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Metabolic Balance Study of FE203799 in Patients With SBS With Intestinal Insufficiency

NCT03408132 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-10-24

No results posted yet for this study

Summary

This is a repeated dose, open label trial investigating safety, efficacy, PD and PK of FE 203799 in 8 patients with SBS. The patients will receive a subcutaneous (SC) dose of 5 mg FE 203799 once weekly for 4 consecutive weeks, and efficacy parameters and PK will be assessed after the fourth dose. Safety follow up assessments will be performed 4-6 weeks after the last dose.

Conditions

  • SBS - Short Bowel Syndrome

Interventions

DRUG

FE203799

FE203799 5 mg subcutaneous once weekly

Sponsors & Collaborators

  • VectivBio AG

    collaborator INDUSTRY

  • GlyPharma Therapeutics

    lead INDUSTRY

Principal Investigators

  • Tomasz Masior · VectivBio AG

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-02
Primary Completion
2019-10-28
Completion
2019-10-28

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03408132 on ClinicalTrials.gov