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Type2DiabetesPhase 1NCT05328843

Study to Evaluate the Pharmacokinetic Characteristics of Pegylated Exenatide Injection (PB-119) in Subjects With Different Degrees of Renal Insufficiency and Matched Subjects With Normal Renal Function

A Phase 1 study testing PB119 in people with Type2Diabetes, run by PegBio Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a single-dose, parallel grouping, open-label phase I clinical study to evaluate the PK characteristics and safety of single subcutaneous injection of PB-119 in subjects with different degrees of renal insufficiency and matched subjects with normal renal function. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Type2Diabetes
What is being tested?
PB119
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
1 May 2022to 1 Oct 2022
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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All subjects included in this study must meet all of the following criteria:
  • Subjects who voluntarily sign the informed consent form (ICF) before the commencement of relevant activities of this study, can understand the procedures and methods of this study, and are willing to strictly abide by the clinical study protocol to complete this study;
  • Male subjects: Male subjects should voluntarily take effective contraceptive measures, and should not donate sperm from the screening period to 90 days after the administration of the study drug
  • Female subjects must meet one of the following conditions:
  • Non-fertile women
  • Fertile women should voluntarily take effective contraceptive measures from the screening period to 90 days after the administration of the study drug;
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  • According to the judgment of the investigators, the subject's physical examination, vital signs examination, 12 lead ECG examination and laboratory examination indicators are suitable for participating in this study;
  • Subjects in the renal insufficiency group must also meet the following criteria:
  • Male or female subjects aged between 18 and 75 years old;
  • The weight of male subjects should not be less than 50 kg and that of female subjects should not be less than 45 kg. BMI should be between 18 and 30 kg/m2 (including both end values);
  • Subjects with a diagnosis of chronic (> 3 months) and stable (no acute exacerbation due to renal function aggravated within 1 month before screening) renal injury, and a GFR measured during the screening period in line with 60 89 mL/min (mild renal insufficiency in group A) or 30-59 mL/min (moderate renal insufficiency in group B). Renal function evaluated by individual GFR converted from eGFR calculated according to the CKD-EPI formula;
  • Subjects in the normal renal function group must also meet the following criteria:
  • Male or female subjects aged between 18 and 75 years old, which should be matched with age (±10 years) and gender of subjects in the renal insufficiency group;
  • The weight of male subjects should not be less than 50 kg and that of female subjects should not be less than 45 kg. BMI should be between 18 and 30 kg/m2 (including both end values), which should be matched with BMI (± 15%) of subjects in renal insufficiency group;
  • The GFR of subjects with normal renal function should be ≥ 90 and < 130 mL/min (estimated by CKD-EPI formula).

