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

Healthy Clinical Trial

Official title:

A Randomized, Double-Blind, Single-Dose, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of FL058 for Injection in Healthy Chinese Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05058118
• Other study ID #: FL058-I-01
• Status: Completed
• Phase: Phase 1
• Start date: December 8, 2019
• Est. completion date: June 3, 2020

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 3, 2020
• Est. primary completion date: June 3, 2020
• 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
50mg?250mg?500mg?1000mg?1500mg?2000mg
• Placebo
empty bottle

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 7
Secondary	FL058 -Cmax	To evaluate the PK of single intravenous doses of FL058 in healthy adult human subjects.	Up to 48 hours post-dose
Secondary	FL058 -AUC	To evaluate the PK of single intravenous doses of FL058 in healthy adult human subjects.	Up to 48 hours post-dose
Secondary	FL058 -t1/2	To evaluate the PK of single intravenous doses of FL058 in healthy adult human subjects.	Up to 48 hours post-dose