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Safety and Tolerability of SYNB1020-CP-001 (SYNB1020CP001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03179878
Recruitment Status : Completed
First Posted : June 7, 2017
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Synlogic

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, 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 : June 16, 2017
Actual Primary Completion Date : November 2, 2017
Actual Study Completion Date : April 11, 2018


Arm Intervention/treatment
Experimental: SYNB1020
SYNB1020
Drug: SYNB1020
Investigational Product

Placebo Comparator: Placebo
100 mL masking solution
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events, Laboratory Assessments and ECGs to measure Safety and Tolerability of SYNB1020 [ Time Frame: 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) [ Time Frame: 1 month of study entry ]
    Will be measured using the Gastrointestinal Symptom Rating Scale (GSRS)

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179878


Locations
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United States, Maryland
Parexel
Brooklyn, Maryland, United States, 21225
Sponsors and Collaborators
Synlogic

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Responsible Party: Synlogic
ClinicalTrials.gov Identifier: NCT03179878     History of Changes
Other Study ID Numbers: SYNB1020-CP-001
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Urea Cycle Disorders, Inborn
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
Metabolic Diseases