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

NCT06879067 | Completed Phase 1 FDA Drug

• 1 other identifier: 134155
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Safety; Tolerability

Keywords

foralumab; safety; tolerability; phase 1

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (4)

nasal foralumab 10 μg daily

EXPERIMENTAL

Group A: nasal foralumab 10 μg daily for 5 days

Drug: Foralumab Nasal

nasal foralumab 50 μg daily

EXPERIMENTAL

Group B: nasal foralumab 50 μg daily for 5 days

Drug: Foralumab Nasal

nasal foralumab 250 μg daily

EXPERIMENTAL

Group C: nasal foralumab 250 μg daily for 5 days

Drug: Foralumab Nasal

placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Placebo DRUG

Placebo nasal spray

placebo

Foralumab Nasal DRUG

foralumab nasal spray

nasal foralumab 10 μg daily; nasal foralumab 250 μg daily; nasal foralumab 50 μg daily

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tiziana Life Sciences LTD: lead

Study Sites (1)

Ann Romney Center for Neurologic Diseases

Boston, Massachusetts, 02115, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The treating physician and subjects will be blinded to treatment. The BWH IDS pharmacy will have the treatment code assignments.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: November 12, 2018
• Primary Completion: July 23, 2019
• Study Completion: November 9, 2020
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)