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

NCT06879067 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-03-17

No results posted yet for this study

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.

Conditions

  • Safety
  • Tolerability

Interventions

DRUG

Placebo

Placebo nasal spray

DRUG

Foralumab Nasal

foralumab nasal spray

Sponsors & Collaborators

  • Tiziana Life Sciences LTD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-12
Primary Completion
2019-07-23
Completion
2020-11-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06879067 on ClinicalTrials.gov