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

A Randomized, Double-Blind, Single- Multiple 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

NCT05055687

Enrollment

Registered

2021-09-24

Start date

2020-07-05

Completion date

2020-07-27

Last updated

2021-09-24

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-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.

Interventions

DRUGFL058

2500mg、3000mg

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

Countries

China

Outcome results

None listed

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