NCT05058105

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Oct 2020

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 27, 2021

Completed
Last Updated

September 27, 2021

Status Verified

September 1, 2021

Enrollment Period

5 months

First QC Date

September 8, 2021

Last Update Submit

September 16, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Number of patients with adverse events [Safety and Tolerability]

    Day 1 to Day 24

Study Arms (5)

FL058 500mg and Meropenem 1000mg

EXPERIMENTAL

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）

FL058 1000mg and Meropenem 1000mg

EXPERIMENTAL

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）

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

EXPERIMENTAL

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）

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

EXPERIMENTAL

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）

FL058 2000mg and Meropenem 2000mg

EXPERIMENTAL

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

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

D1 qd; D2\~ D8 q8h; D9 qd

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

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

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

D1 qd;

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

D1 qd;

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

D4 qd;

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

D4 qd;

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

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

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

D1 qd; D2\~ D8 q8h; D9 qd

FL058 1000mg and Meropenem 2000mg (IV 120min)
FL058 Placebo and Meropenem 2000m（ IV 120min）DRUG

D1 qd; D2\~ D8 q8h; D9 qd

FL058 1000mg and Meropenem 2000mg (IV 120min)
FL058 1000mg and Meropenem 2000mg （ IV 180min）DRUG

D1 qd; D2\~ D8 q8h; D9 qd

FL058 1000mg and Meropenem 2000mg (IV 180min)
FL058 Placebo and Meropenem 2000m（ IV 180min）DRUG

D1 qd; D2\~ D8 q8h; D9 qd

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

D1 qd; D2\~ D8 q8h; D9 qd

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

D1 qd; D2\~ D8 q8h; D9 qd

FL058 2000mg and Meropenem 2000mg

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital affiliated to Fudan University

Shanghai, China

Location

Related Publications (1)

  • 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.

    PMID: 38054726DERIVED

MeSH Terms

Interventions

Meropenem

Intervention Hierarchy (Ancestors)

ThienamycinsCarbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2021

First Posted

September 27, 2021

Study Start

October 8, 2020

Primary Completion

February 24, 2021

Study Completion

February 24, 2021

Last Updated

September 27, 2021

Record last verified: 2021-09

Locations

CN(1)