A methodology study quantifying mast cell density in healthy volunteers

Completed

• Conditions: methodology study; not applicable

• Registration Number: NL-OMON49094
• Lead Sponsor: Third Harmonic Bio

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2021-03-26
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The following are defined as the study parameters:<br /><br>* Skin mast cell density<br /><br>* Serum tryptase<br /><br>* Adverse Events (AEs)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>