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Completed

NCT Number: NCT05058105

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

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Huashan Hospital affiliated to Fudan University

Shanghai, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

D1 qd;

D2~ D8 q8h;

D9 qd

FL058 Placebo and Meropenem 1000mg（ IV 120min）

Drug

D1 qd;

D2~ D8 q8h;

D9 qd

FL058 1000mg（ IV 120min）

Drug

D1 qd;

FL058 Placebo （ IV 120min）

Drug

D1 qd;

Meropenem 1000 mg （ IV 120min）

Drug

D4 qd;

Meropenem Placebo （ IV 120min）

Drug

D4 qd;

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

Drug

D7 qd;

D8~ D14 q8h;

D15 qd;

FL058 Placebo and Meropenem 1000mg （ IV 120min）

Drug

D7 qd;

D8~ D14 q8h;

D15 qd;

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

Drug

D1 qd;

D2~ D8 q8h;

D9 qd

FL058 Placebo and Meropenem 2000m（ IV 120min）

Drug

D1 qd;

D2~ D8 q8h;

D9 qd

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

Drug

D1 qd;

D2~ D8 q8h;

D9 qd

FL058 Placebo and Meropenem 2000m（ IV 180min）

Drug

D1 qd;

D2~ D8 q8h;

D9 qd

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

Drug

D1 qd;

D2~ D8 q8h;

D9 qd

FL058 Placebo and Meropenem 2000mg（ IV 180min）

Drug

D1 qd;

D2~ D8 q8h;

D9 qd

Primary outcomes

  1. Number of patients with adverse events [Safety and Tolerability]

    Time frame: Day 1 to Day 24

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 27, 2021
Registry last updated
Sep 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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