Dose Escalating Study of BPI-3016 in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-24

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Subject

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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BPI-3016

Single-dose subcutaneous injection of BPI-3016 with escalating dose from 0.6 mg

Group Type EXPERIMENTAL

BPI-3016

Intervention Type DRUG

Single-dose subcutaneous injection of BPI-3016

Placebo

Single-dose subcutaneous injection of placebo to match BPI-3016

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single-dose subcutaneous injection of placebo to match BPI-3016

Interventions

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BPI-3016

Single-dose subcutaneous injection of BPI-3016

Intervention Type DRUG

Placebo

Single-dose subcutaneous injection of placebo to match BPI-3016

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes