A Study of LP-128 Capsules in Healthy Subjects
Study Details
Study Description
Brief Summary
A Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of LP-128 Capsules After Single- and Multiple-Dose in Healthy Subjects
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
This trial includes single dose and multiple dose phases. The single-dose phase included six dose cohorts. Based on the safety and pharmacokinetic results of single-dose study, approximately 2 doses will be selected to conduct multiple-dose study. The primary study objectives are to evaluate the safety, tolerability, and pharmacokinetic characteristics (including food effect and mass balance) of LP-128 capsules in healthy subjects after single and multiple dosing.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single-dose Experimental Group
|
Drug: LP-128 capsules
Adaptive oral dosing with LP-128 capsules,with ascending or adjusted dosing based on the results of previous dosing.
Other Names:
|
| Placebo Comparator: Single-dose Control Group
|
Other: Matching Placebo
Oral dosing with placebo capsules to match LP-128 capsules.
|
| Experimental: Food Effect Experimental Group
|
Drug: LP-128 capsules
Adaptive oral dosing with LP-128 capsules,with ascending or adjusted dosing based on the results of previous dosing.
Other Names:
|
| Placebo Comparator: Food Effect Control Group
|
Other: Matching Placebo
Oral dosing with placebo capsules to match LP-128 capsules.
|
| Experimental: Multi-dose Experimental Group
|
Drug: LP-128 capsules
Adaptive oral dosing with LP-128 capsules,with ascending or adjusted dosing based on the results of previous dosing.
Other Names:
|
| Placebo Comparator: Multi-dose Control Group
|
Other: Matching Placebo
Oral dosing with placebo capsules to match LP-128 capsules.
|
Outcome Measures
Primary Outcome Measures
- Area under the plasma concentration-time curve (AUC) of LP-128 under fasted state [Up to 7 and 21 days in Single-dose group and Multi-dose group, respectively]
Plasma samples were collected at different points for pharmacokinetic analysis
- Apparent terminal phase half-life (T1/2) of LP-128 under fasted state [Up to 7 and 21 days in Single-dose group and Multi-dose group, respectively]
Plasma samples were collected at different points for pharmacokinetic analysis
- Maximum observed plasma concentration (Cmax) of LP-128 under fasted state [Up to 7 and 21 days in Single-dose group and Multi-dose group, respectively]
Plasma samples were collected at different points for pharmacokinetic analysis
- Adverse events of LP-128 [Up to 28 days]
The incidence and severity of adverse events as assessed by NCI CTCAE v5.0.
Secondary Outcome Measures
- excretion of LP-128 in urine [Up to 7 days]
Urine samples will be collected at different points for pharmacokinetic analysis
- excretion of LP-128 in feces [Up to 7 days]
feces samples will be collected at different points for pharmacokinetic analysis
- Area under the plasma concentration-time curve (AUC) of LP-128 after meal [Up to 14 days]
Blood samples will be collected at different points for pharmacokinetic analysis
- Apparent terminal phase half-life (T1/2) of LP-128 after meal [Up to 14 days]
Blood samples will be collected at different points for pharmacokinetic analysis
- Maximum observed plasma concentration (Cmax) of LP-128 after meal [Up to 14 days]
Blood samples will be collected at different points for pharmacokinetic analysis
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
-
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 and fully understand the content, process and possible adverse reactions of the trial
Exclusion Criteria:
-
Abnormal vital signs, physical examination or laboratory tests with clinical significance
-
Abnormal ECG or echocardiography with clinical significance
-
Positive screening for viral hepatitis, HIV and syphilis
-
Subjects who have taken any drugs or health care products within 14 or 28 days before administration the study drug; or subjects who have consumed tea or alcohol-containing food product within 24hrs before administration the study drug
-
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 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
-
Subjects who are not suitable for this trial based on the assessment of investigator
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NanFang Hospital of Southern Medical University | Guangzhou | Guangdong | China | 510515 |
Sponsors and Collaborators
- Guangzhou Lupeng Pharmaceutical Company LTD.
Investigators
- Principal Investigator: Chongyuan Xu, MD, PhD, Nanfang Hospital of Nanfang Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LP-128-CN101