HealthyPhase 1NCT05862974

A Dose-escalation Study of LPM3480392 in Chinese Healthy Subjects

A Phase 1 study testing LPM3480392 in people with Healthy, run by Luye Pharma Group Ltd. at 1 site in China.

Completed

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

Trial summary

This is a randomized, double-blind, placebo-controlled, dose-increasing Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single intravenous infusion of LPM3480392 injection in healthy subject Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: LPM3480392
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteChina
Study dates: 25 Feb 2021to 2 Nov 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
Men only
Healthy volunteers accepted
Adult

Who may be able to join

The subject voluntarily signs the informed consent;
Healthy male, aged 18-45 years (including boundary values);
Body mass index (BMI) 19-26kg/m2 (including boundary value), weight ≥50kg;
Subjects are willing to take contraceptive measures and promise not to donate sperm during the study period and within 90 days after administration;
Willing to accept cold pain test, and the non-dominant hand can be soaked in ice water bath at 2℃ (± 0.2℃) for > 10s, < 120s.

Who cannot join

Known history of allergy to any component of the investigational product or similar drugs, or allergic constitution [subjects with previous allergy to two or more foods or drugs];
Past or present with any clinically significant disease or chronic disease of the respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, hematology, psychiatry, dermatology, orthostatic hypotension, etc.; or any disease that may interfere with the test results or interpretation of the results;
Patients with Raynaud's syndrome;
The skin wounds or skin diseases that may affect the cold pain test results; Sitting systolic blood pressure (SBP) < 90 mmHg, ≥ 140 mmHg or diastolic blood pressure (DBP) < 60 mmHg, ≥ 90 mmHg; subjects with heart rate < 60 beats/min, > 100 beats/min;
QTc > 450 ms on electrocardiogram;
Positive urine nicotine test;

Show all 9Show fewer

History of alcohol abuse within 3 months prior to Screening, defined as consumption of more than 14 units of alcohol per week (1 unit = 360 mL of beer, or 45 mL of spirits of 40% alcohol content, or 150 mL of wine), or a positive breath alcohol result;
History of drug abuse or drug abuse or positive result of urine drug screening;
Those who consume more than 100 g of xanthine-rich foods such as chocolate per day on average; those who consume more than 100 g of foods containing grapefruit and/or pomelo; those who consume more than 1000 mL of strong tea, coffee, cola and beverages containing caffeine and/or grapefruit ingredients.

Trial locations and contacts

1 site in 1 country.

China1 site

The second affiliated hosipital zhejiang university school of medicine
Hangzhou, Zhejiang, 310000

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Dose-increasing Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Intravenous Infusion of LPM3480392 Injection in Healthy Subject

Read the detailed description

A total of 80 healthy subjects will be allocated to 1 of 8 cohorts (cohort 1~8) in the study, each cohort including 10 subjects (8 subjects will receive investigational new drug (IND) product and 2 receive placebo). Each subject in fasted state will be randomly assigned to receive a single dose of LPM3480392 or placebo intravenously.

Conditions: Healthy
Being tested: LPM3480392, Placebo

What participants receive

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

LPM3480392Drug
Intravenous infusion of 30min duration
PlaceboDrug
Intravenous infusion of 30min duration

Study groups in NCT05862974
Study group	Role	What they receive
LPM3480392 X1mg	Experimental	8 subjects will receive LPM3480392 X1mg and 2 receive placebo Receives: Drug: LPM3480392; Drug: Placebo
LPM3480392 X2mg	Experimental	8 subjects will receive LPM3480392 X2 mg and 2 receive placebo Receives: Drug: LPM3480392; Drug: Placebo
LPM3480392 X3mg	Experimental	8 subjects will receive LPM3480392 X3mg and 2 receive placebo Receives: Drug: LPM3480392; Drug: Placebo
LPM3480392 X4mg	Experimental	8 subjects will receive LPM3480392 X4mg and 2 receive placebo Receives: Drug: LPM3480392; Drug: Placebo
LPM3480392 X5mg	Experimental	8 subjects will receive LPM3480392 X5mg and 2 receive placebo Receives: Drug: LPM3480392; Drug: Placebo
LPM3480392 X6mg	Experimental	8 subjects will receive LPM3480392 X6mg and 2 receive placebo Receives: Drug: LPM3480392; Drug: Placebo
LPM3480392 X7mg	Experimental	8 subjects will receive LPM3480392 X7mg and 2 receive placebo Receives: Drug: LPM3480392; Drug: Placebo
LPM3480392 X8mg	Experimental	8 subjects will receive LPM3480392 X8mg and 2 receive placebo Receives: Drug: LPM3480392; Drug: Placebo

What is being measured

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

Incidents of AE (including SAE)
(including abnormal value of Vital signs,physical examination,laboratory tests,12-lead ECG)
Measured: from baseline to day8
DEQ
Drug effect questionnaire,
Measured: from baseline to day2
OWS
Opiate Withdrawal Scale
Measured: from baseline to day3

Secondary outcomes (11)

AUC0-t
Pharmacokinetic index
Measured: baseline and 48 hours after administration
AUC0-∞
Pharmacokinetic index
Measured: baseline and 48 hours after administration
Cmax
Pharmacokinetic index
Measured: baseline and 48 hours after administration
Tmax
Pharmacokinetic index
Measured: baseline and 48 hours after administration
T1/2
Pharmacokinetic index
Measured: baseline and 48 hours after administration
CL
Pharmacokinetic index
Measured: baseline and 48 hours after administration
Vd
Pharmacokinetic index
Measured: baseline and 48 hours after administration
MRT
Pharmacokinetic index
Measured: baseline and 48 hours after administration
λz
Pharmacokinetic index
Measured: baseline and 48 hours after administration
PD profile : Cold Pain Test
Pharmacodynamic index
Measured: baseline and 8 hours after administration
PD profile : Pupillometry
Pharmacodynamic index
Measured: baseline and 8 hours after administration

