Safety and Dose-finding Study of DC-TAB in Healthy Subjects
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
1 other identifier
interventional
76
1 country
1
Brief Summary
The purpose of this study is to determine safety and appropriate dose of DC-TAB for selective immune tolerance induction in humans.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 multiple-sclerosis
Started Dec 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 13, 2015
CompletedMay 13, 2015
May 1, 2015
10 months
May 1, 2015
May 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety (adverse events)
Frequency of
28 days
Secondary Outcomes (4)
Antigen-specific T-cell response
28 days
Pharmacokinetics (serum levels of DC-TAB)
24 h
Local tolerability (Injection site abnormalities)
28 days
Antibody responses
28 days
Study Arms (9)
single dose 4 mg
ACTIVE COMPARATORa single intravenous injection of 4 mg DC-TAB
single dose 12.5 mg
ACTIVE COMPARATORa single intravenous injection of 12.5 mg DC-TAB
single dose 25 mg
ACTIVE COMPARATORa single intravenous injection of 25 mg DC-TAB
single dose 37.5 mg
ACTIVE COMPARATORa single intravenous injection of 4 mg DC-TAB
single dose placebo
PLACEBO COMPARATORa single intravenous injection of placebo
multiple dose 10 mg
ACTIVE COMPARATORthree consecutive daily intravenous injections of 10 mg DC-TAB
multiple dose 25 mg
ACTIVE COMPARATORthree consecutive daily intravenous injections of 25 mg DC-TAB
multiple dose 37.5 mg
ACTIVE COMPARATORthree consecutive daily intravenous injections of 37.5 mg DC-TAB
multiple dose placebo
PLACEBO COMPARATORthree consecutive daily intravenous injections of placebo
Interventions
intravenous injection
intravenous injection
Eligibility Criteria
You may qualify if:
- Caucasian
- Signed the written informed consent form before first screening procedure
- Age ≥ 18 years and ≤ 55 years
- In general good health in the opinion of the investigator
- BMI between 20.0 and 28.0 kg/m2
- Use of adequate and stable contraception for 3 months prior to study initiation, during the course of the study and 30 days thereafter. Sexually active males must use a condom. Sexually active females must use double-barrier contraception or hormonal contraceptive (oral, transdermal, vaginal ring, implants), or must have undergone clinically documented total hysterectomy and/or oophorectomy, surgical sterilization or be postmenopausal defined by amenorrhea for at least 12 months and confirmed with a FSH higher than 40 IU/mL.
- If subjects claim abstinence as their method of contraception, they must be willing to agree to use condoms if they become sexually active from 14 days prior to the first dose of the study drug through 90 days beyond the conclusion of the study.
You may not qualify if:
- Pregnant women, women planning to become pregnant and breastfeeding women
- Subjects with a history of MS in first grade family members
- A history of or currently active clinically significant cardiac (including clinically significant ECG abnormalities in the opinion of the PI), pulmonary, gastrointestinal, hepatic, renal, pancreatic, or neurological disease
- ALT, AST and/or gamma-GT above 3 times the upper limit of normal
- Serum creatinine above 1.5 times the upper limit of normal
- Amylase above 1.5 times the upper limit of normal
- Hemoglobin \< 7.0 mmol/L for females and \< 8 mmol/L for males; leucocytes \> 20\*109/L or \< 3.5\*109/L; platelets \< 125\*109/L
- SBP \> 160 mmHg and/or DBP \> 100 mmHg
- Known or suspected hypersensitivity to any component of DC-TAB
- Known or suspected impairment of the immune system
- Acute respiratory or other active infections or illnesses
- Fever (oral temperature \> 38.0 °C on day 1)
- Blood donation or significant blood loss within 90 days of first study medication dosing.
- Plasma donation within 7 days of first study medication dosing
- Recipients of blood or blood products in the last 6 months
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kendle International
Utrecht, 3584CJ, Netherlands
Related Publications (1)
van Noort JM, Bsibsi M, Nacken PJ, Verbeek R, Venneker EH. Therapeutic Intervention in Multiple Sclerosis with Alpha B-Crystallin: A Randomized Controlled Phase IIa Trial. PLoS One. 2015 Nov 23;10(11):e0143366. doi: 10.1371/journal.pone.0143366. eCollection 2015.
PMID: 26599332DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Floris Höppener, PhD, MD
Syneos Health
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2015
First Posted
May 13, 2015
Study Start
December 1, 2009
Primary Completion
October 1, 2010
Study Completion
July 1, 2011
Last Updated
May 13, 2015
Record last verified: 2015-05