SYNB1020CP001: Safety and Tolerability of SYNB1020-CP-001

• Sponsor: Synlogic (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03179878
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.8
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer; Urea Cycle Disorder	Drug: Placebo; Drug: SYNB1020	Phase 1

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, Double-blinded, Placebo controlledRandomized, Double-blinded, Placebo controlled
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double Blind
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 16, 2017
• Actual Primary Completion Date: Nov 2, 2017
• Actual Study Completion Date: Apr 11, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SYNB1020 SYNB1020	Drug: SYNB1020; Investigational Product
Placebo Comparator: Placebo 100 mL masking solution	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

   Will be measured using the Gastrointestinal Symptom Rating Scale (GSRS)

2. SYNB1020 kinetics measured by qPCR fecal assays [3 months from study entry]

   Will be measured by qPCR fecal assays

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parexel	Brooklyn	Maryland	United States	21225

Sponsors and Collaborators

• Synlogic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Synlogic
• ClinicalTrials.gov Identifier: NCT03179878
• Other Study ID Numbers: SYNB1020-CP-001
• First Posted: Jun 7, 2017
• Last Update Posted: May 12, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urea Cycle Disorders, Inborn

Study Results

No Results Posted as of May 12, 2021