A Phase 1 interventional study of Placebo and Foralumab Nasal in Safety and Tolerability, sponsored by Tiziana Life Sciences LTD. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-17.
Sponsored by Tiziana Life Sciences LTD · Phase 1, Interventional, and Other
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.
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.
Tiziana Life Sciences LTD is the lead sponsor of 14 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group A: nasal foralumab 10 μg daily for 5 days
Drug: Foralumab Nasal
Group B: nasal foralumab 50 μg daily for 5 days
Drug: Foralumab Nasal
Group C: nasal foralumab 250 μg daily for 5 days
Drug: Foralumab Nasal
The placebo was acetate buffer. It was handled in a manner identical to active drug.
Drug: Placebo
Placebo nasal spray
foralumab nasal spray
Safety- Adverse Events
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.
Time frame: Day 1 vs End of Study (Day 30)
Immune Effect
Determine the dose at which immune effects are observed in subjects treated with Foralumab
Time frame: Dat 1 vs End of Study (Day 30)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Tiziana Life Sciences LTD