Phase Ib, Administration the IOP Injection for MRI Contrast Agent in Healthy Subjects

NCT03399214 | Completed Phase 1

• 1 other identifier: IOP-CT-002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to assess the dose dependent changes in MRI signal intensity (SI) in liver after IOP Injection intravenous administration in healthy volunteers.

Conditions

Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• The Change of MRI SI (%) in vessels, liver, and spleen

  The optimal imaging time of IOP injection for the maximum SI (%)

  Day1: within 60 mins after IOP administration

Secondary Outcomes (2)

• The changes from baseline in hematology data

  within 14 days

• The incidence of all treatment-related adverse events (TRAE)

  within 14 days

Study Arms (2)

IOP Injection, Phase 1b, Cohort 1

EXPERIMENTAL

IV injection, 0.27 mg/kg

Drug: IOP Injection

IOP Injection, Phase 1b, Cohort 2

EXPERIMENTAL

IV injection, 0.54 mg/kg

Drug: IOP Injection

Interventions

IOP Injection DRUG

T1 and T2

IOP Injection, Phase 1b, Cohort 1; IOP Injection, Phase 1b, Cohort 2

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male, age ≥ 20 \~40 years, BMI=18\~27.
• The biochemistry test results, complete blood count (CBC) test results, urinalysis test results, coagulation time test results must within normal range or considered clinically normal by the clinical investigator at screening.
• Male subjects must take reliable contraceptive method(s) during and after the study for a period of 14 days.
• No screening of drug or alcohol abuse within one year prior to study enrollment.
• Subjects are willing to comply with the protocol and sign informed consent form.

You may not qualify if:

• Subjects have serious allergic history or known allergy to MRI contrast agent.
• Subjects with HBV, HCV, HIV.
• Imaging and/or functional abnormalities of liver and/or spleen.
• Subjects have alcohol or caffeine consumption within 48 hours prior to the administration of study contrast agent.
• Subjects have electronically, magnetically and mechanically activated implanted devices.
• Subjects have participated in other investigational trials or receive any contrast agents within 28 days prior to study enrollment.
• Subjects with active systemic infections, active and clinically significant cardiac diseases, active gastrointestinal ulcers, or medical conditions that may significantly affect action, adequate absorption and elimination of investigational contrast agent.
• Subjects have taken any food 6 hours prior to administration.

Sponsors & Collaborators

• MegaPro Biomedical Co. Ltd.: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei County, 112, Taiwan

Location

Study Officials

• Rheun-Chuan Lee, MD

  rclee@vghtpe.gov.tw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 16, 2018
• Study Start: April 1, 2018
• Primary Completion: May 1, 2018
• Study Completion: July 31, 2018
• Last Updated: August 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)