Timeline

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

25 Feb 20212 Nov 2021

First posted17 May 2023
Study start25 Feb 2021
Primary completion2 Nov 2021
Study completion2 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Luye Pharma Group 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: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05862974
Sponsor's protocol ID: LY03014/CT-CHN-101
Status last verified: May 2023
First submitted: 6 Dec 2021
Last updated: 17 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

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 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Dose-increasing Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Intravenous Infusion of LPM3480392 Injection in Healthy Subject
ClinicalTrials.gov ID: NCT05862974
Acronym / sponsor ID: LY03014/CT-CHN-101
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
Study start: 25 Feb 2021 (actual)
Primary completion: 2 Nov 2021 (actual)
Study completion: 2 Nov 2021 (actual)
First posted: 17 May 2023 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
LPM3480392 X1mg	Experimental	Drug: LPM3480392, Drug: Placebo8 subjects will receive LPM3480392 X1mg and 2 receive placebo
LPM3480392 X2mg	Experimental	Drug: LPM3480392, Drug: Placebo8 subjects will receive LPM3480392 X2 mg and 2 receive placebo
LPM3480392 X3mg	Experimental	Drug: LPM3480392, Drug: Placebo8 subjects will receive LPM3480392 X3mg and 2 receive placebo
LPM3480392 X4mg	Experimental	Drug: LPM3480392, Drug: Placebo8 subjects will receive LPM3480392 X4mg and 2 receive placebo
LPM3480392 X5mg	Experimental	Drug: LPM3480392, Drug: Placebo8 subjects will receive LPM3480392 X5mg and 2 receive placebo
LPM3480392 X6mg	Experimental	Drug: LPM3480392, Drug: Placebo8 subjects will receive LPM3480392 X6mg and 2 receive placebo
LPM3480392 X7mg	Experimental	Drug: LPM3480392, Drug: Placebo8 subjects will receive LPM3480392 X7mg and 2 receive placebo
LPM3480392 X8mg	Experimental	Drug: LPM3480392, Drug: Placebo8 subjects will receive LPM3480392 X8mg and 2 receive placebo

Who may qualify

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

Key inclusion criteria (5 listed)

The subject voluntarily signs the informed consent;
Healthy male, aged 18-45 years (including boundary values);
Body mass index (BMI) 19-26kg/m2 (including boundary value), weight ≥50kg;
Subjects are willing to take contraceptive measures and promise not to donate sperm during the study period and within 90 days after administration;
Willing to accept cold pain test, and the non-dominant hand can be soaked in ice water bath at 2℃ (± 0.2℃) for > 10s, < 120s.

Key exclusion criteria (9 listed)

Known history of allergy to any component of the investigational product or similar drugs, or allergic constitution [subjects with previous allergy to two or more foods or drugs];
Past or present with any clinically significant disease or chronic disease of the respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, hematology, psychiatry, dermatology, orthostatic hypotension, etc.; or any disease that may interfere with the test results or interpretation of the results;
Patients with Raynaud's syndrome;
The skin wounds or skin diseases that may affect the cold pain test results; Sitting systolic blood pressure (SBP) < 90 mmHg, ≥ 140 mmHg or diastolic blood pressure (DBP) < 60 mmHg, ≥ 90 mmHg; subjects with heart rate < 60 beats/min, > 100 beats/min;
QTc > 450 ms on electrocardiogram;

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
LPM3480392Intravenous infusion of 30min duration	Drug	LPM3480392 X1mg, LPM3480392 X2mg, LPM3480392 X3mg, LPM3480392 X4mg, LPM3480392 X5mg, LPM3480392 X6mg, LPM3480392 X7mg, LPM3480392 X8mg
PlaceboIntravenous infusion of 30min duration	Drug	LPM3480392 X1mg, LPM3480392 X2mg, LPM3480392 X3mg, LPM3480392 X4mg, LPM3480392 X5mg, LPM3480392 X6mg, LPM3480392 X7mg, LPM3480392 X8mg

Primary outcome

Incidents of AE (including SAE)
Time frame: from baseline to day8
(including abnormal value of Vital signs,physical examination,laboratory tests,12-lead ECG)
DEQ
Time frame: from baseline to day2
Drug effect questionnaire,
OWS
Time frame: from baseline to day3
Opiate Withdrawal Scale

11 secondary outcomes

AUC0-t
Time frame: baseline and 48 hours after administration
AUC0-∞
Time frame: baseline and 48 hours after administration
Cmax
Time frame: baseline and 48 hours after administration
Tmax
Time frame: baseline and 48 hours after administration
T1/2
Time frame: baseline and 48 hours after administration
CL
Time frame: baseline and 48 hours after administration
Vd
Time frame: baseline and 48 hours after administration
MRT
Time frame: baseline and 48 hours after administration
λz
Time frame: baseline and 48 hours after administration
PD profile : Cold Pain Test
Time frame: baseline and 8 hours after administration
PD profile : Pupillometry
Time frame: baseline and 8 hours after administration

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 17 May 2023.

Related trials for Healthy

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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?

A Phase 1 study testing LPM3480392 in people with Healthy, run by Luye Pharma Group Ltd. at 1 site in China.

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 5 inclusion and 9 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 17 May 2023. 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?

Incidents of AE (including SAE) (time frame: from baseline to day8). The study lists 3 primary outcomes in all. 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 NCT05862974.

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 17 May 2023.