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

NCT ID: NCT05058105

Last Updated: 2021-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-08

Study Completion Date

2021-02-24

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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FL058 500mg and Meropenem 1000mg

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

FL058 Placebo and Meropenem 1000mg(2 subjects)

Group Type EXPERIMENTAL

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

Intervention Type DRUG

D1 qd;

D2\~ D8 q8h;

D9 qd

FL058 Placebo and Meropenem 1000mg（ IV 120min）

Intervention Type DRUG

D1 qd;

D2\~ D8 q8h;

D9 qd

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)

Group Type EXPERIMENTAL

FL058 1000mg（ IV 120min）

Intervention Type DRUG

D1 qd;

FL058 Placebo （ IV 120min）

Intervention Type DRUG

D1 qd;

Meropenem 1000 mg （ IV 120min）

Intervention Type DRUG

D4 qd;

Meropenem Placebo （ IV 120min）

Intervention Type DRUG

D4 qd;

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

Intervention Type DRUG

D7 qd;

D8\~ D14 q8h;

D15 qd;

FL058 Placebo and Meropenem 1000mg （ IV 120min）

Intervention Type DRUG

D7 qd;

D8\~ D14 q8h;

D15 qd;

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

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

FL058 Placebo and Meropenem 2000mg(2 subjects)

Group Type EXPERIMENTAL

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

Intervention Type DRUG

D1 qd;

D2\~ D8 q8h;

D9 qd

FL058 Placebo and Meropenem 2000m（ IV 120min）

Intervention Type DRUG

D1 qd;

D2\~ D8 q8h;

D9 qd

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

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

FL058 Placebo and Meropenem 2000mg(2 subjects)

Group Type EXPERIMENTAL

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

Intervention Type DRUG

D1 qd;

D2\~ D8 q8h;

D9 qd

FL058 Placebo and Meropenem 2000m（ IV 180min）

Intervention Type DRUG

D1 qd;

D2\~ D8 q8h;

D9 qd

FL058 2000mg and Meropenem 2000mg

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

FL058 Placebo and Meropenem 2000mg(2 subjects)

Group Type EXPERIMENTAL

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

Intervention Type DRUG

D1 qd;

D2\~ D8 q8h;

D9 qd

FL058 Placebo and Meropenem 2000mg（ IV 180min）

Intervention Type DRUG

D1 qd;

D2\~ D8 q8h;

D9 qd

Interventions

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

D1 qd;

D2\~ D8 q8h;

D9 qd

Intervention Type DRUG

FL058 Placebo and Meropenem 1000mg（ IV 120min）

D1 qd;

D2\~ D8 q8h;

D9 qd

Intervention Type DRUG

FL058 1000mg（ IV 120min）

D1 qd;

Intervention Type DRUG

FL058 Placebo （ IV 120min）

D1 qd;

Intervention Type DRUG

Meropenem 1000 mg （ IV 120min）

D4 qd;

Intervention Type DRUG

Meropenem Placebo （ IV 120min）

D4 qd;

Intervention Type DRUG

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

D7 qd;

D8\~ D14 q8h;

D15 qd;

Intervention Type DRUG

FL058 Placebo and Meropenem 1000mg （ IV 120min）

D7 qd;

D8\~ D14 q8h;

D15 qd;

Intervention Type DRUG

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

D1 qd;

D2\~ D8 q8h;

D9 qd

Intervention Type DRUG

FL058 Placebo and Meropenem 2000m（ IV 120min）

D1 qd;

D2\~ D8 q8h;

D9 qd

Intervention Type DRUG

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

D1 qd;

D2\~ D8 q8h;

D9 qd

Intervention Type DRUG

FL058 Placebo and Meropenem 2000m（ IV 180min）

D1 qd;

D2\~ D8 q8h;

D9 qd

Intervention Type DRUG

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

D1 qd;

D2\~ D8 q8h;

D9 qd

Intervention Type DRUG

FL058 Placebo and Meropenem 2000mg（ IV 180min）

D1 qd;

D2\~ D8 q8h;

D9 qd

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Huashan Hospital affiliated to Fudan University

Shanghai, , China

Site Status

Countries

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China

References

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Huang Z, Yang X, Jin Y, Yu J, Cao G, Wang J, Hu Y, Dai J, Wu J, Wei Q, Tian Y, Yu S, Zhu X, Mao X, Liu W, Liang H, Zheng S, Ju Y, Wang Z, Zhang J, Wu X. First-in-human study to evaluate the safety, tolerability, and population pharmacokinetic/pharmacodynamic target attainment analysis of FL058 alone and in combination with meropenem in healthy subjects. Antimicrob Agents Chemother. 2024 Jan 10;68(1):e0133023. doi: 10.1128/aac.01330-23. Epub 2023 Dec 6.

Reference Type DERIVED
PMID: 38054726 (View on PubMed)

Other Identifiers

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FL058-I-03

Identifier Type: -

Identifier Source: org_study_id

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