Safety, Tolerability and Immune Effects of the Nasal Foralumab in Healthy Human Volunteers
Launched by TIZIANA LIFE SCIENCES LTD · Mar 11, 2025
Trial Information
Current as of April 22, 2025
Completed
Keywords
ClinConnect Summary
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 ...
Gender
ALL
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
About Tiziana Life Sciences Ltd
Tiziana Life Sciences Ltd. is a biotechnology company focused on the development of innovative therapeutics for the treatment of serious diseases, including cancer and autoimmune disorders. With a strong commitment to advancing scientific research, Tiziana leverages its proprietary platform technologies to discover and develop novel drug candidates that aim to address unmet medical needs. The company is dedicated to conducting rigorous clinical trials to evaluate the safety and efficacy of its products, ultimately striving to improve patient outcomes and enhance the quality of life for individuals affected by challenging health conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported