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A Phase I Study of TRN501 in Healthy Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Phase I Study of TRN501 in Healthy Volunteers

A Phase I Study to Evaluate the Safety and Pharmacokinetics of TRN501 in Healthy Adult Japanese Male Volunteers

NCT06453551•SNLD, Ltd.

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of TRN501 following a single administration of TRN501 or placebo to healthy adult male volunteers.

Eligibility

Age

18 - 45 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•The person who has been fully informed of the purpose and details of this clinical study prior to the start of screening and who has given his written consent to participate in this clinical study of his own free will.
•Japanese healthy adult male volunteers between the ages of 18 and 45 on the date of obtaining written consent.
•Those whose weight at the time of screening is 50 kg or more and Body Mass Index (BMI) between 18.5 kg/m\^2 and 25.0 kg/m\^2.
•Those who have been diagnosed as healthy by the investigator in charge of the screening test and are deemed to be eligible for this study.
•For participants who have a fertile partner or a pregnant female partner, those who agree to dual contraception by combining vasectomy or condom use for the male participant and another contraceptive method for the female partner (tubal ligation, intrauterine contraceptive device, or oral contraceptive) from the date of signing the informed consent form until the end of the study.

Exclusion Criteria

•Persons with disease or findings that are judged to affect this clinical study from the viewpoint of safety and/or evaluation.
•Persons with mental, central nervous system, cardiopulmonary, hepatic, renal, hematological, metabolic, or other diseases that may affect this study.
•A lifetime history of suicide attempts (including ongoing, previously interrupted or aborted attempts) or suicidal ideation within 6 months prior to screening. Assess using the C-SSRS. If there is a history of suicidal ideation, the timing of the ideation should be confirmed.
•* Those with abnormal resting blood pressure and pulse rate (any of the following) at screening.
•* Supine systolic blood pressure 140 mmHg or above or less than 90 mmHg
•* Supine diastolic blood pressure 90 mmHg or above or less than 50 mmHg
•* Supine pulse rate of less than 40 beats per minute or more than 100 beats per minute
•* Systolic blood pressure in the standing position (after 3 minutes in the standing position) is 20 mmHg or more lower than in the supine position, or symptoms such as dizziness are present.
•Those with hemoglobin level less than 13.0 g/dL at screening.
•Others who have abnormal findings in blood or urine tests and who are judged by the investigator to be unsuitable as participants for this study.
+11 more criteria

Locations (1)

Clinical Research Hospital Tokyo

Shinjuku-ku, Tokyo, Japan

Key Dates

Start Date

May 10, 2024

Primary Completion Date

September 20, 2024

Completion Date

September 20, 2024

Last Updated

February 7, 2025

Enrollment

ACTUAL participants

Conditions

Parkinson Disease

Interventions

TRN501 - Dose 1

DRUG

TRN501 - Dose 2

DRUG

TRN501 - Dose 3

DRUG

TRN501 - Dose 4

DRUG

TRN501 - Dose 5

DRUG

TRN501 - Dose 6

DRUG

TRN501 - Dose 7

DRUG

TRN501 - Dose 8

DRUG

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920

Parkinson Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase I Study of TRN501 in Healthy Volunteers

Inclusion Criteria

Exclusion Criteria

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations