Clinical trial NCT03188848: Dose Escalating Study of BPI-3016 in 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Subject
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-15
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of subjects with adverse events and serious adverse events
timeFrame: 1 month
measure: Plasma Concentrations of single-dose BPI-3016
timeFrame: 15 days
measure: Tmax of single-dose BPI-3016
timeFrame: 15 days
measure: AUC
timeFrame: 15 days
measure: T1/2
timeFrame: 15 days
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose
timeFrame: 8 days
measure: Change From Baseline in 2 hours postprandial blood glucose
timeFrame: 8 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
Study officials:
affiliation: Beijing Hospital
name: Kexin Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Hospital
name: Lixin Guo
role: PRINCIPAL_INVESTIGATOR
References: