*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, after single and multiple dosing*

Completed

• Conditions: Multiple sclerosis; nervous system disease; 10007951

• Registration Number: NL-OMON34913
• Lead Sponsor: Delta Crystallon BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 76

Inclusion Criteria

• you have given your written consent to take part in this study;
• you are between 18 and 55 years of age (inclusive);
• you are in good physical and mental health;
• your body weight must be appropriate in relation to your height;
•The use of suitable anti conception in the 3 months before start of the study and you will remain using this until 3 months after the study and/or you can not invoke an pregnancy (males) or you can not get pregnant (females)
• no abnormalities are diagnosed during the screening.

Exclusion Criteria

•If you are pregnant, planning to get pregnant or breastfeeding;
•If you have relatives (1st degree) who have MS;
•If you smoke 5 or more cigarettes per day or are not able to stop smoking during the admission period;
•If you have abused drug (past and present) and or alcohol
•The use of prescribed medication in the 14 days before start of the study, except for hormone based anticonceptionals, standard vitamines and paracetamol;
•If you recieved a vaccination within the 4 weeks before the start of the study;
•you have taken part in another clinical drug study during the last 3 months prior to the study;
• you have donated blood in the three months before admission;
•you have donated plasma in the 7 days before admission;
•if you have recieved bloodproducts in the 6 month before start of start of the study;
• you are Hepatitis B, C or HIV positive;
If no immune response can be achieved by DC-TAB in your blood;
•you are not suitable to participate in this study according to the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the safety and tolerability of DC-TAB following a single dose and<br /><br>following repeated dosing in healthy volunteers.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the pharmacokinetics of DC-TAB following a single dose and following<br /><br>repeated dosing in healthy volunteers.<br /><br>To evaluate the T-cell tolerizing effect of DC-TAB in healthy volunteers. To<br /><br>evaluate levels of DC-TAB specific and -neutralizing antibodies.</p><br>