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A Phase 1b Study of STMC-103H in Multi-Sensitized Allergic Subjects Who Are Otherwise Healthy

NCT03819881 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-01-29

No results posted yet for this study

Summary

The primary objective of this study is to assess the safety and tolerability of STMC-103H compared to placebo in allergic subjects who are otherwise healthy.

Conditions

  • Atopic Immunoglobulin E-Mediated Allergic Disorder

Interventions

BIOLOGICAL

STMC-103H

Live bacterial product

BIOLOGICAL

Placebo

Inactive placebo substance

Sponsors & Collaborators

  • Integrium

    collaborator INDUSTRY

  • Siolta Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Joel Neutel, MD · Orange County Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
2 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-10
Primary Completion
2019-11-30
Completion
2019-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03819881 on ClinicalTrials.gov