NB1001 in Short Bowel Syndrome

Condition: Short bowel syndrome

Eligibility

Key Inclusion Criteria

  • 18-75 years old
  • Short bowel syndrome secondary to surgical resection of small intestine, with or without an intact colon
  • Female participants must be postmenopausal (at least 2 years), surgically sterile, or agree to use an acceptable form of birth control. If oral contraceptives are used, must have been on a stable dose for ≥6 months.

Key Exclusion Criteria

  • Positive results on HIV, hepatitis or drug screens
  • Pregnancy or lactation
  • Body mass index <18 or >30kg/m2

Full Study Name

A Phase I/II, Proof of Concept, Open-Label, Repeat-Dose, Dose Escalation Study of NB1001 in Adult Patients with Short Bowel Syndrome (IRB no. 00000605)

Summary
This study focuses on individuals who have been diagnosed with short bowel syndrome (SBS) secondary to surgical resection (removal) of the small intestine. The purpose of the study is determine whether an investigational drug called NB1001 will improve the symptoms of SBS. Researchers will evaluate the safety and tolerability of NB1001, determine whether urine output changes over a 48-hour period after taking the drug, and assess the potential to reduce the overall need for intravenous fluids or intravenous nutrition. Participants will be assigned to one of three study groups. Group 1 will receive 50 mg of NB1001; Group 2 will receive 100 mg of NB1001; and Group 3 will receive 150 mg of NB1001.

Principal Investigator
Shirley Paski, MD

Contact
Medically Associated Science and Technology (MAST) Program Office
Phone: 310-423-0617
E-mail: groupmedicinemastclinical@cshs.org or mastprogram@cshs.org