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

NCT06486662 | Completed Phase 1 DMC

• 2 other identifiers: BV-2022/112022-503053-19-00
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with treatment-emergent adverse events (TEAEs) (including clinically relevant findings from nasal inspection)

  28 days

Secondary Outcomes (6)

• Part II : Mean difference of Total Nasal Symptom Score (TNSS points) before and after treatment defined as the arithmetic mean of TNSS collected from pre-Nasal Allergen Challenge (NAC) to 6 hours post-NAC

  28 days

• Part II : Area under the curve (AUC)0-6 hours of Total Nasal Symptom Score (TNSS points) after NAC before and after treatment

  28 days

• Part II : Mean difference of nasal flow by rhinomanometry (Pascal) before and after treatment defined as the arithmetic mean of TNSS collected from pre-Nasal Allergen Challenge (NAC) to 6 hours post-NAC

  28 days

• Part II : Area under the curve (AUC)0-6 of nasal flow by rhinomanometry (Pascal) after NAC before and after treatment

  28 days

• Part II : Mean difference in fractional exhaled nitric oxide (FeNO) before and after treatment and NAC

  28 days

Study Arms (8)

Part I -Cohort 1

EXPERIMENTAL

OM-85-IN low Dose

Drug: OM-85-IN

Part I -Cohort 1 Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Part I -Cohort 2

EXPERIMENTAL

OM-85-IN medium dose

Drug: OM-85-IN

Part I -Cohort 2 Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Part I -Cohort 3

EXPERIMENTAL

OM-85-IN high dose

Drug: OM-85-IN

Part I -Cohort 3 Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Part II -Cohort 4

EXPERIMENTAL

OM-85-IN dose

Drug: OM-85-IN

Part II -Cohort 4 Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

OM-85-IN DRUG

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

Part I -Cohort 1; Part I -Cohort 2; Part I -Cohort 3; Part II -Cohort 4

Placebo DRUG

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

Part I -Cohort 1 Placebo; Part I -Cohort 2 Placebo; Part I -Cohort 3 Placebo; Part II -Cohort 4 Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Not pregnant, as confirmed by pregnancy test, and not breastfeeding.
• Of non-childbearing potential, or
• Of childbearing potential and using a highly effective method of contraception .
• Body mass index (BMI) ≥18 and ≤32 kg/m2.
• Part II : History of mild asthma that is well controlled with Step 1 treatment according to GINA guidelines 2023 for at least 12 months prior to the Screening Visit, i.e., a history of respiratory symptoms such as wheeze, shortness of breath, chest tightness, cough, and limitation of airflow induced by aeroallergens.
• Part II: Forced Expiratory Volume in the first second (FEV1) ≥80% of predicted at Screening Visit.
• Part II : Positive skin prick test to common aeroallergens such as tree, weed, grass or house dust mites within 12 months prior to the Screening Visit
• Part II : Production of adequate sputum with ≥2 x 105 total non-squamous cells within 12 months to 2 weeks prior to V1A (Day -8)
• Part II : Positive reaction to Nasal Allergen Challenge (NAC) within 12 months to 2 weeks prior to baseline

You may not qualify if:

• Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs, lung function or electrocardiogram (ECG) at Screening Visit, which, in the opinion of the Investigator, may either put the subject at risk because ofvparticipation in the study or may influence the results of the study, or the subject's ability to participate in the study."
• Use of prohibited medication prior to study enrolment
• Part II - Long-term, daily treatment with inhaled corticosteroids.
• Part II - Exacerbation of asthma defined according to the GINA guideline 2023 as a progressive increase in symptoms of shortness of breath, cough, wheezing or chest tightness and progressive decrease in lung function, i.e., they represent a change from the patient's usual status that is sufficient to require treatment changes within 1 month prior to the Screening Visit.
• Part II - Concomitant allergies to seasonal aeroallergens which are anticipated to be or become active during study participation.
• Known allergy to IMP active substance and/or excipients or the challenge agent components.
• Specific immunotherapy in the past 3 years before Baseline, ongoing treatment with any specific immunotherapy or plan to receive such treatment during study participation.
• Previous or ongoing treatment with other bacterial lysates and/or probiotics (dietary supplements, medicinal products and/or other health products) within 30 days before Baseline.
• Patients with pathological skin modifications in the test area (e.g., acute or chronic eczema or skin infections), with disturbed skin reactivity (e.g., hyperkeratosis, ichthyosis, urticaria factitial), or with acute, generalized hypersensitivity reactions.
• Participation in any other clinical study within 30 days prior to Screening.
• Past or present disease, which as judged by the Investigator, may affect the outcome of this study.
• Positive serology test for hepatitis B surface antigen (HBsAg), hepatitis B core antibodies, hepatitis C virus antibodies (HCV-Ab) or human immunodeficiency virus (HIV) antibody at Screening Visit
• History or presence of clinically significant hypertension
• History of anaphylactic shock, generalised exanthema, angioedema or hypotension caused by the allergen used for NAC, or any medicinal product in the past.
• History of drug or alcohol abuse in the past 12 months.

Sponsors & Collaborators

• OM Pharma SA: lead

Study Sites (1)

The Fraunhofer Institute For Toxicology And Experimental Medicine ITEM

Hanover, 30625, Germany

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 3, 2024
• Study Start: June 14, 2024
• Primary Completion: February 19, 2025
• Study Completion: February 19, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)