the Safety, Tolerability and Pharmacokinetics of Mulberry Twig Alkaloids in Human
NCT Number: NCT06490263
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Overweight and Obesity|Healthy
Interventions: DRUG: Experimental: Mulberry Twig Alkaloids Tablets 126 mg single dose in healthy subjects|DRUG: Mulberry Twig Alkaloids Tablets with single dose in healthy subjects|DRUG: Mulberry Twig Alkaloids Tablets with multiple dose in healthy subjects|DRUG: Mulberry Twig Alkaloids Tablets with multiple dose in overweight or obese subjects
Sponsor: Beijing Wehand-Bio Pharmaceutical Co., Ltd
Collaborators: Peking University First Hospital
Sex: ALL
Age: ADULT
Enrollment: 68
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-13
Completion Date: 2024-12-10
Locations: Peking University First Hospital, Beijing, Beijing, 100034, China

Summary:
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.

Primary Outcome Measures: 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;
Secondary Outcome Measures: 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.|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;