Dose Escalating Study of BPI-3016 in Healthy Subjects

Betta Pharmaceuticals

Status and phase: Unknown; Phase 1

Conditions: Healthy Subject

Treatments: Drug: BPI-3016; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03188848

BTP-20211-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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63 participants in 2 patient groups, including a placebo group

BPI-3016

Experimental group

Description:

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

Treatment:

Drug: BPI-3016

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo