Type II DiabetesPhase 1NCT02084251
Clinical Trial for PB-119 in Healthy Subjects (Phase I)
A Phase 1 study testing PB-119 in people with Type II Diabetes, run by PegBio Co., Ltd. at 1 site in China.
Trial summary
GLP-1 analogues have been widely used because of their unique advantages (no risk of hypoglycemia) due to their glucose dependent mechanism. Due to the short half-life of peptide in plasma, peptides have to be administered frequently (i.e. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type II Diabetes
- What is being tested?
- PB-119
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Nov 2014
- 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
- Male or female volunteers, ages: between 18-45;
- Body weight： female >= 45kg, male >=50kg, BMI >=19-24kg/m2
- Physical examination, blood routine, urine routine, liver and kidney function and related laboratory tests are normal or slightly abnormal but not clinically significant;
- Read, agree, and sign the informed consent;
- Be able to communicate with the investigator and finish the study according to the protocol.
Who cannot join
- Allergic to the API or excipients used (citric acid, mannitol, Meta-Cresol);
- Experiencing clinically significant disease or surgery within 4 weeks before the study;
- Clinically significant disease history in systems including cardiovascular system, endocrine system, neutral system, immunology system, psychiatry，metabolic disorder;
- Disease history of gastrointestinal tract, liver, and kidney (for example, the Partial resection surgery in GI tract, liver, or kidney);
- Fever history within 3 days of the screening;
- Clinical significant abnormality found in laboratory tests (blood, urine routine test) within 2 weeks before study;
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- ECG or vital signs is clinically significant abnormality as judged by the Investigator( systolic blood pressure <90mmHg or ≥140mmHg; diastolic blood pressure<60mmHg or ≥90mmHg; heart rate <50bpm or >100bpm);
- Antibody test for HIV, BsAg, C hepatitis, or Microspironema pallidum positive;
- Alcoholics or drink frequently within 6 months of trial (more than 14 unit of alcohol, in which 1 unit is 360mL beers, or 45 ml wine with 40% alcohol content, or 150mL port wine;
- Addicted to cigarette, tea, coffee or drugs;
- Have specific requirement for diets (or allergic to any food);
- Have been administered in the past 2 weeks with any drug (such as antibiotics, anticoagulant, diuretics) that might interfere the PK profile of drug/drug candidate to be used in this study;
- Participated in any clinical trial in the past 3 months;
- Donated blood of more than 360 ml in the past 3 months;
- Plan to be pregnant herself or his spouse in the next 6 months;
- Females administered with any oral contraceptive 30 days before the study or during the study;
- Females dosed with long acting estrogen or progestin (injections or implant) 6 months before the study or during the study;
- Females at childbearing age that had unprotected intercourse 14 days before the study or will have during the study;
- Female who is pregnant or nursing;
- Anybody who might not be able to complete the study, or considered not appropriate by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100000
About this study
Official title: Safety, Tolerability and Pharmacokinetics of Single Dose of PB-119 in Healthy Volunteers
GLP-1 analogues have been widely used because of their unique advantages (no risk of hypoglycemia) due to their glucose dependent mechanism. Due to the short half-life of peptide in plasma, peptides have to be administered frequently (i.e. BID for Byetta, with Exenatide as API).To improve the patients compliance and reduce potential adverse events associated with GLP-1 analogues, a long acting GLP-1 analogue (PB-119), which may be administered once weekly, was developed by PegBio Inc. In order to provide rational for dosage range to be studied in Phase Ib, the safety profile, tolerance, and pharmacokinetic behavior of PB-119 in healthy subjects will be studied in this randomized, controlled dose escalating trial.
