Healthy SubjectPhase 1NCT03188848
Dose Escalating Study of BPI-3016 in Healthy Subjects
A Phase 1 study testing BPI-3016 in people with Healthy Subject, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject
- What is being tested?
- BPI-3016
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2017to Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Lixin Guo contact
China1 site, 1 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100005
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Subject
- Being tested
- BPI-3016, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPI-3016Drug
Single-dose subcutaneous injection of BPI-3016
PlaceboDrug
Single-dose subcutaneous injection of placebo to match BPI-3016
| Study group | Role | What they receive |
|---|---|---|
| BPI-3016 | Experimental | Single-dose subcutaneous injection of BPI-3016 with escalating dose from 0.6 mg Receives: Drug: BPI-3016 |
| Placebo | Placebo comparator | Single-dose subcutaneous injection of placebo to match BPI-3016 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Plasma Concentrations of single-dose BPI-3016
The concentration of BPI-3016 following single-dose administration was estimated
Measured: 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
Measured: 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
Measured: 15 days
T1/2
The half-life (t1/2) of single-dose BPI-3016 was measured
Measured: 15 days
Secondary outcomes (2)
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
Measured: 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
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start24 May 2017
- Primary completionJul 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectStudies of the same condition, open and under way.
- More trials run by Betta Pharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kexin Li, Principal investigator, Beijing HospitalLixin Guo, Principal investigator, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188848
- Sponsor's protocol ID
- BTP-20211-01
- Status last verified
- Jul 2018
- First submitted
- 13 Jun 2017
- Last updated
- 2 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled, Dose Finding Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BPI-3016 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03188848
- Acronym / sponsor ID
- BTP-20211-01
- Conditions
- Healthy Subject
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 May 2017 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPI-3016 | Experimental | Drug: BPI-3016Single-dose subcutaneous injection of BPI-3016 with escalating dose from 0.6 mg |
| Placebo | Placebo comparator | Drug: PlaceboSingle-dose subcutaneous injection of placebo to match BPI-3016 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPI-3016Single-dose subcutaneous injection of BPI-3016 | Drug | BPI-3016 |
| PlaceboSingle-dose subcutaneous injection of placebo to match BPI-3016 | Drug | Placebo |
Primary outcome
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
Plasma Concentrations of single-dose BPI-3016
Time frame: 15 days
The concentration of BPI-3016 following single-dose administration was estimated
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
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
T1/2
Time frame: 15 days
The half-life (t1/2) of single-dose BPI-3016 was measured
2 secondary outcomes
Change From Baseline in Fasting Plasma Glucose
Time frame: 8 days
Change From Baseline in 2 hours postprandial blood glucose
Time frame: 8 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
- Individual participant dataSharing planned: No
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lixin Guo contact
Kexin Li principal investigator
Beijing Hospital
Lixin Guo principal investigator
Beijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BPI-3016 in people with Healthy Subject, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kexin Li, MD (13501238006, kexinli6202@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events and serious adverse events (time frame: 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2019.