Short Bowel SyndromePhase 1NCT06523101
A Study of PJ009 in Healthy Adult Volunteers
A Phase 1 study testing PJ009 in people with Short Bowel Syndrome, run by Chongqing Peg-Bio Biopharm Co., Ltd. at 1 site in China.
Trial summary
The main aim of this clinical trial is to assess the safety of PJ009 in healthy adult volunteers aged 18-45. The main questions it aims to answer are: Is PJ009 safe in healthy adult? Participants will Receive single dose of PJ009 or placebo according to weight, and then multiple doses daily for 7 days, Stay in… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- PJ009
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2023to 15 May 2023
- 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
- Voluntarily participate and sign the informed consent form;
- Healthy male or female subjects;
- Aged 18 to 45 years (inclusive), body weight ≥ 50kg; body mass index between 19.0 and 26.0 (inclusive), body mass index (BMI) = weight (kg)/height^2 (m^2);
- Female subjects of childbearing age with negative serum pregnancy test results;
- Eligible subjects of fertility must agree to use effective contraceptive measures or abstain from sex during the study and within 6 months after the study;
- Be able to understand and comply with the requirements of the protocol and expected to complete the entire study process.
Who cannot join
- History of allergic diseases (including but not limited to asthma, urticaria, allergic rhinitis), drug allergy, or allergy to the ingredients of the investigational drug;
- Used any drugs (including prescription drugs, over-the-counter drugs and Chinese herbal medicines) within 4 weeks before enrollment, except for external drugs that are not absorbed by the body; or used drugs known to cause significant damage to a certain organ within 12 weeks before enrollment;
- History of any serious disease, including but not limited to digestive system, cardiovascular system, respiratory system, urinary system, musculoskeletal system, endocrine system, neuropsychiatric system, blood system, immune system diseases and metabolic abnormalities, or neurological or mental disorders, such as epilepsy and dementia;
- History of congenital hemolytic hyperbilirubinemia;
- History of gallstones or gastrointestinal surgery;
- History of colorectal cancer;
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- History of gastrointestinal diseases, such as malabsorption, Crohn's disease, etc;
- History of rash or dermatitis;
- The laboratory and auxiliary examination results meet any of the following conditions:
- Abnormal electrocardiogram with clinical significance determined by the investigator;
- Abnormal vital signs with clinical significance determined by the investigator;
- Positive results of HIV-Ab, HCV-Ab, HBsAg or syphilis test;
- Abnormal results of laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function) with clinical significance;
- Positive results of drug abuse or alcohol test;
- Abnormal results of chest X-ray (anterior) with clinical significance determined by the investigator;
- History of donating blood ≥ 200 mL within 12 weeks before enrollment, or plan to donate blood during the study;
- History of major surgery within 12 weeks before enrollment;
- History of alcohol abuse within 6 months before enrollment, that is, drinking more than 14 units of alcohol per week (1 unit = 12 ounces or 360 mL of beer, 1.5 ounces or 45 mL of liquor with an alcohol content of 40%, 5 ounces or 150 mL wine);
- Smoke more than 5 cigarettes a day within 6 months before enrollment;
- Participated in other clinical trials within 12 weeks before enrollment, or used similar drugs of the investigational drug;
- Cannot tolerate venipuncture blood collection or have a history of needle or blood fainting;
- Lactating, pregnant, or planning to become pregnant or conceive in the near future;
- Poor compliance as assessed by the investigator;
- The investigator believes the subject is unsuitable for participating in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PJ009 in Healthy Adult Volunteers
The main aim of this clinical trial is to assess the safety of PJ009 in healthy adult volunteers aged 18-45. The main questions it aims to answer are:
- Is PJ009 safe in healthy adult? Participants will
- Receive single dose of PJ009 or placebo according to weight, and then multiple doses daily for 7 days,
- Stay in hospital for assessment.
Read the detailed description
This is a single center, randomized, double-blind, placebo-controlled phase 1 clinical study, aiming to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PJ009 in healthy adult volunteers.
- Conditions
- Short Bowel Syndrome
- Being tested
- PJ009, Placebo
- Medical subject headings
- Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PJ009Drug
Also called Glucagon-like Peptide-2 (GLP-2) analogue
Six participants in each dose level will be randomized to receive a single dose and/or multiple doses of PJ009 in a double-blind fashion.
