Parkinson DiseasePhase 1NCT06453551
A Phase I Study of TRN501 in Healthy Volunteers
A Phase 1 study testing TRN501 - Dose 1, TRN501 - Dose 2 and TRN501 - Dose 3 in people with Parkinson Disease, run by SNLD, Ltd. at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- TRN501 - Dose 1, TRN501 - Dose 2 and TRN501 - Dose 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteJapan
- Study dates
- 10 May 2024to 20 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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.
- Smokers, or those who have quit smoking within 6 months prior to admission.
- Persons with a history of drug abuse or alcohol dependence, or complications.
- Those who have collected 400 mL or more of blood within 12 weeks prior to admission or 200 mL or more of blood within 4 weeks through blood donation, etc.
- Who received all other unapproved drugs (including investigational drugs, drugs administered through clinical research, unapproved combination drugs, and new dosage forms) within 3 months (or 5 times the half-life, whichever is longer) prior to the administration of the investigational drug. However, even if the period is longer than this, those who have been judged by the investigator to be inappropriate to participate in this study in consideration of the characteristics of the previous study drug.
- Those who are positive for either syphilis seroreaction, HBs (hepatitis B) antigen, HCV (hepatitis C virus) antibody, or HIV antigen/antibody at the time of screening.
- Others who are judged by the investigator to be unsuitable as participants for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Evaluate the Safety and Pharmacokinetics of TRN501 in Healthy Adult Japanese Male Volunteers
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.
- Conditions
- Parkinson Disease
- Being tested
- TRN501 - Dose 1, TRN501 - Dose 2, TRN501 - Dose 3, TRN501 - Dose 4, TRN501 - Dose 5
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
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.
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.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Single dose 1 | Experimental | TRN501 - Dose 1 Receives: Drug: TRN501 - Dose 1 |
| Single dose 2 | Experimental | TRN501 - Dose 2 Receives: Drug: TRN501 - Dose 2 |
| Single dose 3 | Experimental | TRN501 - Dose 3 Receives: Drug: TRN501 - Dose 3 |
| Single dose 4 | Experimental | TRN501 - Dose 4 Receives: Drug: TRN501 - Dose 4 |
| Single dose 5 | Experimental | TRN501 - Dose 5 Receives: Drug: TRN501 - Dose 5 |
| Single dose 6 | Experimental | TRN501 - Dose 6 Receives: Drug: TRN501 - Dose 6 |
| Single dose 7 | Experimental | TRN501 - Dose 7 Receives: Drug: TRN501 - Dose 7 |
| Single dose 8 | Experimental | TRN501 - Dose 8 Receives: Drug: TRN501 - Dose 8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: For each cohort, the day of entry (Day -1) and the day of leaving the facility (Day 2 or at the time of discontinuation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start10 May 2024
- Primary completion20 Sep 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- SNLD, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Akihisa Mori, PhD, Study director, SNLD, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453551
- Sponsor's protocol ID
- TRN501-PD101
- Status last verified
- Feb 2025
- First submitted
- 21 May 2024
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety and Pharmacokinetics of TRN501 in Healthy Adult Japanese Male Volunteers
- ClinicalTrials.gov ID
- NCT06453551
- Acronym / sponsor ID
- TRN501-PD101
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- SNLD, Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 May 2024 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Single dose 1 | Experimental | Drug: TRN501 - Dose 1TRN501 - Dose 1 |
| Single dose 2 | Experimental | Drug: TRN501 - Dose 2TRN501 - Dose 2 |
| Single dose 3 | Experimental | Drug: TRN501 - Dose 3TRN501 - Dose 3 |
| Single dose 4 | Experimental | Drug: TRN501 - Dose 4TRN501 - Dose 4 |
| Single dose 5 | Experimental | Drug: TRN501 - Dose 5TRN501 - Dose 5 |
| Single dose 6 | Experimental | Drug: TRN501 - Dose 6TRN501 - Dose 6 |
| Single dose 7 | Experimental | Drug: TRN501 - Dose 7TRN501 - Dose 7 |
| Single dose 8 | Experimental | Drug: TRN501 - Dose 8TRN501 - Dose 8 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRN501 - Dose 1Each 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. | Drug | Single dose 1 |
| TRN501 - Dose 2Each 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. | Drug | Single dose 2 |
| TRN501 - Dose 3Each 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. | Drug | Single dose 3 |
| TRN501 - Dose 4Each 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. | Drug | Single dose 4 |
| TRN501 - Dose 5Each 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. | Drug | Single dose 5 |
| TRN501 - Dose 6Each 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. | Drug | Single dose 6 |
| TRN501 - Dose 7Each 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. | Drug | Single dose 7 |
| TRN501 - Dose 8Each 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. | Drug | Single dose 8 |
Primary outcome
Safety evaluation of TRN501: Incidents of Treatment-Emergent Adverse Events
Time frame: 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.
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.
Safety evaluation of TRN501: Incidents of physical findings
Time frame: 3 days and 2 nights (for each cohort)
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.
Safety evaluation of TRN501: Vital sign (body temperature)
Time frame: 3 days and 2 nights (for each cohort)
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.
Safety evaluation of TRN501: Vital sign (blood pressure)
Time frame: 3 days and 2 nights (for each cohort)
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.
Safety evaluation of TRN501: Vital sign (pulse rate)
Time frame: 3 days and 2 nights (for each cohort)
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.
Safety evaluation of TRN501: Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: For each cohort, the day of entry (Day -1) and the day of leaving the facility (Day 2 or at the time of discontinuation).
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.
Safety evaluation of TRN501: Incidents of participants with laboratory abnormality
Time frame: For each cohort, the day of entry (Day -1) and the day of leaving the facility (Day 2 or at the time of discontinuation).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akihisa Mori, PhD study director
SNLD, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TRN501 - Dose 1, TRN501 - Dose 2 and TRN501 - Dose 3 in people with Parkinson Disease, run by SNLD, Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety evaluation of TRN501: Incidents of Treatment-Emergent Adverse Events (time frame: 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.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.