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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PJ009 | Drug | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 18 days |
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Inclusion Criteria:
Exclusion Criteria:
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;
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Ruigang Hou | Second Hospital of Shanxi Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Shanxi Medical University | Taiyuan | Shanxi | 030001 | China |
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| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Placebo | Drug | Two participants in each dose level will be randomized to receive placebo in a double-blind fashion. |
|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |