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OpenTrials
Completed

NCT Number: NCT05058118

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

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

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Huashan Hospital affiliated to Fudan University

Shanghai, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adults aged between 18 and 45 years (inclusive).
  • Body mass index (BMI) ranges from 19 to 26 kg/m2 (inclusive), and the body weight is ≥50kg.
  • Good general health as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests.
  • 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

  • Concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological disorders.
  • Positive screen result for HBsAg, HCV-Ab, or HIV-Ab at screening.
  • History of clinically significant food or drug allergy.
  • A QT interval corrected using Fridericia's formula >450 msec.
  • eGFR<90mL/min/1.73m2.

Treatment and study plan

FL058

Drug

50mg、250mg、500mg、1000mg、1500mg、2000mg

Placebo

Drug

empty bottle

Primary outcomes

  1. Number of patients with adverse events [Safety and Tolerability]

    Time frame: Day 1 to Day 7

Secondary outcomes

  1. FL058 -Cmax

    Time frame: Up to 48 hours post-dose

    To evaluate the PK of single intravenous doses of FL058 in healthy adult human subjects.

  2. FL058 -AUC

    Time frame: Up to 48 hours post-dose

    To evaluate the PK of single intravenous doses of FL058 in healthy adult human subjects.

  3. FL058 -t1/2

    Time frame: Up to 48 hours post-dose

    To evaluate the PK of single intravenous doses of FL058 in healthy adult human subjects.

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 27, 2021
Registry last updated
Sep 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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