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

A Phase I Study of the Safety, Tolerability and Immune Effects of the Nasal Anti-CD3 Monoclonal Antibody Foralumab in Healthy Human Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Tolerability; Safety
• Intervention / Treatment: Drug: Placebo; Drug: Foralumab Nasal

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Ann Romney Center for Neurologic Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nasal foralumab 10 μg daily; Group A: nasal foralumab 10 μg daily for 5 days	Drug: Foralumab Nasal; foralumab nasal spray
Experimental: nasal foralumab 50 μg daily; Group B: nasal foralumab 50 μg daily for 5 days	Drug: Foralumab Nasal; foralumab nasal spray
Experimental: nasal foralumab 250 μg daily; Group C: nasal foralumab 250 μg daily for 5 days	Drug: Foralumab Nasal; foralumab nasal spray
Placebo Comparator: placebo; The placebo was acetate buffer. It was handled in a manner identical to active drug.	Drug: Placebo; Placebo nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1 vs End of Study (Day 30)
Immune Effect	Determine the dose at which immune effects are observed in subjects treated with Foralumab	Dat 1 vs End of Study (Day 30)

Collaborators and Investigators

• Sponsor: Tiziana Life Sciences LTD

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2018
• Primary Completion (Actual): July 23, 2019
• Study Completion (Actual): November 9, 2020

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: tolerability; safety; phase 1; foralumab
• Other Study ID Numbers: 134155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No