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

Synlogic

Status and phase

Completed

Phase 1

Conditions

Urea Cycle Disorder

Healthy Volunteer

Treatments

Drug: SYNB1020

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03179878

SYNB1020-CP-001

Details and patient eligibility

About

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

Full 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.

Enrollment

52 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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