Current partner codePEPTIDESDE
NCT07704047·Phase 2·INTERVENTIONAL

A Clinical Study of FT1 in Patients With Short Bowel Syndrome

Status

Recruiting

Phase

Phase 2

Enrollment

8

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

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.

Interventions

Treatment arms and agents.

DRUG

FT1

FT1 treatment, once weekly for 5 weeks

DRUG

Placebo

Placebo, once weekly for 5 weeks

Timeline

From registration to results.

  1. First posted

    Jul 15, 2026

  2. Study start

    Aug 30, 2026

  3. Primary completion

    Apr 15, 2027

  4. Study completion

    Apr 15, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jul 15, 2026

Outcomes

What the study measures.

Primary outcomes

Treatment-related Adverse Events

Time frame · From the first administration to study completion, appropriately 5 months.

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.

Changes in fecal wet weight from baseline to the end of treatment

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)

The difference in changes in fecal wet weight in the 72-hour metabolic balance study after treatment compared to baseline

Secondary outcomes

Changes in urine volume from baseline to the end of treatment

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)

The difference in changes in urine volume in the 72-hour metabolic balance study after treatment compared to baseline

The Area Under the Curve from dosing to the time of the last measured concentration (AUC0-t)

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)

Pharmacokinetic parameter

Maximum plasma concentration (Cmax)

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)

Pharmacokinetic parameter

Changes in L-citrulline levels in plasma

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)

Pharmacodynamic parameter

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * 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; * During the trial period, there were no plans to perform any major abdominal surgeries (such as intestinal resection exceeding 10% or surgeries that alter intestinal anatomy, such as stoma surgery); * During the baseline metabolic balance study, the average daily fecal wet rearrangement amount was ≥ 800g; Exclusion Criteria: * 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); * History of gallstones in the past 3 years, except for those who have undergone cholecystectomy for gallstones; Acute cholecystitis or biliary obstruction related diseases that have not been treated within the previous month or during the screening period; * IBD patients with active inflammatory bowel disease (IBD), or requiring increased or altered immunosuppressive therapy in the past 3 months, or receiving biologic therapy in the past 6 months; * Occurrence of central venous catheter-related bloodstream infections within 2 months prior to and during the screening period; * Patients diagnosed with decompensated heart failure (NYHA grade III or above) and/or unstable angina and/or myocardial infarction from 6 months prior to screening until the first administration of the study drug; * Screening for individuals with rectal bleeding within the first 3 months; * Individuals with absorption instability caused by cystic fibrosis, untreated megacolon disease, or known DNA abnormalities (such as familial adenomatous polyposis, Fanconi syndrome); * Serious active, uncontrolled, untreated, acute onset systemic diseases (such as cardiovascular, respiratory, renal, infectious, endocrine, liver or central nervous system, etc.); * Pregnant or breastfeeding women. * The investigator believes the subject is unsuitable for participating in this clinical study.

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

General Hospital of Eastern Theater Command

Nanjing, Jiangsu, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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