Safety and Tolerability of SYNB1020-CP-001
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 4/26/2018 |
| Start Date: | June 16, 2017 |
| End Date: | April 11, 2018 |
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
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
Double-blinded, Placebo-controlled Study of SYNB1020 in Healthy Adult Volunteers to Evaluate
Safety, Tolerability, Dosing, and Pharmacodynamics
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.
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.
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
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