Post Traumatic Stress DisorderPhase 1NCT06303648
A Single, Ascending Dose Evaluation of the Safety, Pharmacokinetics of Methylone in Healthy Subjects
A Phase 1 study testing Methylone in people with Post Traumatic Stress Disorder, run by Transcend Therapeutics at 1 site in Australia.
Trial summary
This is an open-label, single, ascending dose study evaluating the PK and safety of methylone in healthy subjects. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Methylone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 20 Mar 2024to 13 Jul 2025
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male or female aged 25 to 55 inclusive
- Normal resting ECG
- Normal hematologic and hepatic function
- Normal renal function
Who cannot join
- Vital sign abnormalities
- Positive urine drug screen at screening and / or Day -1
- Current mental illness such as depression, anxiety disorder, schizophrenia or other psychotic disorders
Trial locations and contacts
1 site in 1 country.
About this study
This is an open-label, single, ascending dose study evaluating the PK and safety of methylone in healthy subjects.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Methylone, Placebo
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethyloneDrug
Oral dose of methylone
PlaceboDrug
Placebo to match methylone
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 50 mg x 1 dose Receives: Drug: Methylone |
| Cohort 2 | Experimental | 100 mg x 1 dose Receives: Drug: Methylone |
| Cohort 3 | Experimental | 150 mg x 1 dose Receives: Drug: Methylone |
| Cohort 4 | Experimental | 200 mg x 1 dose Receives: Drug: Methylone |
| Cohort 5 | Experimental | 150 mg + 100 mg x 1 Receives: Drug: Methylone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax: Maximum Observed Plasma Concentration for methylone
Measured: 48 hours following the dose
AUC: Area under the plasma concentration-time curve for methylone
Measured: 48 hours following the dose
Secondary outcomes (1)
Incidence and frequency of adverse events
Measured: 10 days after the dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start20 Mar 2024
- Primary completion13 Jul 2025
- Study completion13 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Subjects will be enrolled into one of four cohorts. The study will begin enrolling Cohort 1.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transcend Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303648
- Sponsor's protocol ID
- TSND201-PK-101
- Status last verified
- Sep 2025
- First submitted
- 20 Feb 2024
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single, Ascending Dose Evaluation of the Safety, Pharmacokinetics of Methylone in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06303648
- Acronym / sponsor ID
- TSND201-PK-101
- Conditions
- Post Traumatic Stress Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Transcend TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 13 Jul 2025 (actual)
- Study completion
- 13 Jul 2025 (actual)
- First posted
- 12 Mar 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.
This is an open-label, single, ascending dose study evaluating the PK and safety of methylone in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Subjects will be enrolled into one of four cohorts. The study will begin enrolling Cohort 1.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Methylone50 mg x 1 dose |
| Cohort 2 | Experimental | Drug: Methylone100 mg x 1 dose |
| Cohort 3 | Experimental | Drug: Methylone150 mg x 1 dose |
| Cohort 4 | Experimental | Drug: Methylone200 mg x 1 dose |
| Cohort 5 | Experimental | Drug: Methylone, Drug: Placebo150 mg + 100 mg x 1 |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult male or female aged 25 to 55 inclusive
- Normal resting ECG
- Normal hematologic and hepatic function
- Normal renal function
Key exclusion criteria (3 listed)
- Vital sign abnormalities
- Positive urine drug screen at screening and / or Day -1
- Current mental illness such as depression, anxiety disorder, schizophrenia or other psychotic disorders
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 |
|---|---|---|
| MethyloneOral dose of methylone | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| PlaceboPlacebo to match methylone | Drug | Cohort 5 |
Primary outcome
Cmax: Maximum Observed Plasma Concentration for methylone
Time frame: 48 hours following the dose
AUC: Area under the plasma concentration-time curve for methylone
Time frame: 48 hours following the dose
1 secondary outcome
Incidence and frequency of adverse events
Time frame: 10 days after the dose
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 9 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Methylone in people with Post Traumatic Stress Disorder, run by Transcend Therapeutics at 1 site in Australia.
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 4 inclusion and 3 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 9 Sep 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 Australia. 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?
Cmax: Maximum Observed Plasma Concentration for methylone (time frame: 48 hours following the dose). The study lists 2 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 9 Sep 2025.