NCT02442557

A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and T-cell Tolerizing Effect of DC-TAB in Healthy Volunteers

Completed Phase 1 Last updated 12 May 2015

What this trial tests

Phase 1 trial testing recombinant human alpha B-crystallin in Multiple Sclerosis in 76 participants. Completed in 1 July 2011.

Timeline

1 December 2009

Primary endpoint
1 October 2010

1 July 2011

Quick facts

Lead sponsor	Delta Crystallon BV
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	76
Start date	1 December 2009
Primary completion	1 October 2010
Estimated completion	1 July 2011
Sites	1 location across Netherlands

Drugs / interventions tested

• recombinant human alpha B-crystallin — full drug profile →
• placebo comparator

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Delta Crystallon BV — full company profile →

Who can join

Adults 18 to 55, any sex, with Multiple Sclerosis. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Safety (adverse events)
  Time frame: 28 days
  Frequency of

Sponsor's own description

The purpose of this study is to determine safety and appropriate dose of DC-TAB for selective immune tolerance induction in humans.

Publications & conference data

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

1. Therapeutic Intervention in Multiple Sclerosis with Alpha B-Crystallin: A Randomized Controlled Phase IIa Trial.
   van Noort JM, Bsibsi M, Nacken PJ, Verbeek R, et al · · 2015 · cited 45× · PMID 26599332 · DOI 10.1371/journal.pone.0143366
2. HSPB5 suppresses renal inflammation and protects lupus-prone NZB/W F1 mice from severe renal damage.
   Knapp J, Braunstein M, Berg SIT, Shirriff C. · · 2022 · cited 4× · PMID 36510250 · DOI 10.1186/s13075-022-02958-9