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

Phase 1

Completed

• Conditions: Safety; Tolerability
• Interventions: Drug: Foralumab Nasal; Drug: Placebo

• Registration Number: NCT06879067
• Lead Sponsor: Tiziana Life Sciences LTD

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2018-11-12
• Primary Completion: 2019-07-23
• Study Completion: 2020-11-09
• Status Verified: 2025-03
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
nasal foralumab 10 μg daily	Foralumab Nasal	Group A: nasal foralumab 10 μg daily for 5 days
nasal foralumab 50 μg daily	Foralumab Nasal	Group B: nasal foralumab 50 μg daily for 5 days
nasal foralumab 250 μg daily	Foralumab Nasal	Group C: nasal foralumab 250 μg daily for 5 days
placebo	Placebo	The placebo was acetate buffer. It was handled in a manner identical to active drug.

Primary Outcome Measures

Name	Time	Method
Safety- Adverse Events	Day 1 vs End of Study (Day 30)	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.
Immune Effect	Dat 1 vs End of Study (Day 30)	Determine the dose at which immune effects are observed in subjects treated with Foralumab

Trial Locations

Locations (1)

Ann Romney Center for Neurologic Diseases; 🇺🇸 Boston, Massachusetts, United States