Hyperlipidemia Clinical Trial
Official title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of DC371739 Single-Dose Treatment in Healthy Subjects
Verified date | March 2022 |
Source | Guangzhou JOYO Pharma Co., Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is to evaluate the safety, tolerability, pharmacokinetics of DC371739 after a single-dose oral administration in healthy Chinese subjects, and to explore the maximum tolerated dose, also the pharmacokinetics of urine and feces.
Status | Completed |
Enrollment | 43 |
Est. completion date | March 15, 2022 |
Est. primary completion date | March 19, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: 1. Aged 18-40 years, inclusive, male; 2. Weight=50kg; body mass index of 19 to 26 kg/m2, inclusive; 3. Based on the medical history, physical examination, clinical laboratory examination, 12-lead ECG and vital signs results, subjects with no evidence of active or chronic diseases, or clinically significant abnormalities; Exclusion Criteria: 1. Subjects with a history of allergy to study drug ingredients or similar drug, with a history of allergic disease or allergic constitution 2. Presence of symptoms or related history of any major disease, including but not limited to heart, liver, kidney diseases or other acute and chronic digestive tract diseases, respiratory diseases, bone and joint diseases, as well as blood, endocrine, nerve, mental and other systemic disease, or any other diseases or physiological conditions that could interfere with the results; 3. Any surgical condition or condition that may significantly affect the metabolism and excretion of drug absorption and distribution, or that may pose a hazard to the subjects participating in the study; Any surgical condition or condition that may significantly affect the absorption, distribution, metabolism, and excretion of the study drug, or any surgical condition or condition that may harm to the subjects participating in the study; 4. Subjects who donated blood or lost 400 ml of blood within 3 months prior to screening; The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Xu hui Central Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Guangzhou JOYO Pharma Co., Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Adverse Events | The relationship of each adverse event to the investigational product was assessed by the investigator.A serious adverse event (SAE) is defined as an adverse event that is fatal is life threatening (places the subject at immediate risk of death) requires in-patient hospitalization or prolongation of existing hospitalization results in persistent or significant disability/incapacity other significant medical hazard. | From the first dose of study drug until Day 15 in three arms | |
Primary | Total urine excretion rate | Urine samples will be taken at different time points for analysis in three arms | From the first dose of study drug until Day 6 | |
Primary | Total feces excretion rate | feces samples will be taken at different time points for analysis in three arms | From the first dose of study drug until Day 6 | |
Secondary | Area under the plasma concentration versus time curve (AUC(0-t)) | Blood samples will be taken at different time points before and after administration. | From the first dose of study drug until Day 6 | |
Secondary | Time to reach maximum plasma concentration (Tmax) | Blood samples will be taken at different time points before and after administration. | From the first dose of study drug until Day 6 |
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