SafetyPhase 1NCT06879067
Safety, Tolerability and Immune Effects of the Nasal Foralumab in Healthy Human Volunteers
A Phase 1 study testing Foralumab Nasal in people with Safety and Tolerability, run by Tiziana Life Sciences LTD at 1 site in United States.
Trial 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 doses for 5 consecutive days and have a follow-up period. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety, Tolerability
- What is being tested?
- Foralumab Nasal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2018to 9 Nov 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women ages 18 to 65 years
- Healthy adults
- Ability and willingness to provide informed consent and comply with study requirements and procedures
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann Romney Center for Neurologic Diseases
Boston, Massachusetts, 02115
About this study
Official title: A Phase I Study of the Safety, Tolerability and Immune Effects of the Nasal Anti-CD3 Monoclonal Antibody Foralumab in Healthy Human Volunteers
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.
Read the 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 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.
- Conditions
- Safety, Tolerability
- Being tested
- Placebo, Foralumab Nasal
- Keywords
- foralumab, safety, tolerability, phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo nasal spray
Foralumab NasalDrug
foralumab nasal spray
| Study group | Role | What they receive |
|---|---|---|
| nasal foralumab 10 μg daily | Experimental | Group A: nasal foralumab 10 μg daily for 5 days Receives: Drug: Foralumab Nasal |
| nasal foralumab 50 μg daily | Experimental | Group B: nasal foralumab 50 μg daily for 5 days Receives: Drug: Foralumab Nasal |
| nasal foralumab 250 μg daily | Experimental | Group C: nasal foralumab 250 μg daily for 5 days Receives: Drug: Foralumab Nasal |
| placebo | Placebo comparator | The placebo was acetate buffer. It was handled in a manner identical to active drug. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 vs End of Study (Day 30)
Immune Effect
Determine the dose at which immune effects are observed in subjects treated with Foralumab
Measured: Dat 1 vs End of Study (Day 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start12 Nov 2018
- Primary completion23 Jul 2019
- Study completion9 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a randomized, double blind Phase I dose escalation study evaluating three dose levels of Foralumab via intranasal administration from single-dose vials. Each dose group will complete 7 days of assessment and be evaluated for safety before the study moves to the next dosing level. After the first 9 subjects complete their Day 8 visit, the next 9 subjects will be enrolled and receive 50 ug of nasal Foralumab or placebo once daily for 5 days; after the second group completes visit Day 8, the third dose group will be enrolled and receive 250 ug of nasal Foralumab/placebo once daily for 5 days.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tiziana Life Sciences LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879067
- Sponsor's protocol ID
- 134155
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Safety, Tolerability and Immune Effects of the Nasal Anti-CD3 Monoclonal Antibody Foralumab in Healthy Human Volunteers
- ClinicalTrials.gov ID
- NCT06879067
- Acronym / sponsor ID
- 134155
- Conditions
- Safety, Tolerability
- Keywords
- foralumab, safety, tolerability, phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Tiziana Life Sciences LTDIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 23 Jul 2019 (actual)
- Study completion
- 9 Nov 2020 (actual)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- This is a randomized, double blind Phase I dose escalation study evaluating three dose levels of Foralumab via intranasal administration from single-dose vials. Each dose group will complete 7 days of assessment and be evaluated for safety before the study moves to the next dosing level. After the first 9 subjects complete their Day 8 visit, the next 9 subjects will be enrolled and receive 50 ug of nasal Foralumab or placebo once daily for 5 days; after the second group completes visit Day 8, the third dose group will be enrolled and receive 250 ug of nasal Foralumab/placebo once daily for 5 days.
| Arm | Type | Receives |
|---|---|---|
| nasal foralumab 10 μg daily | Experimental | Drug: Foralumab NasalGroup A: nasal foralumab 10 μg daily for 5 days |
| nasal foralumab 50 μg daily | Experimental | Drug: Foralumab NasalGroup B: nasal foralumab 50 μg daily for 5 days |
| nasal foralumab 250 μg daily | Experimental | Drug: Foralumab NasalGroup C: nasal foralumab 250 μg daily for 5 days |
| placebo | Placebo comparator | Drug: PlaceboThe placebo was acetate buffer. It was handled in a manner identical to active drug. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women ages 18 to 65 years
- Healthy adults
- Ability and willingness to provide informed consent and comply with study requirements and procedures
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo nasal spray | Drug | placebo |
| Foralumab Nasalforalumab nasal spray | Drug | nasal foralumab 10 μg daily, nasal foralumab 250 μg daily, nasal foralumab 50 μg daily |
Primary outcome
Safety- Adverse Events
Time frame: Day 1 vs End of Study (Day 30)
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.
Immune Effect
Time frame: Dat 1 vs End of Study (Day 30)
Determine the dose at which immune effects are observed in subjects treated with Foralumab
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Foralumab Nasal in people with Safety and Tolerability, run by Tiziana Life Sciences LTD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety- Adverse Events (time frame: Day 1 vs End of Study (Day 30)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.