- Conditions
- Type II Diabetes
- Being tested
- PB-119
- Keywords
- safety,, pharmacokinetics,, Long acting GLP-1 analogue
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PB-119Drug
| Study group | Role | What they receive |
|---|---|---|
| Exenatide analogue, Injection | Experimental | PB-119 will be administered once weekly subcutaneously at dosage of 2μg、5μg、10μg、25μg、50μg、100μg、200μg or 400μg. Receives: Drug: PB-119 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/Adverse Event Outcome Measure
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type II DiabetesStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- PegBio Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuan Lv, Doctor, Principal investigator, No.1 Hospital of Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084251
- Sponsor's protocol ID
- ICP-I-2013-08
- Status last verified
- Feb 2017
- First submitted
- 9 Mar 2014
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cui H, Zhao CY, Lv Y, Wei MJ, Zhu Y, Li Y, Xia YH, Liu Y, Tian JH, Zhang P. Safety, Tolerability and Pharmacokinetics of Single Dose Polyethylene Glycolated Exenatide Injection (PB-119) in Healthy Volunteers. Eur J Drug Metab Pharmacokinet. 2020 Jun;45(3):361-369. doi: 10.1007/s13318-020-00605-9.
PubMed 32006325
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetics of Single Dose of PB-119 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02084251
- Acronym / sponsor ID
- ICP-I-2013-08
- Conditions
- Type II Diabetes
- Keywords
- safety,, pharmacokinetics,, Long acting GLP-1 analogue
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- PegBio Co., Ltd.University, hospital or other
- Study start
- Feb 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 11 Mar 2014 (estimated)
- 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.
GLP-1 analogues have been widely used because of their unique advantages (no risk of hypoglycemia) due to their glucose dependent mechanism. Due to the short half-life of peptide in plasma, peptides have to be administered frequently (i.e. BID for Byetta, with Exenatide as API).To improve the patients compliance and reduce potential adverse events associated with GLP-1 analogues, a long acting GLP-1 analogue (PB-119), which may be administered once weekly, was developed by PegBio Inc. In order to provide rational for dosage range to be studied in Phase Ib, the safety profile, tolerance, and pharmacokinetic behavior of PB-119 in healthy subjects will be studied in this randomized, controlled dose escalating trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exenatide analogue, Injection | Experimental | Drug: PB-119PB-119 will be administered once weekly subcutaneously at dosage of 2μg、5μg、10μg、25μg、50μg、100μg、200μg or 400μg. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female volunteers, ages: between 18-45;
- Body weight： female >= 45kg, male >=50kg, BMI >=19-24kg/m2
- Physical examination, blood routine, urine routine, liver and kidney function and related laboratory tests are normal or slightly abnormal but not clinically significant;
- Read, agree, and sign the informed consent;
- Be able to communicate with the investigator and finish the study according to the protocol.
Key exclusion criteria (20 listed)
- Allergic to the API or excipients used (citric acid, mannitol, Meta-Cresol);
- Experiencing clinically significant disease or surgery within 4 weeks before the study;
- Clinically significant disease history in systems including cardiovascular system, endocrine system, neutral system, immunology system, psychiatry，metabolic disorder;
- Disease history of gastrointestinal tract, liver, and kidney (for example, the Partial resection surgery in GI tract, liver, or kidney);
- Fever history within 3 days of the screening;
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 |
|---|---|---|
| PB-119 | Drug | Exenatide analogue, Injection |
Primary outcome
Safety/Adverse Event Outcome Measure
Time frame: Up to 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
- Derived from this study: PubMed 32006325Cui H, Zhao CY, Lv Y, Wei MJ, Zhu Y, Li Y, Xia YH, Liu Y, Tian JH, Zhang P. Safety, Tolerability and Pharmacokinetics of Single Dose Polyethylene Glycolated Exenatide Injection (PB-119) in Healthy Volunteers. Eur J Drug Metab Pharmacokinet. 2020 Jun;45(3):361-369. doi: 10.1007/s13318-020-00605-9.
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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.
Yuan Lv, Doctor principal investigator
No.1 Hospital of Peking University
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 PB-119 in people with Type II Diabetes, run by PegBio 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 5 inclusion and 20 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: finished, as of the sponsor's last update on 14 Feb 2017. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety/Adverse Event Outcome Measure (time frame: Up to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02084251, which also lists 1 linked publication.
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 14 Feb 2017.