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NCT05698095
Pharmacokinetics, Safety, and Tolerability of Intramuscular 5-MeO-DMT in Healthy Volunteers
Phase 1 trial testing 5-methoxy-N,N-dimethyltryptamine succinate salt in Pharmacokinetics in 54 participants. Completed in 7 September 2023.
7 September 2023
Quick facts
| Lead sponsor | Usona Institute |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | triple |
| Primary purpose | other |
| Enrollment | 54 |
| Start date | 27 December 2022 |
| Primary completion | 7 September 2023 |
| Estimated completion | 7 September 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- 5-methoxy-N,N-dimethyltryptamine succinate salt — full drug profile →
- Placebo
Conditions studied
- Pharmacokinetics — all drugs for Pharmacokinetics →
- Safety — all drugs for Safety →
- Tolerability — all drugs for Tolerability →
Sponsor
Usona Institute
Who can join
Adults 18 to 65, any sex, with Pharmacokinetics or Safety. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective of the study is to assess the pharmacokinetics, safety, and tolerability of a single-dose and multiple-doses of 5-MeO-DMT administered by intramuscular (IM) injections 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 NCT05698095
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT05698095 (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 Usona Institute
- Last refreshed: 30 November 2023
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/NCT05698095.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing