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

Sponsor
Qilu Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT05058105
Collaborator
(none)
40
Enrollment
1
Location
5
Arms
4.6
Actual Duration (Months)
8.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: FL058 500mg and Meropenem 1000mg（ IV 120min）
  • Drug: FL058 Placebo and Meropenem 1000mg（ IV 120min）
  • 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）
  • Drug: FL058 1000mg and Meropenem 2000mg （ IV 120min）
  • Drug: FL058 Placebo and Meropenem 2000m（ IV 120min）
  • Drug: FL058 1000mg and Meropenem 2000mg （ IV 180min）
  • Drug: FL058 Placebo and Meropenem 2000m（ IV 180min）
  • Drug: FL058 2000mg and Meropenem 2000mg（ IV 180min）
  • Drug: FL058 Placebo and Meropenem 2000mg（ IV 180min）
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Oct 8, 2020
Actual Primary Completion Date :
Feb 24, 2021
Actual Study Completion Date :
Feb 24, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: FL058 500mg and Meropenem 1000mg

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

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
Experimental: 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)

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

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

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

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

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
Experimental: FL058 2000mg and Meropenem 2000mg

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

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

Outcome Measures

Primary Outcome Measures

  1. Number of patients with adverse events [Safety and Tolerability] [Day 1 to Day 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Huashan Hospital affiliated to Fudan University Shanghai China

Sponsors and Collaborators

  • Qilu Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Qilu Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05058105
Other Study ID Numbers:
  • FL058-I-03
First Posted:
Sep 27, 2021
Last Update Posted:
Sep 27, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Meropenem

Study Results

No Results Posted as of Sep 27, 2021