A Study of LP-168 in Healthy Volunteers
Study Details
Study Description
Brief Summary
This is a Phase I study designed to assess the safety, tolerability and pharmacokinetics of LP-168 in healthy human volunteers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LP-168 tablet 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. |
Drug: LP-168 tablet
Lp-168 is a small molecule kinase inhibitor that is administered once daily via oral administration
Other Names:
|
| Placebo Comparator: LP-168 Placebo tablet 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. |
Drug: LP-168 Placebo tablet
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
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Treatment Emergent Adverse Events as determined by CTCAE v5.0 [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 [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 [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 [Up to 96 hours post last dose]
- PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) of LP-168 [Up to 96 hours post last dose]
- PK As Assessed By Terminal Half-life (t1/2) of LP-168 [Up to 96 hours post last dose]
- PK As Assessed By Terminal Vd/F of LP-168 [Up to 96 hours post last dose]
- PK As Assessed By Terminal CL/F of LP-168 [Up to 96 hours post last dose]
Secondary Outcome Measures
- PD as Assessed by elisa analysis the proportion of LP-168 occupied kinase at scheduled timepoints pre-dose and post-dose [Up to 48 hours post last dose]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
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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
Exclusion Criteria:
-
Abnormal vital signs, physical examination or laboratory tests with clinical significance
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Abnormal ECG or echocardiography with clinical significance
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Hepatitis B virus, Hepatitis C virus, HIV and syphilis test positive. COVID-19 DNA positive.
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Subjects who have taken any drugs or health care products within 14 or 28 days before administration the study drug
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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
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Female subjects are breastfeeding or pregnant
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Subjects who have a history of drug/ alcohol/ tobacco abuse
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Subjects who have had a blood donation or massive blood loss within three months before screening; or had major 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | China | 310009 |
Sponsors and Collaborators
- Guangzhou Lupeng Pharmaceutical Company LTD.
Investigators
- Principal Investigator: Jinliang Chen, PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LP-168-CN102