healthy volunteers in this study
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is tolerability based on the following: adverse events, vital signs, clinical examination, ECG, clinical laboratory measurements. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are to determine: 1. Biodistribution (blood clearance, tissue distribution) 2. Dosimetry (effective dose [in mSv] per organ and per individual determined from biodistribution). | — |
Countries
Netherlands
Outcome results
None listed