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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-05

Study Completion Date

2020-07-27

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part A：FL058

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

Group Type EXPERIMENTAL

FL058

Intervention Type DRUG

2500mg、3000mg

Part A：Placebo

FL058 Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

empty bottle

Part B：FL058

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

Group Type EXPERIMENTAL

FL058

Intervention Type DRUG

500mg、1000mg、2000mg

Part B：Placebo

FL058 Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

empty bottle

Interventions

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FL058

2500mg、3000mg

Intervention Type DRUG

Placebo

empty bottle

Intervention Type DRUG

FL058

500mg、1000mg、2000mg

Intervention Type DRUG

Placebo

empty bottle

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes