NCT03630497

BN201 SAD MAD Study in Healthy Subjects

Completed Phase 1 Last updated 10 April 2019

What this trial tests

Phase 1 trial testing Comparison of BN201 treatment with Placebo in Optic Neuritis in 48 participants. Completed in 22 February 2019.

Timeline

27 May 2018

Primary endpoint
1 February 2019

22 February 2019

Quick facts

Lead sponsor	Accure Therapeutics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	48
Start date	27 May 2018
Primary completion	1 February 2019
Estimated completion	22 February 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

• Comparison of BN201 treatment with Placebo — full drug profile →

Conditions studied

• Optic Neuritis — all drugs for Optic Neuritis →
• Optic; Neuritis, With Demyelination — all drugs for Optic; Neuritis, With Demyelination →

Sponsor

Accure Therapeutics — full company profile →

Who can join

Adults 18 to 55, any sex, with Optic Neuritis or Optic; Neuritis, With Demyelination. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of BN201 in healthy subjects.

This is a phase I, randomised, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of BN201 in healthy subjects following single ascending doses and two cohorts of multiple doses. The study will be conducted in two parts (Part A and Part B). Part A (up to 8 single ascending doses (SD)) will be conducted in 32 subjects (4 interlocking cohorts of 8 subjects). Part B (up to 2 multiple ascending doses (MD)) will be conducted in 16 subjects (2 cohorts of 8 subjects). Subjects in Part A will undergo a screening period (Day -28 to Day -2), two in-patient treatment periods compromising 3 overnight stays (from Day -1 to Day 3) with a wash out period of at least 14 days between dose administrations and a follow up visit 12 to 16 days following administration of IMP. Subjects in Part B will undergo a screening period (Day -28 to Day -2), an in-patient treatment period compromising 7 overnight stays (from Day -1 to Day 7) and a follow up visit 12 to 16 days following final administration of Investigational Medicinal Product (IMP).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Breaking the barriers to remyelination in multiple sclerosis.
   Gharagozloo M, Bannon R, Calabresi PA. · · 2022 · cited 19× · PMID 35255453 · DOI 10.1016/j.coph.2022.102194
2. Remyelination in animal models of multiple sclerosis: finding the elusive grail of regeneration.
   Packer D, Fresenko EE, Harrington EP. · · 2023 · cited 10× · PMID 37448959 · DOI 10.3389/fnmol.2023.1207007
3. Axonal and Myelin Neuroprotection by the Peptoid BN201 in Brain Inflammation.
   Villoslada P, Vila G, Colafrancesco V, Moreno B, et al · · 2019 · cited 10× · PMID 30815844 · DOI 10.1007/s13311-019-00717-4