Phase I clinical study for safety and pharmacokinetic evaluation of NMB58 in Japanese healthy adult male

Phase 1

Completed

• Conditions: Japanese healthy male subjects

• Registration Number: JPRN-jRCT2080224522
• Lead Sponsor: ihon Medi-Physics Co., Ltd.

Brief Summary

Regarding safety, good tolerability was confirmed. As a result of the radiation dosimetry, the absorbed dose after the administration of NMB58 was considered to have a low risk of having a deterministic effect, and the effective dose was also considered to be within an acceptable range compared to existing diagnostic radiopharmaceuticals. NMB58 is considered to have a suitable dynamics as a radiodiagnostic agent for myocardial perfusion imaging.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-16
• Study Completion: 2019-11-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

1.Have no history or symptoms of disease that would interfere with the evaluation the subjects, and no clinically significant deviation from normal ranges in screening tests (medical history, physical examination, ECG and clinical laboratory tests (hematology, biochemistry and urinalysis)).
2.Expected ability to perform a treadmill exercise stress testing sufficiently to achieve more than 85% of age-predicted maximum heart rate (APMHR). (For cohort 1 subjects)
3.Have a body mass index (BMI) of 18 to 28 at the time of screening.

Exclusion Criteria

1. Be contracting a disease or having trauma that may affect pharmacokinetics.
2. Have a history of prior allergic response to any drugs.
3. Be presence of any contraindications (absolute or relative) to exercise stress testing. (For cohort 1subjects)
4. Be presence of any contraindications to pharmacologic stress testing with adenosine or administration of aminophylline. (For cohort 2 subjects)

Study & Design

• Study Type: Interventional
• Study Design: Not specified