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

Tiziana Life Sciences LTD27 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Safety Tolerability

Interventions

PlaceboDRUG

Placebo nasal spray

Foralumab NasalDRUG

foralumab nasal spray

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Ann Romney Center for Neurologic Diseases

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Safety- Adverse Events

Establish the safety of administration of nasal Foralumab to healthy volunteers in escalating doses for 5 consecutive days. Two or more serious adverse events occur that are possibly, probably or definitely related to nasal Foralumab.

Time frame: Day 1 vs End of Study (Day 30)

Immune Effect

Determine the dose at which immune effects are observed in subjects treated with Foralumab

Time frame: Dat 1 vs End of Study (Day 30)

Data from ClinicalTrials.gov

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