HealthyPhase 1NCT05058105

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

A Phase 1 study testing FL058 500mg and Meropenem 1000mg（ IV 120min）, FL058 1000mg（ IV 120min） and Meropenem 1000 mg （ IV 120min） in people with Healthy, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of FL058 and Meropenem Alone and in Combination following Single and Multiple Doses in Healthy Adult Subjects. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: FL058 500mg and Meropenem 1000mg（ IV 120min）, FL058 1000mg（ IV 120min） and Meropenem 1000 mg （ IV 120min）
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteChina
Study dates: 8 Oct 2020to 24 Feb 2021
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Huashan Hospital affiliated to Fudan University
Shanghai

Other trials in China

About this study

Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple Ascending-dose Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous FL058 and Meropenem Alone and in Combination in Healthy Chinese Subjects

Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of FL058 and Meropenem Alone and in Combination following Single and Multiple Doses in Healthy Adult Subjects.

Conditions: Healthy
Being tested: FL058 500mg and Meropenem 1000mg（ IV 120min）, FL058 Placebo and Meropenem 1000mg（ IV 120min）, FL058 1000mg（ IV 120min）, FL058 Placebo （ IV 120min）, Meropenem 1000 mg （ IV 120min）

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FL058 500mg and Meropenem 1000mg（ IV 120min）Drug
D1 qd;
D2~ D8 q8h;
D9 qd
FL058 Placebo and Meropenem 1000mg（ IV 120min）Drug
D1 qd;
D2~ D8 q8h;
D9 qd
FL058 1000mg（ IV 120min）Drug
D1 qd;
FL058 Placebo （ IV 120min）Drug
D1 qd;
Meropenem 1000 mg （ IV 120min）Drug
D4 qd;
Meropenem Placebo （ IV 120min）Drug
D4 qd;
FL058 1000mg and Meropenem 1000mg （ IV 120min）Drug
D7 qd;
D8~ D14 q8h;
D15 qd;
FL058 Placebo and Meropenem 1000mg （ IV 120min）Drug
D7 qd;
D8~ D14 q8h;
D15 qd;
FL058 1000mg and Meropenem 2000mg （ IV 120min）Drug
D1 qd;
D2~ D8 q8h;
D9 qd
FL058 Placebo and Meropenem 2000m（ IV 120min）Drug
D1 qd;
D2~ D8 q8h;
D9 qd
FL058 1000mg and Meropenem 2000mg （ IV 180min）Drug
D1 qd;
D2~ D8 q8h;
D9 qd
FL058 Placebo and Meropenem 2000m（ IV 180min）Drug
D1 qd;
D2~ D8 q8h;
D9 qd
FL058 2000mg and Meropenem 2000mg（ IV 180min）Drug
D1 qd;
D2~ D8 q8h;
D9 qd
FL058 Placebo and Meropenem 2000mg（ IV 180min）Drug
D1 qd;
D2~ D8 q8h;
D9 qd

Study groups in NCT05058105
Study group	Role	What they receive
FL058 500mg and Meropenem 1000mg	Experimental	FL058 500mg and Meropenem 1000mg (8 subjects); FL058 Placebo and Meropenem 1000mg(2 subjects) Receives: Drug: FL058 500mg and Meropenem 1000mg（ IV 120min）; Drug: FL058 Placebo and Meropenem 1000mg（ IV 120min）
FL058 1000mg and Meropenem 1000mg	Experimental	D1 FL058 1000mg(8 subjects) and FL058 Placebo(2 subjects); D4 Meropenem 1000mg(8 subjects) and Meropenem Placebo(2 subjects); D7~ D15 FL058 1000mg and Meropenem 1000mg (8 subjects); FL058 Placebo and Meropenem 1000mg(2 subjects) Receives: Drug: FL058 1000mg（ IV 120min）; Drug: FL058 Placebo （ IV 120min）; Drug: Meropenem 1000 mg （ IV 120min）; Drug: Meropenem Placebo （ IV 120min）; Drug: FL058 1000mg and Meropenem 1000mg （ IV 120min）; Drug: FL058 Placebo and Meropenem 1000mg （ IV 120min）
FL058 1000mg and Meropenem 2000mg (IV 120min)	Experimental	FL058 1000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects) Receives: Drug: FL058 1000mg and Meropenem 2000mg （ IV 120min）; Drug: FL058 Placebo and Meropenem 2000m（ IV 120min）
FL058 1000mg and Meropenem 2000mg (IV 180min)	Experimental	FL058 1000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects) Receives: Drug: FL058 1000mg and Meropenem 2000mg （ IV 180min）; Drug: FL058 Placebo and Meropenem 2000m（ IV 180min）
FL058 2000mg and Meropenem 2000mg	Experimental	FL058 2000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects) Receives: Drug: FL058 2000mg and Meropenem 2000mg（ IV 180min）; Drug: FL058 Placebo and Meropenem 2000mg（ IV 180min）

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of patients with adverse events [Safety and Tolerability]
Measured: Day 1 to Day 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 202024 Feb 2021

First posted27 Sep 2021
Study start8 Oct 2020
Primary completion24 Feb 2021
Study completion24 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05058105
Sponsor's protocol ID: FL058-I-03
Status last verified: Sep 2021
First submitted: 8 Sep 2021
Last updated: 27 Sep 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Huang Z, Yang X, Jin Y, Yu J, Cao G, Wang J, Hu Y, Dai J, Wu J, Wei Q, Tian Y, Yu S, Zhu X, Mao X, Liu W, Liang H, Zheng S, Ju Y, Wang Z, Zhang J, Wu X. First-in-human study to evaluate the safety, tolerability, and population pharmacokinetic/pharmacodynamic target attainment analysis of FL058 alone and in combination with meropenem in healthy subjects. Antimicrob Agents Chemother. 2024 Jan 10;68(1):e0133023. doi: 10.1128/aac.01330-23. Epub 2023 Dec 6.
PubMed 38054726

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple Ascending-dose Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous FL058 and Meropenem Alone and in Combination in Healthy Chinese Subjects
ClinicalTrials.gov ID: NCT05058105
Acronym / sponsor ID: FL058-I-03
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 8 Oct 2020 (actual)
Primary completion: 24 Feb 2021 (actual)
Study completion: 24 Feb 2021 (actual)
First posted: 27 Sep 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of FL058 and Meropenem Alone and in Combination following Single and Multiple Doses in Healthy Adult Subjects.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
FL058 500mg and Meropenem 1000mg	Experimental	Drug: FL058 500mg and Meropenem 1000mg（ IV 120min）, Drug: FL058 Placebo and Meropenem 1000mg（ IV 120min）FL058 500mg and Meropenem 1000mg (8 subjects); FL058 Placebo and Meropenem 1000mg(2 subjects)
FL058 1000mg and Meropenem 1000mg	Experimental	Drug: FL058 1000mg（ IV 120min）, Drug: FL058 Placebo （ IV 120min）, Drug: Meropenem 1000 mg （ IV 120min）, Drug: Meropenem Placebo （ IV 120min）, Drug: FL058 1000mg and Meropenem 1000mg （ IV 120min）, Drug: FL058 Placebo and Meropenem 1000mg （ IV 120min）D1 FL058 1000mg(8 subjects) and FL058 Placebo(2 subjects); D4 Meropenem 1000mg(8 subjects) and Meropenem Placebo(2 subjects); D7~ D15 FL058 1000mg and Meropenem 1000mg (8 subjects); FL058 Placebo and Meropenem 1000mg(2 subjects)
FL058 1000mg and Meropenem 2000mg (IV 120min)	Experimental	Drug: FL058 1000mg and Meropenem 2000mg （ IV 120min）, Drug: FL058 Placebo and Meropenem 2000m（ IV 120min）FL058 1000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects)
FL058 1000mg and Meropenem 2000mg (IV 180min)	Experimental	Drug: FL058 1000mg and Meropenem 2000mg （ IV 180min）, Drug: FL058 Placebo and Meropenem 2000m（ IV 180min）FL058 1000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects)
FL058 2000mg and Meropenem 2000mg	Experimental	Drug: FL058 2000mg and Meropenem 2000mg（ IV 180min）, Drug: FL058 Placebo and Meropenem 2000mg（ IV 180min）FL058 2000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects)

