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

Phase 1

Completed

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

• Registration Number: NCT05058118
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-08
• Primary Completion: 2020-06-03
• Study Completion: 2020-06-03
• 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: 2021-09-27
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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
Placebo	Placebo	FL058 Placebo
FL058	FL058	a single ascending dose (SAD) of intravenous (IV) FL058(50mg\~2000mg)

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events [Safety and Tolerability]	Day 1 to Day 7

Secondary Outcome Measures

Name	Time	Method
FL058 -AUC	Up to 48 hours post-dose	To evaluate the PK of single intravenous doses of FL058 in healthy adult human subjects.
FL058 -Cmax	Up to 48 hours post-dose	To evaluate the PK of single intravenous doses of FL058 in healthy adult human subjects.
FL058 -t1/2	Up to 48 hours post-dose	To evaluate the PK of single intravenous doses of FL058 in healthy adult human subjects.

Trial Locations

Locations (1)

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