Multiple SclerosisPhase 1NCT05432713
A Study of LP-168 in Healthy Volunteers
A Phase 1 study testing LP-168 tablet in people with Multiple Sclerosis and NMO Spectrum Disorder, run by Guangzhou Lupeng Pharmaceutical Company LTD. at 1 site in China.
Trial summary
This is a Phase I study designed to assess the safety, tolerability and pharmacokinetics of LP-168 in healthy human volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, NMO Spectrum Disorder
- What is being tested?
- LP-168 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2022to 28 Dec 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects have no history of serious digestive system, central nervous system, cardiovascular system, kidney, respiratory system, metabolism and endocrine, skeletal and muscular system, blood system disease and cancer
- Subjects (including partners) are willing to take effective contraception measures during study and within 3 months after last dose
- Male and female healthy subjects aged 18 to 55 years old
- Male subjects weigh ≥ 50 kg, and female subjects weigh ≥ 45 kg
- Subjects able to understand and comply with study requirements
- Willing to sign the informed consent
Who cannot join
- Abnormal vital signs, physical examination or laboratory tests with clinical significance
- Abnormal ECG or echocardiography with clinical significance
- Hepatitis B virus, Hepatitis C virus, HIV and syphilis test positive. COVID-19 DNA positive.
- Subjects who have taken any drugs or health care products within 14 or 28 days before administration the study drug
- Subjects who have consumed diets that may alter the activity of liver metabolic enzymes within 7 days before administration the study drug
- Subjects who have consumed tea or alcohol-containing food product within 24hrs before administration the study drug
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- Subjects who have a history of dysphagia or condition may affect drug absorption, distribution, metabolism and excretion
- Female subjects are breastfeeding or pregnant
- Subjects who have a history of drug/ alcohol/ tobacco abuse
- Subjects who have had a blood donation or massive blood loss within three months before screening; or had surgery within six months before screening
- Subjects who have participated in other clinical trial within three months before screening
- Subjects have special dietary requirements or cannot tolerate a standard meal
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LP-168 Following Single and Multiple Oral Administration to Healthy Volunteers
This is a Phase I study designed to assess the safety, tolerability and pharmacokinetics of LP-168 in healthy human volunteers.
Read the detailed description
This study will enroll 70 healthy subjects, will set 4 SAD and 3 MAD dose cohorts, with 10 subjects in each dose cohort. Subjects will be assigned to L-168 or placebo group by ratio of 8:2 in each cohort. Sentinel subjects will be used in each dose cohort during the single dose phase.
- Conditions
- Multiple Sclerosis, NMO Spectrum Disorder
- Being tested
- LP-168 tablet, LP-168 Placebo tablet
- Medical subject headings
- Multiple Sclerosis, Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LP-168 tabletDrug
Also called NWP-775
Lp-168 is a small molecule kinase inhibitor that is administered once daily via oral administration
LP-168 Placebo tabletDrug
Also called NWP-775 Placebo
LP-168 placebo tablets contain excipients for LP-168 tablets, but do not contain the active ingredients of the drug, and are used for comparison in clinical trials with the same usage and dosage as LP-168 tablets
| Study group | Role | What they receive |
|---|---|---|
| LP-168 tablet | Experimental | After confirmation of inclusion, subjects will be randomized into the LP-168 tablet or LP-168 placebo tablet arm and receive single or multiple doses of LP-168 tablet or LP-168 placebo tablet. Receives: Drug: LP-168 tablet |
| LP-168 Placebo tablet | Placebo comparator | After confirmation of inclusion, subjects will be randomized into the LP-168 tablet or LP-168 placebo tablet arm and receive single or multiple doses of LP-168 tablet or LP-168 placebo tablet. Receives: Drug: LP-168 Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events as determined by CTCAE v5.0
Measured: From the first dose of the study drug to 5 days after last dose
Severity of Treatment Emergent Adverse Events as determined by CTCAE v5.0
Measured: From the first dose of the study drug to 5 days after last dose
Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) of LP-168
Measured: Up to 96 hours post last dose
PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To The Time of The Last Quantifiable Concentration (AUC0-t) Of LP-168
Measured: Up to 96 hours post last dose
PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) of LP-168
Measured: Up to 96 hours post last dose
PK As Assessed By Terminal Half-life (t1/2) of LP-168
Measured: Up to 96 hours post last dose
PK As Assessed By Terminal Vd/F of LP-168
Measured: Up to 96 hours post last dose
PK As Assessed By Terminal CL/F of LP-168
Measured: Up to 96 hours post last dose
Secondary outcomes (1)
PD as Assessed by elisa analysis the proportion of LP-168 occupied kinase at scheduled timepoints pre-dose and post-dose
Measured: Up to 48 hours post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start14 May 2022
- Primary completion20 Nov 2022
- Study completion28 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Guangzhou Lupeng Pharmaceutical Company 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinliang Chen, PhD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432713
- Sponsor's protocol ID
- LP-168-CN102
- Status last verified
- Feb 2023
- First submitted
- 14 Jun 2022
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LP-168 Following Single and Multiple Oral Administration to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05432713
- Acronym / sponsor ID
- LP-168-CN102
- Conditions
- Multiple Sclerosis, NMO Spectrum Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD.Industry (pharma, biotech, devices)
- Study start
- 14 May 2022 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 27 Jun 2022 (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.
