Safety and Tolerability of SYNB1020-CP-001

Healthy Volunteer Clinical Trial

— SYNB1020CP001  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03179878
• Other study ID #: SYNB1020-CP-001
• Status: Completed
• Phase: Phase 1
• Start date: June 16, 2017
• Est. completion date: April 11, 2018

Study information

• Verified date: May 2021
• Source: Synlogic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

This Phase 1, dose-escalating, randomized, double-blinded study will evaluate SYNB1020 in placebo-controlled cohorts within the following 2 study parts:

Part 1: A single-ascending dose (SAD) study conducted in an inpatient setting over 6 days in healthy volunteer male and female subjects evaluated in up to 7 dose cohorts to identify the maximum tolerated dose (MTD) within the single dose range studied; and Part 2: A multiple-ascending dose (MAD) study conducted in an inpatient setting over 22 days in healthy volunteer male and female subjects evaluated in up to 4 dose cohorts that were proven tolerable in the SAD part of the study to identify the MTD of SYNB1020 within the multiple-dose range studied. Up to 48 subjects may be enrolled in this part of the study.

Subjects will be screened for eligibility within 30 days prior to enrollment, with evaluations of exercise habits, gastrointestinal (GI) signs and symptoms, fecal patterns (frequency, consistency), recent or current antibiotic exposure, and laboratory measurements. Eligible patients will be admitted to an inpatient facility for investigational product (IP) administration, safety monitoring, and collection of blood, urine, and fecal samples for pharmacokinetic and pharmacodynamic evaluations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 11, 2018
• Est. primary completion date: November 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer
• Urea Cycle Disorder
• Urea Cycle Disorders, Inborn

Intervention

Drug:
• Placebo
Placebo
• SYNB1020
Investigational Product

Locations

Country	Name	City	State
United States	Parexel	Brooklyn	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Synlogic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	GI tolerability measured using the Gastrointestinal Symptom Rating Scale (GSRS)	Will be measured using the Gastrointestinal Symptom Rating Scale (GSRS)	1 month of study entry
Secondary	SYNB1020 kinetics measured by qPCR fecal assays	Will be measured by qPCR fecal assays	3 months from study entry