A Study of Oral Foralumab in Participants With Moderate to Severely Active Crohn's Disease

Sponsor
Tiziana Life Sciences LTD
Study ID
NCT05028946
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Foralumab — DRUG
    Foralumab will be administered per dose and schedule specified in the arm description.

Study Details

The primary objective of this study is to establish the safety and tolerability of multiple ascending doses (MAD) of foralumab enteric coated capsules administered orally, once daily for 5 days per week over 2 weeks in participants with moderate to severely active Crohn's Disease (CD).

Key Dates

Start date
May 1, 2022
Status verified
Oct 2022
Primary completion
Jul 7, 2023
Completion
Nov 7, 2023

Study Design

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

Arms

  • Experimental: Cohort 1: Foralumab Dose Level 1
    Participants will receive foralumab enteric coated capsules at dose level 1, administered orally once daily for 2 weeks (5 consecutive days in each week with a 2-day undosed safety assessment period after each 5 day treatment period).
  • Experimental: Cohort 2: Foralumab Dose Level 2
    Participants will receive foralumab enteric coated capsules at dose level 2, administered orally once daily for 2 weeks (5 consecutive days in each week with a 2-day undosed safety assessment period after each 5 day treatment period).
  • Experimental: Cohort 3: Foralumab Dose Level 3
    Participants will receive foralumab enteric coated capsules at dose level 3, administered orally once daily for 2 weeks (5 consecutive days in each week with a 2-day undosed safety assessment period after each 5 day treatment period).
  • Experimental: Cohort 4: Foralumab Dose Level 4
    Participants will receive foralumab enteric coated capsules at dose level 4, administered orally once daily for 2 weeks (5 consecutive days in each week with a 2-day undosed safety assessment period after each 5 day treatment period).

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 up to Day 14 ]

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