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NCT06303648
A Single, Ascending Dose Evaluation of the Safety, Pharmacokinetics of Methylone in Healthy Subjects
Phase 1 trial testing Methylone in Post Traumatic Stress Disorder in 40 participants. Completed in 13 July 2025.
13 July 2025
Quick facts
| Lead sponsor | Transcend Therapeutics |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 20 March 2024 |
| Primary completion | 13 July 2025 |
| Estimated completion | 13 July 2025 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- Methylone — full drug profile →
- Placebo
Conditions studied
- Post Traumatic Stress Disorder — all drugs for Post Traumatic Stress Disorder →
Sponsor
Transcend Therapeutics — full company profile →
Who can join
Adults 25 to 55, any sex, with Post Traumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open-label, single, ascending dose study evaluating the PK and safety of methylone in healthy subjects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06303648
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Methylone
Trials testing the same drug.
- NCT06215261 — An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD · Phase 2 · completed
- NCT06237426 — An Evaluation of the Long-term Efficacy and Safety of Methylone for the Treatment of PTSD · Phase 2 · completed
- NCT05741710 — A Study to Assess the Use of Methylone in the Treatment of PTSD · Phase 1, PHASE2 · completed
- NCT05488171 — Abuse Potential and Human Pharmacology of Methylone · Phase 1 · unknown
Other recruiting trials for Post Traumatic Stress Disorder
Currently open trials in the same condition.
- NCT07485231 — Nitric Oxide (NO) and Endothelial Dysfunction in Women With PTSD · NA · recruiting
- NCT07316088 — Determining the Potential for Efficacy of OTX-601 in Reducing PTSD Symptoms · Phase 2 · recruiting
- NCT07227337 — Being Safe, Healthy, And Positively Empowered (BSHAPE) Intervention Study · NA · recruiting
- NCT06988787 — Multifaceted Intervention to Restore Resilience and Overcome Risk · NA · recruiting
- NCT06740487 — Advanced Wireless Augmented Reality-Enhanced Exposure Therapy for Posttraumatic Stress Disorder · NA · recruiting
Other Transcend Therapeutics trials
Trials by the same sponsor.
- NCT06215261 — An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD · Phase 2 · completed
- NCT06237426 — An Evaluation of the Long-term Efficacy and Safety of Methylone for the Treatment of PTSD · Phase 2 · completed
- NCT05741710 — A Study to Assess the Use of Methylone in the Treatment of PTSD · Phase 1, PHASE2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06303648 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Transcend Therapeutics
- Last refreshed: 9 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06303648.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing