Safety Study of GNbAC1 Monoclonal Antibody in Healthy Male Volunteers
A Randomised, Double-Blind, Placebo Controlled, Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
2 other identifiers
interventional
21
1 country
1
Brief Summary
In this clinical study, the safety and tolerability of GNbAC1 as a treatment for MS patients will be evaluated in healthy male volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Apr 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 21, 2015
CompletedFirst Posted
Study publicly available on registry
May 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedOctober 20, 2020
August 1, 2015
4 months
May 21, 2015
October 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
safety and tolerability of single ascending doses of GNbAC1 in healthy male subjects
AE, SAE, vital signs, ECG, clinical laboratory values
57 days
Secondary Outcomes (3)
PK characteristics: GNbAC1 serum concentrations
57 days
immunogenicity in terms of antibodies against GNbAC1 (anti-drug antibodies)
57 days
ratio of serum to CSF GNbAC1 concentration
29 days
Study Arms (3)
6 mg/kg GNbAC1
ACTIVE COMPARATOR7 subjects randomized 5:2 active treatment:placebo
18 mg/kg GNbAC1
ACTIVE COMPARATOR7 subjects randomized 5:2 active treatment:placebo
36 mg/kg GNbAC1
ACTIVE COMPARATOR7 subjects randomized 5:2 active treatment:placebo
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male subjects as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at Screening and confirmed at Day -1 who have signed the informed consent.
- Aged from 18 to 55 years, both inclusive.
You may not qualify if:
- History of serious adverse reactions or hypersensitivity to any drug.
- Presence or history of any allergy requiring acute or chronic treatment (seasonal allergic rhinitis that requires no treatment may be tolerated).
- Need of any prescription medication within 15 days prior to the administration of the study drug and/or non-prescription medication within 7 days prior to the administration of the study drug or anticipated need for any concomitant medication during the study.
- Participation in a clinical trial during the previous 3 months, i.e. from completion of the previous trial to the planned first administration of the current trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PAREXEL Early Phase Clinical Unit
Berlin, 14050, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Georg Golor, MD
Parexel
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2015
First Posted
May 25, 2015
Study Start
April 1, 2015
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
October 20, 2020
Record last verified: 2015-08