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A Randomized, Double-Blind, Placebo-Controlled, Single/Multiple-dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BGM0504 Tablets Orally Administered in Healthy and Non-diabetic Overweight or Obese Chinese Subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGM0504 tablets | Experimental | Oral administration once daily |
|
| Placebo tablets | Experimental | Placebo Oral administration once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGM0504 tablets | Drug | Administered p.o. |
| |
| Placebo tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment adverse events | The relationship of each adverse event to the investigational product was assessed by the investigator | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic endpoint: Concentration of BGM0504 in plasma | 8 weeks | |
| Change in fasting weight at week 8 | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Those with a history of severe drug allergies (especially those with known or suspected allergies to the active ingredients and excipients of BGM0504 Tablets), or complicated with severe specific allergic diseases/history, or with a severe allergic constitution.
Subjects with positive results for HBsAg, anti-HCV, anti-HIV or anti-TP during the screening period.
At the screening/baseline period, any one of the laboratory test indicators meets the following criteria:
12-lead ECG shows ventricular heart rate < 50 beats/min or > 100 beats/min at screening/baseline, second or third degree atrioventricular block, long QT syndrome, QTcF> 470ms for women or > 450ms for men, pre-excitation syndrome or other significant arrhythmias.
Used illegal drugs within 6 months prior to screening, or substance abuse within 12 months prior to screening.
Participated in drug or medical device clinical trials and treated with Study Drug (excluding placebo) or medical device intervention within 12 weeks before screening.
Participants who have received any vaccine within 2 weeks prior to screening, or plan to receive a vaccine during the trial.
Female participants who are pregnant or lactating, or those with a positive pregnancy test result during the screening period.
Positive urine drug test or alcohol serum test result at screening or at baseline.
Has any other conditions or disorders deemed unsuitable for including in the study, in the opinion of the Investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianchang He | Contact | 13700680697 | hejc@yn-cprc.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Yunnan University of Chinese Medicine | Recruiting | Kunming | Yunnan | 650000 | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Drug |
Administered p.o. |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |