Dose Escalating Study of BPI-3016 in Healthy Subjects

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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Subject
• Intervention / Treatment: Drug: BPI-3016; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 63
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kexin Li, MD; Phone Number: 13501238006; Email: kexinli6202@163.com
• Study Contact Backup: Name: Lixin Guo; Email: glx1218@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100005
      • Recruiting
      • Beijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BPI-3016; Single-dose subcutaneous injection of BPI-3016 with escalating dose from 0.6 mg	Drug: BPI-3016; Single-dose subcutaneous injection of BPI-3016
PLACEBO_COMPARATOR: Placebo; Single-dose subcutaneous injection of placebo to match BPI-3016	Drug: Placebo; Single-dose subcutaneous injection of placebo to match BPI-3016

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

Collaborators and Investigators

• Sponsor: Betta Pharmaceuticals Co., Ltd.
• Investigators: Principal Investigator: Kexin Li, Beijing Hospital; Principal Investigator: Lixin Guo, Beijing Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 24, 2017
• Primary Completion (ANTICIPATED): July 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: June 13, 2017
• First Submitted That Met QC Criteria: June 13, 2017
• First Posted (ACTUAL): June 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 2, 2019
• Last Update Submitted That Met QC Criteria: December 29, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: BTP-20211-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No