A Double-Blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacodynamics of SYNB8802v1 in Subjects With History of Gastric Bypass Surgery or Short-bowel Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

Study SYNB8802-CP-002 is designed to assess safety, tolerability, and oxalate lowering, in subjects with a history of gastric bypass surgery or short-bowel syndrome. In addition, this study will explore other PD effects relative to baseline as well as predictors of efficacy and tolerability.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 74
Healthy Volunteers: No
View:

• Age ≥ 18 to ≤ 74 years.

• Able and willing to voluntarily complete the informed consent process.

• Available for, and agree to, all study procedures, including fixed diet, feces, urine, and blood

• collection, follow-up visits, and compliance with all study procedures.

• History of gastric bypass surgery (at least 12 months prior to Day 1) or short-bowel

• syndrome.

• If taking probiotic supplements (enriched foods excluded), has been on a stable, well tolerated dose for at least 2 weeks prior to Day 1.

• Women of childbearing potential must have a negative pregnancy test (human chorionic

• gonadotropin) at screening and at baseline prior to the start of IMP.

• Screening laboratory evaluations (e.g., chemistry panel, complete blood count with

• differential, prothrombin time, urinalysis) and electrocardiogram (ECG) must be within

• normal limits or judged not to be clinically significant by the investigator. Subjects with

• known diabetes should be well controlled and have an A1c of ≤ 8% within 3 months prior to Day 1.

• Agree to abstain from tobacco/nicotine use for the duration of the inpatient stay.

• Subjects who are HIV positive, on therapy with normal CD4 counts and undetectable viral loads, can be included.

Locations
United States
Texas
PPD, part of Thermo Fisher Scientific
Recruiting
Austin
Contact Information
Primary
Michael Baez
Michael.Baez@ppd.com
1 512 747 4601
Backup
Roberto Vincent, MS
roberto.vincent@synlogicTX.com
7813635032
Time Frame
Start Date: March 29, 2022
Estimated Completion Date: October 2022
Participants
Target number of participants: 10
Treatments
Experimental: SYNB8802v1
Dose ramp to 1 × 1011 QD and then dose ramp to 3 × 1011 TID SYNB8802v1 live cells
Placebo Comparator: Placebo
Placebo will be administered during the dose ramp such that all subjects receive IMP dosing TID
Sponsors
Leads: Synlogic

This content was sourced from clinicaltrials.gov