Safety and Tolerability of SYNB1020-CP-001

NCT03179878 | Completed Phase 1 FDA Drug

• 1 other identifier: SYNB1020-CP-001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy Volunteer; Urea Cycle Disorder

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events, Laboratory Assessments and ECGs to measure Safety and Tolerability of SYNB1020

  Will be measured by assessing nature and frequency of AEs, Laboratory Assessments, and ECGs

  3 months from study entry

Secondary Outcomes (2)

• GI tolerability measured using the Gastrointestinal Symptom Rating Scale (GSRS)

  1 month of study entry

• SYNB1020 kinetics measured by qPCR fecal assays

  3 months from study entry

Study Arms (2)

SYNB1020

EXPERIMENTAL

SYNB1020

Drug: SYNB1020

Placebo

PLACEBO COMPARATOR

100 mL masking solution

Drug: Placebo

Interventions

Placebo DRUG

Placebo

Placebo

SYNB1020 DRUG

Investigational Product

SYNB1020

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Synlogic: lead

Study Sites (1)

Parexel

Brooklyn, Maryland, 21225, United States

Location

MeSH Terms

Conditions

Urea Cycle Disorders, Inborn

Condition Hierarchy (Ancestors)

Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-blinded, Placebo controlled

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 7, 2017
• Study Start: June 16, 2017
• Primary Completion: November 2, 2017
• Study Completion: April 11, 2018
• Last Updated: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)