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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05058105
• Other study ID #: FL058-I-03
• Status: Completed
• Phase: Phase 1
• Start date: October 8, 2020
• Est. completion date: February 24, 2021

Study information

• Verified date: September 2021
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 24, 2021
• Est. primary completion date: February 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• FL058 500mg and Meropenem 1000mg( IV 120min)
D1 qd; D2~ D8 q8h; D9 qd
• FL058 Placebo and Meropenem 1000mg( IV 120min)
D1 qd; D2~ D8 q8h; D9 qd
• FL058 1000mg( IV 120min)
D1 qd;
• FL058 Placebo ( IV 120min)
D1 qd;
• Meropenem 1000 mg ( IV 120min)
D4 qd;
• Meropenem Placebo ( IV 120min)
D4 qd;
• FL058 1000mg and Meropenem 1000mg ( IV 120min)
D7 qd; D8~ D14 q8h; D15 qd;
• FL058 Placebo and Meropenem 1000mg ( IV 120min)
D7 qd; D8~ D14 q8h; D15 qd;
• FL058 1000mg and Meropenem 2000mg ( IV 120min)
D1 qd; D2~ D8 q8h; D9 qd
• FL058 Placebo and Meropenem 2000m( IV 120min)
D1 qd; D2~ D8 q8h; D9 qd
• FL058 1000mg and Meropenem 2000mg ( IV 180min)
D1 qd; D2~ D8 q8h; D9 qd
• FL058 Placebo and Meropenem 2000m( IV 180min)
D1 qd; D2~ D8 q8h; D9 qd
• FL058 2000mg and Meropenem 2000mg( IV 180min)
D1 qd; D2~ D8 q8h; D9 qd
• FL058 Placebo and Meropenem 2000mg( IV 180min)
D1 qd; D2~ D8 q8h; D9 qd

Locations

Country	Name	City	State
China	Huashan Hospital affiliated to Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse events [Safety and Tolerability]		Day 1 to Day 24