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This is a randomized, double-blind, placebo-controlled, dose finding study evaluating the safety, pharmacokinetics and pharmacodynamics of subcutaneously injected BPI-3016 in Chinese healthy subjects.
BPI-3016 is a novel analogue of glucagon-like peptide-1 (GLP-1) that developed for the treatment of type 2 diabetes mellitus. This is a randomized, double-blind, placebo-controlled, dose finding study evaluating the safety, pharmacokinetics and pharmacodynamics of subcutaneously injected BPI-3016 in Chinese healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BPI-3016 | Experimental | Single-dose subcutaneous injection of BPI-3016 with escalating dose from 0.6 mg |
|
| Placebo | Placebo Comparator | Single-dose subcutaneous injection of placebo to match BPI-3016 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPI-3016 | Drug | Single-dose subcutaneous injection of BPI-3016 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events and serious adverse events | An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgement will be categorized as SAE | 1 month |
| Plasma Concentrations of single-dose BPI-3016 | The concentration of BPI-3016 following single-dose administration was estimated | 15 days |
| Tmax of single-dose BPI-3016 | Time of the maximum observed plasma concentration (tmax) following single-dose administration of BPI-3016 was estimated | 15 days |
| AUC | The area under the concentration-time (AUC) curve from time zero to the last quantifiable concentration (0-last) and AUC (0-inf) of BPI-3016 were measured | 15 days |
| T1/2 | The half-life (t1/2) of single-dose BPI-3016 was measured | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose | Fasting Plasma Glucose was measured pre-dose at baseline, day 2, day 3, day 4, day 5, and day 8 | 8 days |
| Change From Baseline in 2 hours postprandial blood glucose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kexin Li, MD | Contact | 13501238006 | kexinli6202@163.com | |
| Lixin Guo | Contact | glx1218@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Kexin Li | Beijing Hospital | Principal Investigator |
| Lixin Guo | Beijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Recruiting | Beijing | Beijing Municipality | 100005 | China |
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| ID | Term |
|---|---|
| C000625859 | BPI-3016 |
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| Placebo |
| Drug |
Single-dose subcutaneous injection of placebo to match BPI-3016 |
|
Fasting Plasma Glucose was measured pre-dose at baseline, day 2, day 3, day 4, day 5, and day 8
| 8 days |