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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: FL058; Drug: Placebo

• Registration Number: NCT05055687
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief Summary

To evaluate the safety,tolerability and pharmacokinetics of single-multiple intravenous doses of FL058 in healthy Chinese subjects.

Detailed Description

This study is divided into two parts: A and B.Part A discusses the safety and tolerability of IV FL058 single ascending dose (SAD) in two cohorts. Part B discusses the safety and tolerability of intravenous injection of FL058 in multiple dose (MAD) in three cohorts.

Study Timeline

• Study Start: 2020-07-05
• Primary Completion: 2020-07-27
• Study Completion: 2020-07-27
• Status Verified: 2021-09
• Study First Submitted: 2021-09-08
• Study First Submitted QC: 2021-09-16
• Last Update Submitted: 2021-09-16
• Study First Posted: 2021-09-24
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part B：FL058	FL058	a multiple ascending dose (MAD) of intravenous (IV) FL058(500mg\~2000mg)
Part A：FL058	FL058	a single ascending dose (SAD) of intravenous (IV) FL058(2500mg\~3000mg)
Part A：Placebo	Placebo	FL058 Placebo
Part B：Placebo	Placebo	FL058 Placebo

Primary Outcome Measures

Name	Time	Method
Part B:Number of patients with adverse events [Safety and Tolerability]	Day 1 to Day 12
Part A:Number of patients with adverse events [Safety and Tolerability]	Day 1 to Day 7

Trial Locations

Locations (1)

Huashan Hospital affiliated to Fudan University; 🇨🇳 Shanghai, China