PlaceboDrug
Two participants in each dose level will be randomized to receive placebo in a double-blind fashion.
| Study group | Role | What they receive |
|---|---|---|
| PJ009 group | Experimental | Participants will receive a single dose of PJ009 on day1, and then multiple doses of PJ009 once daily for 7 days (day5-11). Three dose levels will be evaluated. subcutaneous injection Receives: Drug: PJ009 |
| PJ009 Placebo group | Placebo comparator | Participants will receive a single dose of PJ009 placebo on day1, and then once daily for 7 days (day5-11). subcutaneous injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related Adverse Events
Number of participants with treatment-related adverse events during the study will be collected and the percentage of adverse events (AEs) of different grades as assessed by CTCAE v5.0 will be assessed.
Measured: Up to 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start28 Feb 2023
- Primary completion15 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Bowel SyndromeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Peg-Bio Biopharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruigang Hou, Principal investigator, Second Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523101
- Sponsor's protocol ID
- CQPJ-PJ009-001
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PJ009 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT06523101
- Acronym / sponsor ID
- CQPJ-PJ009-001
- Conditions
- Short Bowel Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chongqing Peg-Bio Biopharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 26 Jul 2024 (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.
The main aim of this clinical trial is to assess the safety of PJ009 in healthy adult volunteers aged 18-45. The main questions it aims to answer are:
- Is PJ009 safe in healthy adult? Participants will
- Receive single dose of PJ009 or placebo according to weight, and then multiple doses daily for 7 days,
- Stay in hospital for assessment.
Detailed description
This is a single center, randomized, double-blind, placebo-controlled phase 1 clinical study, aiming to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PJ009 in healthy adult volunteers.
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 |
|---|---|---|
| PJ009 group | Experimental | Drug: PJ009Participants will receive a single dose of PJ009 on day1, and then multiple doses of PJ009 once daily for 7 days (day5-11). Three dose levels will be evaluated. subcutaneous injection |
| PJ009 Placebo group | Placebo comparator | Drug: PlaceboParticipants will receive a single dose of PJ009 placebo on day1, and then once daily for 7 days (day5-11). subcutaneous injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Voluntarily participate and sign the informed consent form;
- Healthy male or female subjects;
- Aged 18 to 45 years (inclusive), body weight ≥ 50kg; body mass index between 19.0 and 26.0 (inclusive), body mass index (BMI) = weight (kg)/height^2 (m^2);
- Female subjects of childbearing age with negative serum pregnancy test results;
- Eligible subjects of fertility must agree to use effective contraceptive measures or abstain from sex during the study and within 6 months after the study;
Key exclusion criteria (24 listed)
- History of allergic diseases (including but not limited to asthma, urticaria, allergic rhinitis), drug allergy, or allergy to the ingredients of the investigational drug;
- Used any drugs (including prescription drugs, over-the-counter drugs and Chinese herbal medicines) within 4 weeks before enrollment, except for external drugs that are not absorbed by the body; or used drugs known to cause significant damage to a certain organ within 12 weeks before enrollment;
- History of any serious disease, including but not limited to digestive system, cardiovascular system, respiratory system, urinary system, musculoskeletal system, endocrine system, neuropsychiatric system, blood system, immune system diseases and metabolic abnormalities, or neurological or mental disorders, such as epilepsy and dementia;
- History of congenital hemolytic hyperbilirubinemia;
- History of gallstones or gastrointestinal surgery;
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 |
|---|---|---|
| PJ009Also: Glucagon-like Peptide-2 (GLP-2) analogueSix participants in each dose level will be randomized to receive a single dose and/or multiple doses of PJ009 in a double-blind fashion. | Drug | PJ009 group |
| PlaceboTwo participants in each dose level will be randomized to receive placebo in a double-blind fashion. | Drug | PJ009 Placebo group |
Primary outcome
Treatment-related Adverse Events
Time frame: Up to 18 days
Number of participants with treatment-related adverse events during the study will be collected and the percentage of adverse events (AEs) of different grades as assessed by CTCAE v5.0 will be assessed.
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 29 Jul 2024.
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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.
Ruigang Hou principal investigator
Second Hospital of Shanxi Medical 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 PJ009 in people with Short Bowel Syndrome, run by Chongqing Peg-Bio Biopharm 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 6 inclusion and 24 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 29 Jul 2024. 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?
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?
Treatment-related Adverse Events (time frame: Up to 18 days). 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 29 Jul 2024.