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FL058 500mg and Meropenem 1000mg（ IV 120min）D1 qd; D2~ D8 q8h; D9 qd	Drug	FL058 500mg and Meropenem 1000mg
FL058 Placebo and Meropenem 1000mg（ IV 120min）D1 qd; D2~ D8 q8h; D9 qd	Drug	FL058 500mg and Meropenem 1000mg
FL058 1000mg（ IV 120min）D1 qd;	Drug	FL058 1000mg and Meropenem 1000mg
FL058 Placebo （ IV 120min）D1 qd;	Drug	FL058 1000mg and Meropenem 1000mg
Meropenem 1000 mg （ IV 120min）D4 qd;	Drug	FL058 1000mg and Meropenem 1000mg
Meropenem Placebo （ IV 120min）D4 qd;	Drug	FL058 1000mg and Meropenem 1000mg
FL058 1000mg and Meropenem 1000mg （ IV 120min）D7 qd; D8~ D14 q8h; D15 qd;	Drug	FL058 1000mg and Meropenem 1000mg
FL058 Placebo and Meropenem 1000mg （ IV 120min）D7 qd; D8~ D14 q8h; D15 qd;	Drug	FL058 1000mg and Meropenem 1000mg
FL058 1000mg and Meropenem 2000mg （ IV 120min）D1 qd; D2~ D8 q8h; D9 qd	Drug	FL058 1000mg and Meropenem 2000mg (IV 120min)
FL058 Placebo and Meropenem 2000m（ IV 120min）D1 qd; D2~ D8 q8h; D9 qd	Drug	FL058 1000mg and Meropenem 2000mg (IV 120min)
FL058 1000mg and Meropenem 2000mg （ IV 180min）D1 qd; D2~ D8 q8h; D9 qd	Drug	FL058 1000mg and Meropenem 2000mg (IV 180min)
FL058 Placebo and Meropenem 2000m（ IV 180min）D1 qd; D2~ D8 q8h; D9 qd	Drug	FL058 1000mg and Meropenem 2000mg (IV 180min)
FL058 2000mg and Meropenem 2000mg（ IV 180min）D1 qd; D2~ D8 q8h; D9 qd	Drug	FL058 2000mg and Meropenem 2000mg
FL058 Placebo and Meropenem 2000mg（ IV 180min）D1 qd; D2~ D8 q8h; D9 qd	Drug	FL058 2000mg and Meropenem 2000mg

Primary outcome

Number of patients with adverse events [Safety and Tolerability]
Time frame: Day 1 to Day 24

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
Derived from this study: PubMed 38054726Huang Z, Yang X, Jin Y, Yu J, Cao G, Wang J, Hu Y, Dai J, Wu J, Wei Q, Tian Y, Yu S, Zhu X, Mao X, Liu W, Liang H, Zheng S, Ju Y, Wang Z, Zhang J, Wu X. First-in-human study to evaluate the safety, tolerability, and population pharmacokinetic/pharmacodynamic target attainment analysis of FL058 alone and in combination with meropenem in healthy subjects. Antimicrob Agents Chemother. 2024 Jan 10;68(1):e0133023. doi: 10.1128/aac.01330-23. Epub 2023 Dec 6.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with adverse events [Safety and Tolerability] (time frame: Day 1 to Day 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05058105, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.