Who cannot join

  • All subjects will not be included in this study if they meet any of the following criteria:
  • Those with allergic constitution or allergic to any component in PB-119;
  • Those with previous medical history or family history of Medullary thyroid cancer (MTC) or Multiple endocrine adenomatosis type 2 (MEN2), or serum calcitonin ≥ 50 pg/mL at screening;
  • Those with serum amylase or lipase >3 × upper limit of normal (ULN) during the screening period or baseline period or subjects with previous diagnosis of acute/chronic pancreatitis;
  • Those who had severe gastrointestinal diseases (such as active ulcer, gastroparesis, obstruction pyloric, inflammatory bowel disease, etc.) or underwent gastrointestinal surgery or long-term use of drugs directly affecting gastrointestinal peristalsis due to chronic gastrointestinal diseases within 6 months before screening or during the baseline period are not suitable to participate in this clinical study according to the evaluation of the investigators;
  • Those with any type of treated or untreated malignancy (whether cured or not) within 5 years before screening or during the baseline period (except basal cell carcinoma of the skin);
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  • Those who have major diseases or surgery within 4 weeks before administration, or those who are expected to be hospitalized due to surgery or other reasons during the study period;
  • Those with a history of drug abuse or a positive urine drug screening test within 5 years before screening;
  • Those who smoked more than 10 cigarettes per day on average within 3 months before screening;
  • Those with an average weekly alcohol intake of more than 14 units (female subjects) or 21 units (male subjects) (1 unit of alcohol is equivalent to 284 mL of beer, 1 glass of 125 mL of wine or 25 mL of spirits) in the 3 months prior to screening or who ingested any alcohol-containing products within 48 hours prior to administration, or those with a positive breath alcohol test;
  • Clinical investigators who have participated in any drug or medical device within 3 months before screening (subject to administration);
  • Those who donated blood (or lost blood) ≥ 400 mL or received blood products within 3 months before screening;
  • Those with acute hepatitis, chronic liver disease, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 × ULN and total bilirubin > 2 × ULN during the screening period or baseline period;
  • Those who are positive for any of the hepatitis B surface antigen (HBsAg), hepatitis C virus antibody, human immunodeficiency virus (HIV) antibody, and Treponema pallidum antibody according to the local diagnostic test;
  • Female subjects with positive pregnancy test results during the screening period or baseline period;
  • Those who are positive for the new coronavirus nucleic acid test during the screening period or baseline period;
  • Those who are unable to perform venipuncture and/or tolerate catheter venous access;
  • The investigator considers that the subject is not suitable to participate in the study due to any conditions that may cause the subject to be unable to complete the study or pose a significant risk to the subject or other factors that may reduce the possibility of enrollment;
  • Subjects in the renal insufficiency group will not be included in this study if they meet any of the following criteria:
  • Those with renal impairment with uropathy obstructive (such as urinary calculus, urinary tract obstruction caused by abdominal space-occupying lesions, etc.) or other causes unrelated to parenchymal dysfunction kidney (such as polycystic kidney, renal tumor, etc.) and/or renal diseases (such as renal artery stenosis, drugs, severe infection, insufficient blood volume, cardiac failure, etc.);
  • Those who have received renal transplant;
  • Those with average systolic blood pressure exceeding 80-180 mmHg (including both end values) or average diastolic blood pressure exceeding 50-100 mmHg (including both end values) or heart rate exceeding the range of 45-120 beats/min (including both end values) in the screening period or baseline period;
  • Those who have heart failure/hypertension, respiratory, liver, gastrointestinal, endocrine (except hyperlipidemia, untreated hyperuricemia and diabetes mellitus with stable blood glucose within the past month), blood, mental/nervous and other serious diseases within 1 year before screening and are not suitable to participate in this clinical study according to the evaluation of the investigators;
  • At screening, the therapeutic drugs and/or therapeutic drugs for other comorbidities have not been stable for at least 1 month, or there are new drugs within 1 month (except for drugs used temporarily or intermittently, such as monthly use of erythropoietin, or temporary use of diuretics, etc.), or any drugs known to change the secretion of creatinine in renal tubules within 14 days or 5 half-lives (whichever is longer) before screening, such as cimetidine, trimethoprim or sibenzoline, etc.;
  • Subjects with diabetes mellitus who have used glucagon-like peptide-1 receptor agonist (GLP-1RA) within 1 month before administration;
  • Subjects in the normal renal function group will not be included in this study if they meet any of the following criteria:
  • Those with average systolic blood pressure exceeding 90-140 mmHg (including both end values) or average diastolic blood pressure exceeding 50-90 mmHg (including both end values) or heart rate exceeding the range of 45-120 beats/min (including both end values) in the screening period or baseline period;
  • Subjects with fasting blood glucose (FPG) ≥ 7.0 mmol/L at screening (it can be re-tested at the judgment of the investigators);
  • Subjects with glycosylated hemoglobin (HbA1c) ≥ 6.5% at screening;
  • Those who have heart failure/hypertension, respiratory, liver, gastrointestinal, endocrine (except hyperlipidemia and untreated hyperuricemia), blood, mental/nervous and other serious diseases within 1 year before screening and are not suitable to participate in this clinical study according to the evaluation of the investigators;
  • Any drug (except paracetamol/acetaminophen, including over-the-counter drugs, herbal medications and dietary supplements, such as vitamins and minerals that may affect the results of the study) have been used 14 days before administration or within 5 half-lives (whichever is longer). For subjects with hyperlipidemia, statins and/or fibrates can be used, and other lipid-regulating drugs should be evaluated by the investigators and discussed with the sponsor if necessary for exclusion.

Trial locations and contacts

1 site in 1 country.

