Status:
COMPLETED
Safety, Tolerability and Immune Effects of the Nasal Foralumab in Healthy Human Volunteers
Lead Sponsor:
Tiziana Life Sciences LTD
Conditions:
Safety
Tolerability
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 dos...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2020
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06879067
Start Date
November 12 2018
End Date
November 9 2020
Last Update
March 17 2025
Active Locations (1)
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1
Ann Romney Center for Neurologic Diseases
Boston, Massachusetts, United States, 02115