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The goal of this clinical trial is to learn if FT1 is safe and works to treat short bowel syndrome (SBS) in adults. It will also learn about the PK/PD profile of FT1.
Researchers will compare FT1 to a placebo (a look-alike substance that contains no drug) to see if FT1 is safe and effective in patients with SBS.
Participants will
In this placebo-controlled, double-blind, randomized, crossover phase 2 trial, 8 adult SBS patients are treated with once-weekly FT1 or placebo (1:1) for 5 weeks, followed by a washout period of at least 6 weeks, and then the alternate treatment for a further 5 weeks.
Efficacy is evaluated through a 72 hour metabolic balance study conducted at baseline and at the end of each treatment cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FT1 | Experimental | FT1 will be administered subcutaneously once a week for 5 weeks during each treatment cycle. |
|
| FT1 Placebo | Placebo Comparator | FT1 Placebo will be administered subcutaneously once a week for 5 weeks during each treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FT1 | Drug | FT1 treatment, once weekly for 5 weeks |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related Adverse Events | To evaluate the adverse events as characterized by type, frequency, severity as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 6.0, timing, seriousness, and relationship to study therapy after administration. | From the first administration to study completion, appropriately 5 months. |
| Changes in fecal wet weight from baseline to the end of treatment | The difference in changes in fecal wet weight in the 72-hour metabolic balance study after treatment compared to baseline | At the end of the second cycle (each cycle is 5 weeks, with a washout period of at least 6 weeks between two cycles) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in urine volume from baseline to the end of treatment | The difference in changes in urine volume in the 72-hour metabolic balance study after treatment compared to baseline | At the end of the second cycle (each cycle is 5 weeks, with a washout period of at least 6 weeks between two cycles) |
| The Area Under the Curve from dosing to the time of the last measured concentration (AUC0-t) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Sun | Contact | +86-13983367811 | sunj@pegbiocq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Eastern Theater Command | Recruiting | Nanjing | Jiangsu | 210002 | 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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In this placebo-controlled, double-blind, randomized, crossover trial, SBS patients are treated with once-weekly FT1 or placebo (1:1) for 5 weeks, followed by a washout period of at least 6 weeks, and then the alternate treatment for a further 5 weeks.
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| Drug |
Placebo, once weekly for 5 weeks |
|
Pharmacokinetic parameter |
| Up to 8 days, from Day 29 (the last dose administration) to Day 36 (7 days after the last dose) in each treatment cycle (each cycle is 5 weeks) |
| Maximum plasma concentration (Cmax) | Pharmacokinetic parameter | Up to 8 days, from Day 29 (the last dose administration) to Day 36 (7 days after the last dose) in each treatment cycle (each cycle is 5 weeks) |
| Changes in L-citrulline levels in plasma | Pharmacodynamic parameter | From Day 1 of the first cycle to the end of the second cycle (each cycle is 5 weeks, with a washout period of at least 6 weeks between two cycles) |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |