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Trial record 42 of 22300 for:    Placebo AND subjects

Dose Escalating Study of BPI-3016 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03188848
Recruitment Status : Recruiting
First Posted : June 15, 2017
Last Update Posted : January 1, 2019
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Healthy Subject Drug: BPI-3016 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo Controlled, Dose Finding Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BPI-3016 in Healthy Subjects
Actual Study Start Date : May 24, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

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




Primary Outcome Measures :
  1. Number of subjects with adverse events and serious adverse events [ Time Frame: 1 month ]
    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

  2. Plasma Concentrations of single-dose BPI-3016 [ Time Frame: 15 days ]
    The concentration of BPI-3016 following single-dose administration was estimated

  3. Tmax of single-dose BPI-3016 [ Time Frame: 15 days ]
    Time of the maximum observed plasma concentration (tmax) following single-dose administration of BPI-3016 was estimated

  4. AUC [ Time Frame: 15 days ]
    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

  5. T1/2 [ Time Frame: 15 days ]
    The half-life (t1/2) of single-dose BPI-3016 was measured


Secondary Outcome Measures :
  1. Change From Baseline in Fasting Plasma Glucose [ Time Frame: 8 days ]
    Fasting Plasma Glucose was measured pre-dose at baseline, day 2, day 3, day 4, day 5, and day 8

  2. Change From Baseline in 2 hours postprandial blood glucose [ Time Frame: 8 days ]
    Fasting Plasma Glucose was measured pre-dose at baseline, day 2, day 3, day 4, day 5, and day 8



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03188848


Contacts
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Contact: Kexin Li, MD 13501238006 kexinli6202@163.com
Contact: Lixin Guo glx1218@163.com

Locations
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China, Beijing
Beijing Hospital Recruiting
Beijing, Beijing, China, 100005
Sponsors and Collaborators
Betta Pharmaceuticals Co., Ltd.
Investigators
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Principal Investigator: Kexin Li Beijing Hospital
Principal Investigator: Lixin Guo Beijing Hospital

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Responsible Party: Betta Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT03188848     History of Changes
Other Study ID Numbers: BTP-20211-01
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: January 1, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No