Safety, Tolerability and Immune Effects of the Nasal Foralumab in Healthy Human Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-12

Study Completion Date

2020-11-09

Brief Summary

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The goal is to establish the safety of administration of nasal foralumab to healthy volunteers in escalating doses to determine the dose at which immune effects are observed. Patients will receive doses for 5 consecutive days and have a follow-up period.

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Detailed Description

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This was a randomized, double blind phase 1 dose escalation study evaluating 3 dose levels of foralumab via intranasal administration from single-dose vials. The rationale behind the proposed research was to establish an immunologically active dose of foralumab given by the nasal route. Given that foralumab has never been administered by the nasal route to humans, this was a safety and dose finding study. Each dose group was observed until Day 7 to assess safety before moving to the next higher dose. This study also helped determine the dose at which immune effects (induction of regulatory T cells and changes in cytokine profiles of immune cells) were observed in subjects treated with foralumab.

Conditions

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Safety Tolerability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

This is a randomized, double blind Phase I dose escalation study evaluating three dose levels of Foralumab via intranasal administration from single-dose vials. Each dose group will complete 7 days of assessment and be evaluated for safety before the study moves to the next dosing level. After the first 9 subjects complete their Day 8 visit, the next 9 subjects will be enrolled and receive 50 ug of nasal Foralumab or placebo once daily for 5 days; after the second group completes visit Day 8, the third dose group will be enrolled and receive 250 ug of nasal Foralumab/placebo once daily for 5 days.

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

The treating physician and subjects will be blinded to treatment. The BWH IDS pharmacy will have the treatment code assignments.

Study Groups

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nasal foralumab 10 μg daily

Group A: nasal foralumab 10 μg daily for 5 days

Group Type EXPERIMENTAL

Foralumab Nasal

Intervention Type DRUG

foralumab nasal spray

nasal foralumab 50 μg daily

Group B: nasal foralumab 50 μg daily for 5 days

Group Type EXPERIMENTAL

Foralumab Nasal

Intervention Type DRUG

foralumab nasal spray

nasal foralumab 250 μg daily

Group C: nasal foralumab 250 μg daily for 5 days

Group Type EXPERIMENTAL

Foralumab Nasal

Intervention Type DRUG

foralumab nasal spray

placebo

The placebo was acetate buffer. It was handled in a manner identical to active drug.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo nasal spray

Interventions

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Placebo

Placebo nasal spray

Intervention Type DRUG

Foralumab Nasal

foralumab nasal spray

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men or women ages 18 to 65 years
* Healthy adults
* Ability and willingness to provide informed consent and comply with study requirements and procedures

Exclusion Criteria

* Chronic medical disease compromising organ function
* Corticosteroids within the past month
* Pregnancy or lactating
* Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, asthma, thyroid disease, or type I diabetes
* Chronic rhinitis, deviated septum, nasal polyps, history of sinusitis treated within the past year.
* Participation in another clinical trial within the past 30 days
* Known history of drug or ETOH abuse
* Screening labs outside of the normal range; EBV IgM positive subjects with clinical signs will not receive study drug
* Nasal corticosteroids; antihistamines; nasal flu dosing within 30 days

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes