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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
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This trial is conducted in China. The aim of the trial is to investigate safety, tolerability, and pharmacokinetics of the Mulberry Twig Alkaloids tablets (WH006) in healthy ,overweight and obesity subjects.
This is a Phase I clinical trial of safety, tolerability and pharmacokinetics of the Mulberry Twig Alkaloids tablets (WH006) in healthy and overweight or obesity subjects. This trial is divided into three parts:
The first part study aims to compare the pharmacokinetics characteristics of WH006 chewing with the first bite of a standardized meal or swallowing after a standardized meal in healthy subjects.
The second part study aims to investigate the safety, tolerability and pharmacokinetics of single ascending doses of WH006 in healthy subjects.
The third part study aims to investigate the safety, tolerability and pharmacokinetics of multiple ascending doses of WH006 in both healthy participants and overweight or obese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chewing or swallowing with single dose of WH006 in healthy subjects(Part One) | Experimental | Administered by chewing with meals or swallowing after meals, with a dosage of 126 milligrams, given as a single dose only in healthy subjects. |
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| single dose ascending of WH006 in healthy subjects (Part Two) | Experimental | Administered by swallowing after meals with a single dose, four dose groups were performed sequentially in healthy subjects. |
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| multiple dose ascending of WH006 in healthy subjects (Part Three) | Experimental | Administered by swallowing after meals, taken three times daily; two dose groups were performed sequentially in healthy subjects. |
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| multiple dose ascending of WH006 in overweight or obese subjects(Part Three) | Experimental | Administered by swallowing after meals, taken three times daily; two dose groups were performed sequentially in overweight or obese subjects. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Mulberry Twig Alkaloids Tablets 126 mg single dose in healthy subjects | Drug | Part One: Administered by chewing with meals or swallowing after meals, with a dosage of 126 milligrams, given as a single dose only. |
| Measure | Description | Time Frame |
|---|---|---|
| All reported adverse events, serious adverse events and the percentage of drug-related adverse events, serious adverse events(Part Two and Part Three) | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported. | Part Two: From Day 1 to Day 4; Part Three: From Day 1 to Day 12. |
| To compare the Cmax of chewing or swallowing of WH006 with single dose(Part One) | To measure the peak drug concentration of Mulberry Twig Alkaloids(1-deoxynojirimycin(DNJ), 1,4-dideoxy-1,4-imino-D-arabinitol(DAB), Fagomine (FA))with the first bite of a standardized meal or swallowing after a standardized meal | Part One: From Day 1 to Day 2, Day 5 to Day 6; |
| To compare the AUC0-32h of chewing or swallowing of WH006 with single dose(Part One) | To measure the area under the concentration-time curve from time zero to time 32 hours of Mulberry Twig Alkaloids(1-deoxynojirimycin(DNJ), 1,4-dideoxy-1,4-imino-D-arabinitol(DAB), Fagomine (FA))with the first bite of a standardized meal or swallowing after a standardized meal | Part One: From Day 1 to Day 2, Day 5 to Day 6; |
| To compare the AUC0-inf of chewing or swallowing of WH006 with single dose(Part One) | To measure the area under the concentration time curve from time zero to time infinity of Mulberry Twig Alkaloids(1-deoxynojirimycin(DNJ), 1,4-dideoxy-1,4-imino-D-arabinitol(DAB), Fagomine (FA))with the first bite of a standardized meal or swallowing after a standardized meal | Part One: From Day 1 to Day 2, Day 5 to Day 6; |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the Cmax of WH006 with escalating single dose in healthy subjects(Part Two and Part Three) | To measure the peak drug concentration of Mulberry Twig Alkaloids(1-deoxynojirimycin(DNJ), 1,4-dideoxy-1,4-imino-D-arabinitol(DAB), Fagomine (FA)) with escalating single dose in healthy subjects. | Part Two: From Day 1 to Day 2;Part Three: From Day 1 to Day 2, Day 8 to Day 10. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ying Gao, MD | Peking University First Hospital | Principal Investigator |
