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Safety and Tolerability of SYNB1934 in Healthy Adult Volunteers

NCT04984525 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2022-05-18

No results posted yet for this study

Summary

This Phase 1, first-in-human, multiple dose-escalation, randomized, double-blinded, placebo-controlled study is evaluating SYNB1934 in healthy volunteers (HV). Eligible subjects receive investigational product (IP) and undergo safety monitoring, evaluations, and subsequent follow-up after IP administration.

Conditions

  • Healthy

Interventions

DRUG

SYNB1934

SYNB1934 is formulated as a nonsterile solution intended for oral administration

DRUG

SYNB1618

SYNB1618 is formulated as a nonsterile solution intended for oral administration

Sponsors & Collaborators

  • Synlogic

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-02
Primary Completion
2021-12-10
Completion
2021-12-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04984525 on ClinicalTrials.gov