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Study Evaluating Safety of Ragweed Mix Given by Intralymphatic Node Injections

NCT03038971 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2018-02-26

No results posted yet for this study

Summary

A safety study conducted on subjects ≥16 years old evaluating the safety of 4 intralymphatic injections of 2 different dose levels of the investigational short and tall ragweed product. Biomarkers will be assessed at baseline and at multiple time points post-treatment.

Conditions

  • Allergic Conjunctivitis
  • Allergic Rhinitis

Interventions

BIOLOGICAL

Dose Level 1

Short and Tall Ragweed Mix

BIOLOGICAL

Dose Level 2

Short and Tall Ragweed Mix

BIOLOGICAL

Placebo

Saline with 0.4% Phenol

Sponsors & Collaborators

  • ORA, Inc.

    collaborator INDUSTRY

  • Woodmont Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Emily Schoemmell · ORA, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-30
Primary Completion
2017-04-29
Completion
2017-04-29
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 NCT03038971 on ClinicalTrials.gov