A Clinical Study of FT1 in Patients With Short Bowel Syndrome
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChongqing Peg-Bio Biopharm Co., Ltd.
About this trial
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
* Receive multiple injections of FT1 or placebo according to weight. * Visit the clinic for assessment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years, male or female.
SBS secondary to surgical resection of the small intestine, screened for at least 12 months after pre intestinal resection surgery;
Stable weight before screening; For patients requiring parenteral support (PS), PS volume remained stable (with changes in volume or energy content<25%) within 14 days prior to randomization;
Willing to undergo colonoscopy and remove polyps assessed by researchers to be at risk of cancer;
Disqualifiers
Having undergone major abdominal surgery (such as intestinal resection exceeding 10%) within the past 6 months prior to screening;
History of clinically significant intestinal adhesions and/or chronic abdominal pain;
History of persistent radiation enteritis, celiac disease, refractory diarrhea, etc;
Patients with malignant tumors within the past 5 years (excluding fully treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, local prostate cancer after radical surgery, and ductal carcinoma in situ of the breast after radical surgery);
Trial design
Design model
Crossover
Treatments tested in this trial
FT1
DrugFT1 treatment, once weekly for 5 weeks
Placebo
DrugPlacebo, once weekly for 5 weeks
Treatment groups
8 Participants
are divided into 2 treatment groupsGroup A: FT1Experimental treatment 1 intervention
Group B: FT1 PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From the first administration to study completion, appropriately 5 months.2
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
Time frame
At the end of the second cycle (each cycle is 5 weeks, with a washout period of at least 6 weeks between two cycles)Secondary outcomes
1
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
Time frame
At the end of the second cycle (each cycle is 5 weeks, with a washout period of at least 6 weeks between two cycles)2
The Area Under the Curve from dosing to the time of the last measured concentration (AUC0-t)
Pharmacokinetic parameter
Time frame
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)3
Maximum plasma concentration (Cmax)
Pharmacokinetic parameter
Time frame
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)4
Changes in L-citrulline levels in plasma
Pharmacodynamic parameter
Time frame
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov