Clinical trial NCT06879067: Safety, Tolerability and Immune Effects of the Nasal Foralumab in Healthy Human Volunteers
Official title: A Phase I Study of the Safety, Tolerability and Immune Effects of the Nasal Anti-CD3 Monoclonal Antibody Foralumab in Healthy Human Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety
Tolerability
Keywords: foralumab
safety
tolerability
phase 1
Lead sponsor: Tiziana Life Sciences LTD
Sponsor class: INDUSTRY
First posted: 2025-03-17
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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 purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety- Adverse Events
timeFrame: Day 1 vs End of Study (Day 30)
measure: Immune Effect
timeFrame: Dat 1 vs End of Study (Day 30)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Ann Romney Center for Neurologic Diseases
state: Massachusetts
Study officials:
References: