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

Qilu Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: FL058; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05058118

FL058-I-01

Details and patient eligibility

About

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

Enrollment: 54 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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54 participants in 2 patient groups, including a placebo group

FL058

Experimental group

Description:

a single ascending dose (SAD) of intravenous (IV) FL058(50mg\~2000mg)

Treatment:

Drug: FL058

Placebo

Placebo Comparator group

Description:

FL058 Placebo

Treatment:

Drug: Placebo