Study of tolerability, biodistribution and dosimetry of Technetium-99m radiolabelled Fucoida

Completed

Conditions: healthy volunteers in this study
in the future cardiovasular disease
10014523

Registration Number: NL-OMON46586

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Adult subjects of either gender, aged 18 years or older
- BMI between 18 and 35 kg/m2
- Effective contraception in women of childbearing age
- Use of effective contraception in men for 24 hours after injection of 99mTc-Fucoidan

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Progressive and chronic disease
- Chronic infection with HIV, HBV or HCV
- Clinically significant abnormalities during screening
- Pregnancy or breast-feeding
- Active medication use or previous long-term intake of medication
- Any other treatment that could interfere with the conduct or interpretation of the study in the opinion of the investigator
- Any other clinically relevant condition that could interfere with the conduct of the study in the opinion of the investigator
- Standard contra-indications to SPECT/CT
- Inability or unwilling to comply with protocol requirements, or deemed by the investigator to have a disorder that may compromise the ability to give informed

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is tolerability based on the following: adverse events,<br /><br>vital signs, clinical examination, ECG, clinical laboratory measurements.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives are to determine:<br /><br>1. Biodistribution (blood clearance, tissue distribution)<br /><br>2. Dosimetry (effective dose [in mSv] per organ and per individual determined<br /><br>from biodistribution). </p><br>