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

• Status: Completed
• Trial end date: 2021-02-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.
• Treatments: Meropenem

Criteria

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.