To quantify and assess intra- and inter-subject variability in mast cell density among healthy male and female volunteers. Serum tryptase values will also be quantified.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
methodology study
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The following are defined as the study parameters:
* Skin mast cell density
* Serum tryptase
* Adverse Events (AEs)
Secondary outcome
Not applicable
Background summary
Mast cell numbers vary significantly between different anatomical sites when
analyzed in biopsies obtained from different subjects. This study is designed
to quantify the variability of mast cell numbers within a subject from biopsies
obtained in the same anatomical region on the same day and approximately 14
days apart. Comparing samples from the same arm at the same time, from the same
arm at different times, and from different arms will help inform the utility of
measuring mast cell numbers in future interventional studies with an
investigational product that has the potential to deplete mast cells.
Study objective
To quantify and assess intra- and inter-subject variability in mast cell
density among healthy male and female volunteers. Serum tryptase values will
also be quantified.
Study design
This is a single site, non-interventional, methodology study in healthy
subjects.
After assessing eligibility during a 28-day screening period, 12 subjects will
participate in the study. On Day 1 and Day 15 (± 2 days), subjects will come to
the study center. On each of these days, a blood sample for serum tryptase will
be drawn and subsequently two skin biopsies, each collecting 3 mm of skin, will
be performed. Subjects will be released from the unit on the same day, once all
procedures have been performed. On Day 22 (± 2 days), a follow-up safety phone
call will take place.
Study burden and risks
The risk is small, the subjects will be closely monitored. The subjects will be
regularly questioned for any side-effects and regular safety tests are
scheduled (ECG/vital signs/physical exam/safety lab testing). The subject will
be asked to report, as soon as possible, any changes in physical and/or mental
well being.
The site where skin is collected, may be tender and/or painful for 1 or 2 days
after the biopsy. If the wound starts to bleed excessively, and/or becomes red
and warm, you have to contact the research physician.
Technology Square 400, 10th Floor
Cambridge MA 02139
US
Technology Square 400, 10th Floor
Cambridge MA 02139
US
Listed location countries
Age
Inclusion criteria
1. Healthy male and female subjects (healthy defined as no clinically relevant
abnormalities identified by a detailed medical history, physical examination,
including vital sign assessments) aged between 18 and 55 years of age
(inclusive) at the time of screening.
2. Understands the study and gives written informed consent for study
participation.
3. Body Mass Index (BMI) *17.5 kg/m2 and * 30.0 kg/m2.
Exclusion criteria
1. Subject reports a recent or current medical condition that might
significantly affect the outcome of the study as decided by the Principal
Investigator.
2. Pre-existing urticaria or atopic dermatitis.
3. History of melanoma.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL75384.056.20 |