Safety, Tolerability
Conditions
Keywords
foralumab, safety, tolerability, phase 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.
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.
Interventions
DRUGPlacebo
Placebo nasal spray
DRUGForalumab Nasal
foralumab nasal spray
Sponsors
Tiziana Life Sciences LTD
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The treating physician and subjects will be blinded to treatment. The BWH IDS pharmacy will have the treatment code assignments.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed