Overview

Dose Escalating Study of BPI-3016 in Healthy Subjects

Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Betta Pharmaceuticals Co., Ltd.
Betta Pharmaceuticals Co.,Ltd.
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