Safety and Tolerability of SYNB1020-CP-001

• Register: ClinicalTrials.gov
• Last refreshed on: 24 May 2021
• Main ID: NCT03179878
• Date of registration: 06/06/2017
• Prospective Registration: Yes
• Primary sponsor: Synlogic
• Public title: Safety and Tolerability of SYNB1020-CP-001 SYNB1020CP001
• Scientific title: A Phase 1, First-in-human, Oral Single and Multiple Dose-Escalation, Randomized, Double-blinded, Placebo-controlled Study of SYNB1020 in Healthy Adult Volunteers to Evaluate Safety, Tolerability, Dosing, and Pharmacodynamics
• Date of first enrolment: June 16, 2017
• Target sample size: 52
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03179878
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

United States

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Age 18 to 64 years

- Healthy volunteer Males and Females; Females must be of non childbearing potential

- Able and willing to complete informed consent process

- Available for and agree to all study procedures

- Screening Labs within normal range

Key Exclusion Criteria:

- Acute or chronic medical, surgical, psychiatric, social or laboratory abnormality

- Body mass index < 18.5 or = 30 kg/m2

- Intolerance of or allergic reaction to E. coli Nissle or any of the ingredients in
SYNB1020 or placebo formulations; allergies to common foods (e.g., eggs, milk, soy,
nuts).

- Prior participation in a study with SYNB1020

- Evidence or history of clinical signification hematological, renal, endocrine,
pulmonary, GI cardiovascular, hepatic, psychiatric, neurologic or allergic disease

- Personal or family history of UCD



Age minimum: 18 Years
Age maximum: 64 Years
Gender: All

Health Condition(s) or Problem(s) studied

Urea Cycle Disorder

Healthy Volunteer

Intervention(s)

Drug: Placebo

Drug: SYNB1020

Primary Outcome(s)

Incidence of Treatment-Emergent Adverse Events, Laboratory Assessments and ECGs to measure Safety and Tolerability of SYNB1020 [Time Frame: 3 months from study entry]

Secondary Outcome(s)

SYNB1020 kinetics measured by qPCR fecal assays [Time Frame: 3 months from study entry]

GI tolerability measured using the Gastrointestinal Symptom Rating Scale (GSRS) [Time Frame: 1 month of study entry]

Secondary ID(s)

SYNB1020-CP-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors