Safety, Tolerability and Immune Effects of the Nasal Foralumab in Healthy Human Volunteers

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Tiziana Life Sciences LTD
Study ID
NCT06879067
Phase
PHASE1
Status
Completed

Conditions

  • Safety
  • Tolerability

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Placebo — DRUG
    Placebo nasal spray
  • Foralumab Nasal — DRUG
    foralumab nasal spray

Study Details

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.

Key Dates

Start date
Nov 12, 2018
Status verified
Mar 2025
Primary completion
Jul 23, 2019
Completion
Nov 9, 2020

Study Design

Enrollment
27 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: nasal foralumab 10 μg daily
    Group A: nasal foralumab 10 μg daily for 5 days
  • Experimental: nasal foralumab 50 μg daily
    Group B: nasal foralumab 50 μg daily for 5 days
  • Experimental: nasal foralumab 250 μg daily
    Group C: nasal foralumab 250 μg daily for 5 days
  • Placebo Comparator: placebo
    The placebo was acetate buffer. It was handled in a manner identical to active drug.

Primary Outcome Measure

Safety- Adverse Events [ Time Frame: Day 1 vs End of Study (Day 30) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ann Romney Center for Neurologic DiseasesBostonMassachusetts02115-

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By research site
Ann Romney Center for Neurologic Diseases· Boston, MA

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