Phase 1b Multiple Ascending Dose Study of Foralumab in Primary and Secondary Progressive MS

Sponsor
Tiziana Life Sciences LTD
Study ID
NCT05029609
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Intranasal Foralumab Solution — DRUG
    The Aptar Unidose device will be used to deliver foralumab nasal solution intranasally. Foralumab nasal solution is prepackaged in a Type 1 glass vial inside the Unidose device.
  • Placebo — DRUG
    The placebo nasal solution is the acetate buffer vehicle used for foralumab nasal solution. It will be handled in a manner identical to active drug.

Study Details

The primary objective is to establish the safety of administration of intranasal Foralumab in non-active primary and secondary progressive Multiple Sclerosis (MS) patients in a multiple ascending dose format in escalating doses for 14 consecutive days.

Key Dates

Start date
Oct 31, 2021
Status verified
Feb 2022
Primary completion
Nov 30, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Other: Group A
    Group A will receive nasal Foralumab Dose 1 daily for 14 days (n=9) or placebo (n=3)
  • Other: Group B
    Group B will receive nasal Foralumab Dose 2 tiw for 14 days (n=9) or placebo (n=3)
  • Other: Group C
    Group C will receive nasal Foralumab Dose 3 daily for 14 days (n=9) or placebo (n=3)
  • Other: Group D
    Group D will receive nasal Foralumab Dose 4 daily for 14 days (n=9) or placebo (n=3)

Primary Outcome Measure

To establish the safety of intranasal foralumab in non-active primary and secondary progressive MS in escalating doses for 14 consecutive days [ Time Frame: 14 days ]

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