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A Clinical Study Investigating OM-85-IN Safety and Tolerability in Healthy Volunteers and Mild Allergic Asthma Patients

NCT06486662 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-03-03

No results posted yet for this study

Summary

This study will assess the safety and tolerability of OM-85-IN compared to placebo in healthy volunteers and mild asthmatic patients

Conditions

  • Allergic Asthma

Interventions

DRUG

OM-85-IN

Participants will receive a Single Ascending Dose (SAD): 1 day single dose treatment and Multiple Ascending Doses (MAD): 16 days multiple dose treatment of OM-85-IN

DRUG

Placebo

Participants will receive a Single Ascending Dose (SAD): 1 day single dose treatment and Multiple Ascending Doses (MAD): 16 days multiple dose treatment of Placebo

Sponsors & Collaborators

  • OM Pharma SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-06-14
Primary Completion
2025-02-19
Completion
2025-02-19

Countries

  • Germany

Study Locations

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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 NCT06486662 on ClinicalTrials.gov