Dose Escalating Study of BPI-3016 in Healthy Subjects

Healthy Subject Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03188848
• Other study ID #: BTP-20211-01
• Status: Recruiting
• Phase: Phase 1
• Start date: May 24, 2017
• Est. completion date: December 2019

Study information

• Verified date: July 2018
• Source: Betta Pharmaceuticals Co.,Ltd.
• Contact: Kexin Li, MD
• Phone: 13501238006
• Email: kexinli6202[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: December 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subject

Intervention

Drug:
• BPI-3016
Single-dose subcutaneous injection of BPI-3016
• Placebo
Single-dose subcutaneous injection of placebo to match BPI-3016

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Plasma Concentrations of single-dose BPI-3016	The concentration of BPI-3016 following single-dose administration was estimated	15 days
Primary	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
Primary	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
Primary	T1/2	The half-life (t1/2) of single-dose BPI-3016 was measured	15 days
Secondary	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
Secondary	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