Ying Du, MD,PhD contact

+8618911797119

ying.du@pegbio.com

Michael Xu, MD,PhD contact

+86-512-62956129

michael.xu@pegbio.com

China1 site

  • Jia Miao

    Chengdu, Sichuan

    Jia Miao, MD,PhD, +86-18980601806, miaosiyi1971@163.com

    Ping Fu, MD,PhD, +86-18980601201, fupinghx@163.com

Other trials in China

About this study

Official title: An Open-label Phase I Clinical Study to Evaluate the Pharmacokinetic Characteristics of Single-dose of Pegylated Exenatide Injection (PB-119) in Subjects With Different Degrees of Renal Insufficiency and Matched Subjects With Normal Renal Function

This study is a single-dose, parallel grouping, open-label phase I clinical study to evaluate the PK characteristics and safety of single subcutaneous injection of PB-119 in subjects with different degrees of renal insufficiency and matched subjects with normal renal function.

Read the detailed description

This study plans to enroll 24 subjects, which are divided into three groups: Group A: subjects with mild renal insufficiency (chronic kidney disease [CKD] stage 2); Group B: subjects with moderate renal insufficiency (CKD3 stage 3); Group C: subjects with normal renal function. The estimated glomerular filtration rate (eGFR, mL/min/1.73m2) transformed according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula should be converted into individual glomerular filtration rate (GFR, mL/min) as an indicator of CKD grading, and subjects should be stratified according to different degrees of renal function.

Conditions
Type2Diabetes
Being tested
PB119

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PB119Drug

    Each subject received only one dose of study drug during the study period. After completing the pre-dose procedure on the morning of the first day of the study, the subjects were given a subcutaneous injection of PB-119 0.3 mL (150 μg) once in the abdomen by the study nurse. The actual time of administration will be recorded in the subject's eCRF.

    Subjects should remain on an empty stomach for at least 10 hours prior to administration.

Study groups in NCT05328843
Study groupRoleWhat they receive
Group AExperimentalSubjects with mild renal insufficiency (CKD stage 2, GFR: 60-89 mL/min)
Receives: Drug: PB119
Group BExperimentalSubjects with moderate renal insufficiency (CKD stage 3, GFR: 30-59 mL/min)
Receives: Drug: PB119
Group CExperimentalSubjects with normal renal function (GFR: ≥ 90 and < 130 mL/min)
Receives: Drug: PB119

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary PK parameters: AUC0-inf

    Plasma will be collected at predose(-30 min ~ 0 min) and 2 h (Day1), 4 h (Day1), 9 h (Day1), 15 h (Day1), 24 h (Day2), 30 h (Day2), 36 h (Day2), 40 h (Day2), 48 h(Day3) ), 60 h(Day3), 72 h(Day40), 96 h(Day5), 120 h(Day6), 144 h(Day7), 192 h (Day9) , 240 h (Day11), 288 h (Day13), 336 h (Day15)last detectable plasma concentration

    Measured: Up to 336 h(Day15) post-dose

  2. Primary PK parameters: AUC0-t

    Plasma will be collected at predose(-30 min ~ 0 min) and 2 h (Day1), 4 h (Day1), 9 h (Day1), 15 h (Day1), 24 h (Day2), 30 h (Day2), 36 h (Day2), 40 h (Day2), 48 h(Day3) ), 60 h(Day3), 72 h(Day40), 96 h(Day5), 120 h(Day6), 144 h(Day7), 192 h (Day9) , 240 h (Day11), 288 h (Day13), 336 h (Day15)last detectable plasma concentration

    Measured: Up to 336 h(Day15) post-dose

  3. Primary PK parameters: Cmax

    Plasma will be collected at predose(-30 min ~ 0 min) and 2 h (Day1), 4 h (Day1), 9 h (Day1), 15 h (Day1), 24 h (Day2), 30 h (Day2), 36 h (Day2), 40 h (Day2), 48 h(Day3) ), 60 h(Day3), 72 h(Day40), 96 h(Day5), 120 h(Day6), 144 h(Day7), 192 h (Day9) , 240 h (Day11), 288 h (Day13), 336 h (Day15)last detectable plasma concentration

    Measured: Up to 336 h(Day15) post-dose

Secondary outcomes (7)

  1. Secondary PK parameters: Tmax

    Plasma will be collected at predose(-30 min ~ 0 min) and 2 h (Day1), 4 h (Day1), 9 h (Day1), 15 h (Day1), 24 h (Day2), 30 h (Day2), 36 h (Day2), 40 h (Day2), 48 h(Day3) ), 60 h(Day3), 72 h(Day40), 96 h(Day5), 120 h(Day6), 144 h(Day7), 192 h (Day9) , 240 h (Day11), 288 h (Day13), 336 h (Day15)last detectable plasma concentration

    Measured: Up to 336 h(Day15) post-dose

  2. Secondary PK parameters: T1/2

    Plasma will be collected at predose(-30 min ~ 0 min) and 2 h (Day1), 4 h (Day1), 9 h (Day1), 15 h (Day1), 24 h (Day2), 30 h (Day2), 36 h (Day2), 40 h (Day2), 48 h(Day3) ), 60 h(Day3), 72 h(Day40), 96 h(Day5), 120 h(Day6), 144 h(Day7), 192 h (Day9) , 240 h (Day11), 288 h (Day3), 336 h (Day15)last detectable plasma concentration

    Measured: Up to 336 h(Day15) post-dose

  3. Secondary PK parameters: Vz/F

    Plasma will be collected at predose(-30 min ~ 0 min) and 2 h (Day1), 4 h (Day1), 9 h (Day1), 15 h (Day1), 24 h (Day2), 30 h (Day2), 36 h (Day2), 40 h (Day2), 48 h(Day3) ), 60 h(Day3), 72 h(Day40), 96 h(Day5), 120 h(Day6), 144 h(Day7), 192 h (Day9) , 240 h (Day11), 288 h (Day3), 336 h (Day15)last detectable plasma concentration

    Measured: Up to 336 h(Day15) post-dose

  4. Secondary PK parameters: CL/F

    Plasma will be collected at predose(-30 min ~ 0 min) and 2 h (Day1), 4 h (Day1), 9 h (Day1), 15 h (Day1), 24 h (Day2), 30 h (Day2), 36 h (Day2), 40 h (Day2), 48 h(Day3) ), 60 h(Day3), 72 h(Day40), 96 h(Day5), 120 h(Day6), 144 h(Day7), 192 h (Day9) , 240 h (Day11), 288 h (Day3), 336 h (Day15)last detectable plasma concentration

    Measured: Up to 336 h(Day15) post-dose

  5. Secondary PK parameters: λz

    Plasma will be collected at predose(-30 min ~ 0 min) and 2 h (Day1), 4 h (Day1), 9 h (Day1), 15 h (Day1), 24 h (Day2), 30 h (Day2), 36 h (Day2), 40 h (Day2), 48 h(Day3) ), 60 h(Day3), 72 h(Day40), 96 h(Day5), 120 h(Day6), 144 h(Day7), 192 h (Day9) , 240 h (Day11), 288 h (Day3), 336 h (Day15)last detectable plasma concentration

    Measured: Up to 336 h(Day15) post-dose

  6. Secondary PK parameters: MRT

    Plasma will be collected at predose(-30 min ~ 0 min) and 2 h (Day1), 4 h (Day1), 9 h (Day1), 15 h (Day1), 24 h (Day2), 30 h (Day2), 36 h (Day2), 40 h (Day2), 48 h(Day3) ), 60 h(Day3), 72 h(Day40), 96 h(Day5), 120 h(Day6), 144 h(Day7), 192 h (Day9) , 240 h (Day11), 288 h (Day3), 336 h (Day15)last detectable plasma concentration

    Measured: Up to 336 h(Day15) post-dose

  7. Secondary PK parameters: AUC% extrapolated

    Plasma will be collected at predose(-30 min ~ 0 min) and 2 h (Day1), 4 h (Day1), 9 h (Day1), 15 h (Day1), 24 h (Day2), 30 h (Day2), 36 h (Day2), 40 h (Day2), 48 h(Day3) ), 60 h(Day3), 72 h(Day40), 96 h(Day5), 120 h(Day6), 144 h(Day7), 192 h (Day9) , 240 h (Day11), 288 h (Day3), 336 h (Day15)last detectable plasma concentration

    Measured: Up to 336 h(Day15) post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2022
  2. Study start1 May 2022 (estimated)
  3. Primary completion1 Oct 2022 (estimated)
  4. Study completion1 Oct 2022 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05328843
Sponsor's protocol ID
PB119109
Status last verified
Apr 2022
First submitted
5 Apr 2022
Last updated
14 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PB119 in people with Type2Diabetes, 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 15 inclusion and 31 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 14 Apr 2022. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ying Du, MD,PhD (+8618911797119, ying.du@pegbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary PK parameters: AUC0-inf (time frame: Up to 336 h(Day15) post-dose). The study lists 3 primary outcomes in all. 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 NCT05328843.

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 Apr 2022.

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