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

Completed · Phase 1 · Has a placebo group

Conditions studied: Safety, Tolerability

In brief

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 facts

Study ID

NCT06879067

Run by

Tiziana Life Sciences LTD

People needed

27

Starts

2018-11-12

Expected to finish

2020-11-09

Last updated by the study team

2025-03-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men or women ages 18 to 65 years
• Healthy adults
• Ability and willingness to provide informed consent and comply with study requirements and procedures

You may not qualify if…

• 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

Where it is running

• Ann Romney Center for Neurologic Diseases — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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