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To Evaluate the Safety, Tolerability and Pharmacokinetics on DA-302168S Tablets in Randomized, Double-blind, Placebo-controlled Single-dose and Multiple-dose ascending Phase I Clinical Trials in Healthy Subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DA-302168S | Experimental | This study includes single-dose ascending and multiple-dose ascending studies. SAD study may contain 7 dose groups of 2.5 mg, 7.5 mg, 15 mg, 30mg, 50mg, 75mg and 100 mg. MAD study contains 1-4 dose groups which were evaluated in SAD study to be tolerated. |
|
| Placebo of DA-302168S | Placebo Comparator | This study includes single-dose ascending and multiple-dose ascending studies. SAD study may contain 7 dose groups of 2.5 mg, 7.5 mg, 15 mg, 30mg, 50mg, 75mg and 100 mg. MAD study contains 1-4 dose groups which were evaluated in SAD study to be tolerated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-302168S | Drug | SAD study may cotain 7 cohorts at dosage of 2.5 mg, 7.5 mg, 15 mg, 30 mg, 50 mg, 75 mg, 100 mg. Each cohort enrolls 6 subjects receive DA-302168S tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0. | SAD up to Day 5 and MAD up to Day 9. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Plasma samples were collected at different points for pharmacokinetic analysis. | Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study. |
| Tmax |
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Inclusion Criteria:
Exclusion Criteria:
subjects with a history of abnormal clinical presentation, diseases to be excluded, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, endocrine system, renal, hepatic, gastrointestinal, respiratory, metabolic, and skeletal systems, and a history of malignant tumors, which are judged to be clinically significant by the Investigator.
Use of any medication (including prescription, over-the-counter, herbal, etc.) or nutraceutical within 14 days prior to the first dose.
May have any contraindications, allergies or hypersensitivity to DA-302168S Tablets (both test drug and placebo) or its excipients, GLP-1RA, DPP-4 analogues.
Previous family history of medullary thyroid carcinoma or type 2 multiple endocrine adenoma syndrome.
History or evidence of any of the following conditions:
Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg prior to the first dose and who, in the opinion of the investigator, are not suitable for participation in the study.
Those who screen positive for substance abuse or have a history of substance abuse within the past five years or have used drugs in the 3 months prior to screening.
Those who have participated in a clinical trial of another drug within 3 months prior to screening and have received any of the clinical trial drugs.
Elective surgery was planned during the study period.
Those who have donated or lost ≥200mL of blood, received a blood transfusion, or used blood products within 3 months prior to screening.
Female subjects are pregnant or lactating.
Those who consumed excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day, or who consumed tea, coffee and/or caffeinated beverages within 48 hours prior to the first dose of the drug, or who were unable to discontinue consumption during the trial period
Previous chronic intake of xanthine- or grapefruit-rich beverages or foods, or consumption of any xanthine- or grapefruit-rich product within 48 hours prior to the first dose.
Smokers or those who smoked an average of ≥5 cigarettes per day in the 3 months prior to screening, or those who were unable to stop using any tobacco-based products during the trial.
Heavy drinkers or regular drinkers in the 3 months prior to screening, i.e., those who consume more than 14 standardized units of alcohol per week (1 unit of alcohol = 360 mL of beer or 45 mL of 40% alcohol by volume spirits or 150 mL of wine) or those who have a positive breath test for alcohol at baseline or who are unable to discontinue the use of any alcohol-containing product during the test period.
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| Name | Affiliation | Role |
|---|---|---|
| Juan Li, Doctor | Gulou Hospital Affiliated to Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gulou Hospital Affiliated to Nanjing Medical University | Nanjing | Jiangsu | 210008 | China |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Placebo of DA-302168S | Drug | SAD study may cotain 7 cohorts at dosage of 2.5 mg, 7.5 mg, 15 mg, 30 mg, 50 mg, 75 mg, 100 mg. Each cohort enrolls 2 subjects receive placebo of DA-302168S tablets. |
|
| DA-302168S | Drug | MAD study may cotain 1-4 cohorts which were evaluated in SAD study to be tolerated . Each cohort enrolls 8 subjects receive study DA-302168S tablets. |
|
| Placebo of DA-302168S | Drug | MAD study may cotain 1-4 cohorts which were evaluated in SAD study to be tolerated . Each cohort enrolls 2 subjects receive study placebo of DA-302168S tablets. |
|
Plasma samples were collected at different points for pharmacokinetic analysis. |
| Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study. |
| AUC0-t | Plasma samples were collected at different points for pharmacokinetic analysis. | Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study. |
| AUC0-∞ | Plasma samples were collected at different points for pharmacokinetic analysis. | Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study. |
| t1/2 | Plasma samples were collected at different points for pharmacokinetic analysis. | Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study. |
| CL/F | Plasma samples were collected at different points for pharmacokinetic analysis. | Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study. |
| Vd/F | Plasma samples were collected at different points for pharmacokinetic analysis. | Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study. |
| Kel | Plasma samples were collected at different points for pharmacokinetic analysis. | Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |