A Double-Blind, Placebo-Controlled, Single Ascending Intravenous Infusion Study of rHIgM22 in Patients with Multiple Sclerosis

Study ID
STU 112013-029

Cancer Related
No

Healthy Volunteers
Yes

Study Sites

Contact
Holly Lawrence
214/404-4239
holly.lawrence@utsouthwestern.edu

Principal Investigator
Benjamin Greenberg

Summary

This is a Phase i, multi-center, double-blind, randomized, placebo-controlled, dose-escalation
study designed to evaluate safety, tolerability, pharmacokinetics, immunogenicity, and
preliminary pharmacodynamics of single intravenous (iV) administrations of rHigM22 in
patients with all clinical presentations of Multiple sclerosis (MS).

This site will be begin with the study in level 5 - Level 5 will be considered as the maximally tolerated dose (MTD). if any Dose limiting toxicity (DLT)s are observed then the MTD will be considered to be the highest dose level at which no DLTs were observed. upon establishment of an MTD, a new group of patients will be enrolled in an expansion Cohort that is comprised of 21 patients randomly assigned in a 1:1:1 ratio to 1 of 3 treatment groups: placebo, the
investigational product at the MTD, or the investigational product at one full dose level lower than
the MTD. The patients in the expansion Cohort will undergo procedures and examinations that are
additional to those planned for the patients in the earlier cohorts.

Participant Eligibility

Patients may be included in the study if they meet all the following criteria:
1. Able to give written informed consent, with adequate cognitive function to sign the IRB approved
informed consent
2. Meet diagnostic criteria for MS, as defined by revised (2010) McDonald criteria18 (See
Appendix 17.1)
3. Man or woman aged 18 to 70 years, inclusive (i.e., on or after their 18th birthday, up to
the day before their 71st birthday at the Screening Visit)
4. Women of childbearing potential must have a negative serum pregnancy test at the
Screening Visit and practice adequate contraception (as described below in Exclusion
criterion #2) for the duration of the study
5. Women of childbearing potential and engaged in heterosexual relations must agree to
practice adequate contraception (as described below in Exclusion criterion #2) for at least
60 days after study dosing. Women of childbearing potential and not engaged in
heterosexual relations or not practicing adequate contraception must agree to remain
abstinent for at least 60 days after study dosing
6. Men must be sterile based on verbal report of vasectomy, or must agree to use two
methods of contraception for at least 60 days after study dosing. One method of
contraception is a barrier method and the second method is to be utilized by the female
partner and must be one of the following: tubal ligation; implantable contraception
device; oral, patch or injectable contraceptive.
7. Agree to remain in the hospital for the 48 hour post infusion observation period, and can
be contacted in case of an emergency once discharged
8. Body weight not greater than 200 kg
9. Agree to answer the questions on the Columbia Suicide Severity Rating Scale (see
Appendix 17.3) at each specified visit