Healthy Volunteers
Conditions
Keywords
dosimetry, biodistribution, safety, 99mTc-duramycin
Brief summary
Conduct a first-in-human study in healthy volunteers to show safety, biodistribution and dosimetry of \[99mTc\]Duramycin.
Detailed description
Monocenter, prospective microdosing study in healthy volunteers. Healthy volunteers will undergo a \[99mTc\]Duramycin whole-body planar and abdominal SPECT scan at different time points after one iv injection of the radiotracer (1 h, 2h, 3h, 6h and 24h), while vital signs, urine and faces analysis will be checked. Blood samples will be taken at 12 different time points: 9 blood samples for dosimetry study and 3 blood samples will be subjected to clinical laboratory chemistry (renal and liver function chemistry, hematology, and blood coagulation parameters).
Interventions
DRUG99mTc-Duramycin
This is a single dose study of 99mTc-duramycin in healthy volunteers who will undergo serial SPECT scanning
Sponsors
Molecular Targeting Technologies, Inc.
University Hospital, Antwerp
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Males (n=4) or females (n=4) age 18 years or older * Stated willingness to comply with all study procedures and availability for the duration of the study. * Ability to give study-specific written informed consent.
Exclusion criteria
* Pregnant or lactating females (positive pregnancy test) * Metal implants (e.g. pacemakers, osteosynthesis material) * Body weight \> 100 kg * Severe claustrophobia * Abnormal kidney or liver function tests * Unable to comply with study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the biodistribution of [99mTc]Duramycin. | 24 hours | Subjects will be dosed with 99mTc-Duramycin at Time 0 on Day 0, and a SPECT scan will be conducted immediately after the injection. Imaging will be repeated at 1 hour, 2 hours, 3 hours, 6 hours and 24 hours after dosing. All images generated will be reviewed for biodistribution. |
| Determine the dosimetry evaluation of [99mTc]Duramycin. | 24 hours | Subjects will be dosed with 99mTc-Duramycin at Time 0 on Day 0, and a SPECT scan will be conducted immediately after the injection. Imaging will be repeated at 1 hour, 2 hours, 3 hours, 6 hours and 24 hours after dosing. All images generated will be reviewed for dosimetry. |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 72 hours |
Countries
Belgium
Outcome results
None listed