A Phase I Study of the Safety, Tolerability and Immune Effects of the Nasal Anti-CD3 Monoclonal Antibody Foralumab in Healthy Human Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Tiziana Life Sciences LTD
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Safety- Adverse Events
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Other
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
The treating physician and subjects will be blinded to treatment. The BWH IDS pharmacy will have the treatment code assignments.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
nasal foralumab 10 μg daily
Group A: nasal foralumab 10 μg daily for 5 days
Intervention: Foralumab Nasal (Drug)
nasal foralumab 50 μg daily
Group B: nasal foralumab 50 μg daily for 5 days
Intervention: Foralumab Nasal (Drug)
nasal foralumab 250 μg daily
Group C: nasal foralumab 250 μg daily for 5 days
Intervention: Foralumab Nasal (Drug)
placebo
The placebo was acetate buffer. It was handled in a manner identical to active drug.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Safety- Adverse Events
Time Frame: 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
Time Frame: Dat 1 vs End of Study (Day 30)
Determine the dose at which immune effects are observed in subjects treated with Foralumab
Secondary Outcomes
No secondary outcomes reported