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The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of continuous oral administration of DA-302168S tablets for 28 days in overweight/obese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DA-302168S | Experimental |
| |
| Placebo of DA-302168S | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-302168S | Drug | Titration was used in this study, and the initial plan was to dose titration in cohort 1 (15 mg dose group). The titration regimen and titration dose for subsequent cohorts will be determined based on the results of cohort 1, including the starting dose of titration, frequency of administration, and titration amplitude. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0. | Through study completion, an average of 49 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Plasma samples were collected at different points for pharmacokinetic analysis. | Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28. |
| Tmax | Plasma samples were collected at different points for pharmacokinetic analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Hu, Doctor | The Second Hospital of Anhui Medical University | Principal Investigator |
| Yi Jun Du, Doctor | The Second Hospital of Anhui Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230000 | 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 | Titration was used in this study, and the initial plan was to dose titration in cohort 1 (15 mg dose group). The titration regimen and titration dose for subsequent cohorts will be determined based on the results of cohort 1, including the starting dose of titration, frequency of administration, and titration amplitude. |
|
| Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28. |
| AUC0-t | Plasma samples were collected at different points for pharmacokinetic analysis. | Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28. |
| Cmin | Plasma samples were collected at different points for pharmacokinetic analysis. | Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28. |
| PTR | Plasma samples were collected at different points for pharmacokinetic analysis. | Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28. |
| Swing | Plasma samples were collected at different points for pharmacokinetic analysis. | Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28. |
| Body Weight | Percentage change in body weight from baseline. | Day 1, 8, 15, 22, 29. |
| Changes in glycosylated hemoglobin (HbA1c) relative to baseline after 28 days of administration. | Blood samples will be assessed for HbA1c (glycated hemoglobin) | Day 1, 29. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |