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

Qilu Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: FL058

Study type: Interventional

Funder types: Industry

Identifiers

NCT05055687

FL058-I-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 4 patient groups, including a placebo group

Part A：FL058

Experimental group

Description:

a single ascending dose (SAD) of intravenous (IV) FL058(2500mg\~3000mg)

Treatment:

Drug: FL058

Drug: FL058

Part A：Placebo

Placebo Comparator group

Description:

FL058 Placebo

Treatment:

Drug: Placebo

Drug: Placebo

Part B：FL058

Experimental group

Description:

a multiple ascending dose (MAD) of intravenous (IV) FL058(500mg\~2000mg)

Treatment:

Drug: FL058

Drug: FL058

Part B：Placebo

Placebo Comparator group

Description:

FL058 Placebo

Treatment:

Drug: Placebo

Drug: Placebo