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
1 other identifier
interventional
63
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2017
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 24, 2017
CompletedFirst Submitted
Initial submission to the registry
June 13, 2017
CompletedFirst Posted
Study publicly available on registry
June 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJanuary 2, 2019
July 1, 2018
2.1 years
June 13, 2017
December 29, 2018
Conditions
Outcome Measures
Primary Outcomes (5)
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 Outcomes (2)
Change From Baseline in Fasting Plasma Glucose
8 days
Change From Baseline in 2 hours postprandial blood glucose
8 days
Study Arms (2)
BPI-3016
EXPERIMENTALSingle-dose subcutaneous injection of BPI-3016 with escalating dose from 0.6 mg
Placebo
PLACEBO COMPARATORSingle-dose subcutaneous injection of placebo to match BPI-3016
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Hospital
Beijing, Beijing Municipality, 100005, China
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Kexin Li
Beijing Hospital
- PRINCIPAL INVESTIGATOR
Lixin Guo
Beijing Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2017
First Posted
June 15, 2017
Study Start
May 24, 2017
Primary Completion
July 1, 2019
Study Completion
December 1, 2019
Last Updated
January 2, 2019
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share