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
Qualifiers
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
Treatments tested in this trial
- FT1
- Placebo
Treatment groups
8 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov