NCT06453551

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1 parkinson-disease

Timeline
Completed

Started May 2024

Shorter than P25 for phase_1 parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2024

Completed
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

May 21, 2024

Last Update Submit

February 4, 2025

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (7)

  • Safety evaluation of TRN501: Incidents of Treatment-Emergent Adverse Events

    Name of adverse event, date and time of onset, severity, seriousness, outcome, date and time of outcome, and relationship to TRN501 of all adverse events (including serious adverse events) are evaluated.

    For each cohort, from the administration of investigational drug or placebo to 24 hours after the administration. If any adverse event(s) continue or occur after the end of the above time frame, follow-up will be conducted up to 4 weeks.

  • Safety evaluation of TRN501: Incidents of physical findings

    The examination will include general findings and evaluation of the skin, eyes, ears/nose/throat, heart, chest, and abdomen. Record anything that is not normal, including those due to the subject's illness.

    3 days and 2 nights (for each cohort)

  • Safety evaluation of TRN501: Vital sign (body temperature)

    The results of vital signs will be used by the investigator to determine whether there are any safety issues continuing to participate in this study.

    3 days and 2 nights (for each cohort)

  • Safety evaluation of TRN501: Vital sign (blood pressure)

    The results of vital signs will be used by the investigator to determine whether there are any safety issues continuing to participate in this study. Blood pressure is measured in sitting state.

    3 days and 2 nights (for each cohort)

  • Safety evaluation of TRN501: Vital sign (pulse rate)

    The results of vital signs will be used by the investigator to determine whether there are any safety issues continuing to participate in this study. Pulse rate is measured in sitting state.

    3 days and 2 nights (for each cohort)

  • Safety evaluation of TRN501: Columbia Suicide Severity Rating Scale (C-SSRS)

    To evaluate the safety and tolerability of TRN501, Columbia-Suicide Severity Rating Scale (C-SSRS) (Japanese version) is used to evaluates suicidal ideation and behavior. Scale range: Yes or No response to 11 questions, with minimum to maximum range of 0 to 5. Lower score represents better outcomes. Subscales not applicable.

    For each cohort, the day of entry (Day -1) and the day of leaving the facility (Day 2 or at the time of discontinuation).

  • Safety evaluation of TRN501: Incidents of participants with laboratory abnormality

    The results of laboratory test values (hematological, blood biochemical, and urinary tests) will be used by the investigator to determine whether there are any safety issues continuing to participate in this study.

    For each cohort, the day of entry (Day -1) and the day of leaving the facility (Day 2 or at the time of discontinuation).

Study Arms (8)

Single dose 1

EXPERIMENTAL

TRN501 - Dose 1

Drug: TRN501 - Dose 1

Single dose 2

EXPERIMENTAL

TRN501 - Dose 2

Drug: TRN501 - Dose 2

Single dose 3

EXPERIMENTAL

TRN501 - Dose 3

Drug: TRN501 - Dose 3

Single dose 4

EXPERIMENTAL

TRN501 - Dose 4

Drug: TRN501 - Dose 4

Single dose 5

EXPERIMENTAL

TRN501 - Dose 5

Drug: TRN501 - Dose 5

Single dose 6

EXPERIMENTAL

TRN501 - Dose 6

Drug: TRN501 - Dose 6

Single dose 7

EXPERIMENTAL

TRN501 - Dose 7

Drug: TRN501 - Dose 7

Single dose 8

EXPERIMENTAL

TRN501 - Dose 8

Drug: TRN501 - Dose 8

Interventions

TRN501 - Dose 1DRUG

Each cohort consists of 9 participants and includes a placebo group. 6 in the TRN501 group and 3 in the placebo group, a total of 9 participants, are randomly assigned in a double-blind fashion. To each participant, single dose of TRN501 or a placebo will be administered.

Single dose 1
TRN501 - Dose 2DRUG

Each cohort consists of 9 participants and includes a placebo group. 6 in the TRN501 group and 3 in the placebo group, a total of 9 participants, are randomly assigned in a double-blind fashion. To each participant, single dose of TRN501 or a placebo will be administered.

Single dose 2
TRN501 - Dose 3DRUG

Each cohort consists of 9 participants and includes a placebo group. 6 in the TRN501 group and 3 in the placebo group, a total of 9 participants, are randomly assigned in a double-blind fashion. To each participant, single dose of TRN501 or a placebo will be administered.

Single dose 3
TRN501 - Dose 4DRUG

Each cohort consists of 9 participants and includes a placebo group. 6 in the TRN501 group and 3 in the placebo group, a total of 9 participants, are randomly assigned in a double-blind fashion. To each participant, single dose of TRN501 or a placebo will be administered.

Single dose 4
TRN501 - Dose 5DRUG

Each cohort consists of 9 participants and includes a placebo group. 6 in the TRN501 group and 3 in the placebo group, a total of 9 participants, are randomly assigned in a double-blind fashion. To each participant, single dose of TRN501 or a placebo will be administered.

Single dose 5
TRN501 - Dose 6DRUG

Each cohort consists of 9 participants and includes a placebo group. 6 in the TRN501 group and 3 in the placebo group, a total of 9 participants, are randomly assigned in a double-blind fashion. To each participant, single dose of TRN501 or a placebo will be administered.

Single dose 6
TRN501 - Dose 7DRUG

Each cohort consists of 9 participants and includes a placebo group. 6 in the TRN501 group and 3 in the placebo group, a total of 9 participants, are randomly assigned in a double-blind fashion. To each participant, single dose of TRN501 or a placebo will be administered.

Single dose 7
TRN501 - Dose 8DRUG

Each cohort consists of 9 participants and includes a placebo group. 6 in the TRN501 group and 3 in the placebo group, a total of 9 participants, are randomly assigned in a double-blind fashion. To each participant, single dose of TRN501 or a placebo will be administered.

Single dose 8

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Those who have abnormalities in the electrocardiogram at the time of screening and who are judged by the investigator to be unsuitable as participants for this study.
  • Persons with hypersensitivity or allergy to the active ingredients or additives of TRN501 or persons with a history of severe allergies (anaphylaxis, etc.) due to other drugs.
  • Persons with chronic abnormal bowel movements (chronic constipation, chronic diarrhea, irritable bowel syndrome, etc.).
  • Persons with previous resection of the upper gastrointestinal tract (esophagus, stomach, duodenum, upper small intestine) (excluding appendicectomy).
  • Persons who have taken drugs (prescription drugs, over-the-counter drugs, herbal medicines, dietary supplements, vitamins, etc.) within one week prior to admission (or 5 times the half-life, whichever is longer), or who will be required to take such drugs by the end of the examination.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Hospital Tokyo

Shinjuku-ku, Tokyo, 160-0004, Japan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Akihisa Mori, PhD

    SNLD, Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2024

First Posted

June 11, 2024

Study Start

May 10, 2024

Primary Completion

September 20, 2024

Study Completion

September 20, 2024

Last Updated

February 7, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)