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

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05058118

Enrollment

Registered

2021-09-27

Start date

2019-12-08

Completion date

2020-06-03

Last updated

2021-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

DRUGFL058

50mg、250mg、500mg、1000mg、1500mg、2000mg

DRUGPlacebo

empty bottle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
FL058 -Cmax	Up to 48 hours post-dose	To evaluate the PK of single intravenous doses of FL058 in healthy adult human subjects.
FL058 -AUC	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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026