To Evaluate Dose and Safety of NanoEcho Particle-1 Using NanoEcho Imaging Device Examinations of Rectal Lymph Nodes in Healthy Volunteers and Rectal Cancer Patients.

Exclusion Criteria

• •Part A
• •1. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant's ability to participate in the trial.
• •2. Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of IMP.
• •3. Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.
• •4. Any planned major surgery within the duration of the trial.
• •5. Any previous or current anorectal disorder which may increase risk or burden of trial participation.
• •6. Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis C antibodies and/or human immunodeficiency virus (HIV).
• •7. After 10 minutes supine rest at the screening visit, any vital signs values outside the following ranges: - Systolic blood pressure: \<90 or ≥140 mmHg, or - Diastolic blood pressure \<50 or ≥90 mmHg, or - Pulse \<40 or ≥90 bpm
• •8. Prolonged QTcF (\>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the screening visit, as judged by the Investigator.
• •9. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to the IMP, IMP excipients or other parenteral iron products, or excipients of the enema to be used in the trial.
• •10. Person with pacemaker.
• •11. Person with metal implants.
• •12. Previous history of full radiation of rectum.
• •13. Regular use of any prescribed or non-prescribed medications, including antacids, analgesics, herbal remedies, vitamins and minerals, within 2 weeks prior to the (first) administration of IMP, except occasional intake of paracetamol (maximum 2000 mg/day and not exceeding 3000 mg/week), as well as nasal decongestants without cortisone, antihistamine or anticholinergics for a maximum of 10 days, at the discretion of the Investigator.
• •14. Planned treatment or treatment with another investigational drug within 3 months prior to Day -1. Participants consented and screened but not dosed in previous phase I trials are not to be excluded.
• •15. Current smokers or users of nicotine products. Irregular use of nicotine (e.g., smoking, snuffing, chewing tobacco) less than three times/week is allowed before the screening visit.
• •16. Positive screening result for drugs of abuse or alcohol at the screening visit or on admission to the trial site prior to the (first) administration of the IMP. (Positive results that are expected given the participant's medical history and prescribed medications can be disregarded as judged by the Investigator.)
• •17. History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
• •18. Presence or history of drug abuse, as judged by the Investigator.
• •19. History of, or current use of anabolic steroids, as judged by the Investigator.
• •20. The Investigator considers the participant unlikely to comply with trial procedures, restrictions and requirements.
• •Part B History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant's ability to participate in the trial.
• •2\. Person with any kind of stoma. 3. Person with pacemaker. 4. Person with metal implants. 5. Previous history of radiation of rectum. 6. Prescence of malignancy other than rectal cancer. 7. After 10 minutes supine rest at the screening visit, any vital signs values outside the following ranges: - Systolic blood pressure: \<90 or ≥140 mmHg, or - Diastolic blood pressure \<50 or ≥90 mmHg, or - Pulse \<40 or ≥90 bpm 8. Prolonged QTcF (\>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the screening visit, as judged by the Investigator.
• •9\. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to the IMP, IMP excipients or other parenteral iron products.
• •10\. Planned treatment or treatment with another investigational drug within 3 months prior to Day -1. Participants consented and screened but not dosed in previous phase I trials are not to be excluded.
• •11\. The Investigator considers the participant unlikely to comply with trial procedures, restrictions and requirements.