Safety and Tolerability of SYNB1020-CP-001

• Status: Completed
• Trial end date: 2018-04-11
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Synlogic

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