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A First-in-human Clinical Evaluation of SN132D in Patients With Breast and Pancreatic Cancer

NCT04080024 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2022-12-09

No results posted yet for this study

Summary

This phase I, first-in-human (FIH) study is open-label, non-randomised and non-placebo-controlled. The study is designed to evaluate the safety, tolerability and pharmacokinetics (PK) of a single intravenous dose of SN132D in approximately 24 patients with breast and pancreatic cancer. Magnetic resonance imaging (MRI) will be performed pre- and post-infusion of SN132D.

Conditions

Interventions

DRUG

SN132D

Novel manganese-based macromolecular MRI contrast agent

Sponsors & Collaborators

  • CTC Clinical Trial Consultants AB

    collaborator INDUSTRY

  • Antaros Medical

    collaborator INDUSTRY

  • Spago Nanomedical AB

    lead INDUSTRY

Principal Investigators

  • Folke Sjöberg, MD, Prof · CTC Clinical Trial Consultants AB

  • Dan Curiac, MD, PhD · Gothia Forum Clinical Trial Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-23
Primary Completion
2022-11-30
Completion
2022-11-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04080024 on ClinicalTrials.gov