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

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.

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

• 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.

United States
PPD, part of Thermo Fisher Scientific
Contact Information
Michael Baez
1 512 747 4601
Roberto Vincent, MS
Time Frame
Start Date: March 29, 2022
Estimated Completion Date: October 2022
Target number of participants: 10
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
Leads: Synlogic

This content was sourced from clinicaltrials.gov