h; D9 qd

DRUG

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

D1 qd; D2\~ D8 q8h; D9 qd

DRUG

FL058 Placebo and Meropenem 2000m（ IV 180min）

D1 qd; D2\~ D8 q8h; D9 qd

DRUG

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

D1 qd; D2\~ D8 q8h; D9 qd

DRUG

FL058 Placebo and Meropenem 2000mg（ IV 180min）

D1 qd; D2\~ D8 q8h; D9 qd

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-10-08

Primary Completion

2021-02-24

Completion

2021-02-24

Countries

• China

Study Locations