This is a Phase I study designed to assess the safety, tolerability and pharmacokinetics of LP-168 in healthy human volunteers.
Detailed description
This study will enroll 70 healthy subjects, will set 4 SAD and 3 MAD dose cohorts, with 10 subjects in each dose cohort. Subjects will be assigned to L-168 or placebo group by ratio of 8:2 in each cohort. Sentinel subjects will be used in each dose cohort during the single dose phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LP-168 tablet | Experimental | Drug: LP-168 tabletAfter confirmation of inclusion, subjects will be randomized into the LP-168 tablet or LP-168 placebo tablet arm and receive single or multiple doses of LP-168 tablet or LP-168 placebo tablet. |
| LP-168 Placebo tablet | Placebo comparator | Drug: LP-168 Placebo tabletAfter confirmation of inclusion, subjects will be randomized into the LP-168 tablet or LP-168 placebo tablet arm and receive single or multiple doses of LP-168 tablet or LP-168 placebo tablet. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects have no history of serious digestive system, central nervous system, cardiovascular system, kidney, respiratory system, metabolism and endocrine, skeletal and muscular system, blood system disease and cancer
- Subjects (including partners) are willing to take effective contraception measures during study and within 3 months after last dose
- Male and female healthy subjects aged 18 to 55 years old
- Male subjects weigh ≥ 50 kg, and female subjects weigh ≥ 45 kg
- Subjects able to understand and comply with study requirements
Key exclusion criteria (12 listed)
- Abnormal vital signs, physical examination or laboratory tests with clinical significance
- Abnormal ECG or echocardiography with clinical significance
- Hepatitis B virus, Hepatitis C virus, HIV and syphilis test positive. COVID-19 DNA positive.
- Subjects who have taken any drugs or health care products within 14 or 28 days before administration the study drug
- Subjects who have consumed diets that may alter the activity of liver metabolic enzymes within 7 days before administration the study drug
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 |
|---|---|---|
| LP-168 tabletAlso: NWP-775Lp-168 is a small molecule kinase inhibitor that is administered once daily via oral administration | Drug | LP-168 tablet |
| LP-168 Placebo tabletAlso: NWP-775 PlaceboLP-168 placebo tablets contain excipients for LP-168 tablets, but do not contain the active ingredients of the drug, and are used for comparison in clinical trials with the same usage and dosage as LP-168 tablets | Drug | LP-168 Placebo tablet |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events as determined by CTCAE v5.0
Time frame: From the first dose of the study drug to 5 days after last dose
Severity of Treatment Emergent Adverse Events as determined by CTCAE v5.0
Time frame: From the first dose of the study drug to 5 days after last dose
Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) of LP-168
Time frame: Up to 96 hours post last dose
PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To The Time of The Last Quantifiable Concentration (AUC0-t) Of LP-168
Time frame: Up to 96 hours post last dose
PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) of LP-168
Time frame: Up to 96 hours post last dose
PK As Assessed By Terminal Half-life (t1/2) of LP-168
Time frame: Up to 96 hours post last dose
PK As Assessed By Terminal Vd/F of LP-168
Time frame: Up to 96 hours post last dose
PK As Assessed By Terminal CL/F of LP-168
Time frame: Up to 96 hours post last dose
1 secondary outcome
PD as Assessed by elisa analysis the proportion of LP-168 occupied kinase at scheduled timepoints pre-dose and post-dose
Time frame: Up to 48 hours post last dose
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 24 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Jinliang Chen, PhD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
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 LP-168 tablet in people with Multiple Sclerosis and NMO Spectrum Disorder, run by Guangzhou Lupeng Pharmaceutical Company 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 6 inclusion and 12 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 24 Feb 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. Some participants in this study may receive a placebo. 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 Participants With Treatment Emergent Adverse Events as determined by CTCAE v5.0 (time frame: From the first dose of the study drug to 5 days after last dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2023.