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

• Sponsor: Qilu Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05055687
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 4
• Actual Duration (Days): 22
• Patients Per Site Per Month: 27.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: FL058; Drug: Placebo; Drug: FL058; Drug: Placebo	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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.
• Actual Study Start Date: Jul 5, 2020
• Actual Primary Completion Date: Jul 27, 2020
• Actual Study Completion Date: Jul 27, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A：FL058 a single ascending dose (SAD) of intravenous (IV) FL058(2500mg~3000mg)	Drug: FL058; 2500mg、3000mg
Placebo Comparator: Part A：Placebo FL058 Placebo	Drug: Placebo; empty bottle
Experimental: Part B：FL058 a multiple ascending dose (MAD) of intravenous (IV) FL058(500mg~2000mg)	Drug: FL058; 500mg、1000mg、2000mg
Placebo Comparator: Part B：Placebo FL058 Placebo	Drug: Placebo; empty bottle

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Huashan Hospital affiliated to Fudan University	Shanghai		China

Sponsors and Collaborators

• Qilu Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Qilu Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05055687
• Other Study ID Numbers: FL058-I-02
• First Posted: Sep 24, 2021
• Last Update Posted: Sep 24, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 24, 2021