Dose Escalating Study of BPI-3016 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Randomized, Double-blind, Placebo Controlled, Dose Finding Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BPI-3016 in Healthy Subjects

Conditions
-----------------
Healthy Subject

Intervention / Treatment
-----------------
* Drug: BPI-3016
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Subject's body mass index (BMI) is >=19 kilogram (kg)/meter(m)^2 and <=25 kg/m^2 Male or female: if she is not pregnant (as confirmed by a test at screening and at other timepoints), not lactating, and at least one of the following conditions applies: a) cannot bear children OR b) agrees to follow contraception requirements defined in the protocol Capable of giving signed informed consent Exclusion Criteria: Family history of multiple endocrine neoplasia, medullary carcinoma of the thyroid, or diabetes mellitus History of thymus disease, acute or chronic pancreatitis, or thyroid dysfunction History of gallstones, biliary motility dysfunction, cholecystitis or other gallbladder disease History of weight loss over 5% within 3 months of the study Abnormal blood pressure Abnormal blood routine, blood chemistry or test at screening Personal or family history of long QT syndrome, QT interval > 450 milliseconds (msec), or heart rate is >100 beats/min at Screening History of sensitivity or contraindication to any of the study medications or components thereof or a history of drug or other allergy A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result, or a positive test for Human immunodeficiency virus (HIV) antibody A positive pre-study drug/alcohol screen The subject participated in a clinical trial and received an investigational product within 90 days History of drug or other allergy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BPI-3016<br>Single-dose subcutaneous injection of BPI-3016 with escalating dose from 0.6 mg | Drug: BPI-3016<br>* Single-dose subcutaneous injection of BPI-3016<br>|
| Placebo Comparator: Placebo<br>Single-dose subcutaneous injection of placebo to match BPI-3016 | Drug: Placebo<br>* Single-dose subcutaneous injection of placebo to match BPI-3016<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Fasting Plasma Glucose was measured pre-dose at baseline, day 2, day 3, day 4, day 5, and day 8 | 8 days |