| Xia Zhao, Master | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
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| Mulberry Twig Alkaloids Tablets with single dose in healthy subjects | Drug | Parts Two: Administered by swallowing after meals with four distinct dosage groups. |
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| Mulberry Twig Alkaloids Tablets with multiple dose in healthy subjects | Drug | Part Three: Administered by swallowing after meals with two distinct dosage groups, taken three times daily. |
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| Mulberry Twig Alkaloids Tablets with multiple dose in overweight or obese subjects | Drug | Part Three: Administered by swallowing after meals with two distinct dosage groups, taken three times daily. |
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| To determine the AUC0-48 of WH006 with escalating single dose in healthy subjects(Part Two and Part Three) | To measure the area under the concentration-time curve from time zero to time 48 hours of Mulberry Twig Alkaloids(1-deoxynojirimycin(DNJ), 1,4-dideoxy-1,4-imino-D-arabinitol(DAB), Fagomine (FA)) with escalating single dose in healthy subjects. | Part Two: From Day 1 to Day 2;Part Three: From Day 1 to Day 2, Day 8 to Day 10. |
| To determine the AUC0-inf of WH006 with escalating single dose in healthy subjects(Part Two and Part Three) | To measure the area under the concentration-time curve from time zero to time infinity of Mulberry Twig Alkaloids(1-deoxynojirimycin(DNJ), 1,4-dideoxy-1,4-imino-D-arabinitol(DAB), Fagomine (FA)) with escalating single dose in healthy subjects. | Part Two: From Day 1 to Day 2;Part Three: From Day 1 to Day 2, Day 8 to Day 10. |
| To determine the Cmax,ss of WH006 with escalating multiple dose in healthy and overweight or obese subjects(Part Three) | To measure the maximum concentration at steady state of Mulberry Twig Alkaloids(1-deoxynojirimycin(DNJ), 1,4-dideoxy-1,4-imino-D-arabinitol(DAB), Fagomine (FA)) with escalating multiple dose in healthy and overweight or obese subjects. | Part Three: From Day 1 to Day 10; |
| To determine the Cmin,ss of WH006 with escalating multiple dose in healthy and overweight or obese subjects(Part Three) | To measure the trough plasma concentration at steady state of Mulberry Twig Alkaloids(1-deoxynojirimycin(DNJ), 1,4-dideoxy-1,4-imino-D-arabinitol(DAB), Fagomine (FA)) with escalating multiple dose in healthy and overweight or obese subjects. | Part Three: From Day 1 to Day 10; |
| To determine the Cav,ss of WH006 with escalating multiple dose in healthy and overweight or obese subjects(Part Three) | To measure the average concentration at steady state of Mulberry Twig Alkaloids(1-deoxynojirimycin(DNJ), 1,4-dideoxy-1,4-imino-D-arabinitol(DAB), Fagomine (FA)) with escalating multiple dose in healthy and overweight or obese subjects. | Part Three: From Day 1 to Day 10; |
| To determine the AUC0-tau of WH006 with escalating multiple dose in healthy and overweight or obese subjects(Part Three) | To measure the area under the concentration-time curve from time zero to 5 hours, 14 hours and 24hours of Mulberry Twig Alkaloids(1-deoxynojirimycin(DNJ), 1,4-dideoxy-1,4-imino-D-arabinitol(DAB), Fagomine (FA)) with escalating multiple dose in healthy and overweight or obese subjects. | Part Three: From Day 1 to Day 10; |
| To determine the Rac of WH006 with escalating multiple dose in healthy and overweight or obese subjects(Part Three) | To calculate the Rac (Cmax), Rac (AUC0-5),the Rac (AUC0-14), the Rac (AUC0-24), the Rac (AUC0-inf) with the ratio of D8 parameters and D1 parameters of Mulberry Twig Alkaloids(1-deoxynojirimycin(DNJ), 1,4-dideoxy-1,4-imino-D-arabinitol(DAB), Fagomine (FA)) with escalating multiple dose in healthy and overweight or obese subjects. | Part Three: From Day 1 to Day 10; |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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