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NCT05698095 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics, Safety, and Tolerability of Intramuscular 5-MeO-DMT in Healthy Volunteers
A Phase 1 study, sponsored by Usona Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT05698095: Completed Phase 1 study, sponsored by Usona Institute.
NCT05698095 is a Phase 1 study that has completed, run by Usona Institute. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05698095, a Phase 1 study, has completed, sponsored by Usona Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Number of participants with TEAEs following administration of 5-MeO-DMT.
Interventions
- DRUG Placebo
- DRUG 5-methoxy-N,N-dimethyltryptamine succinate salt
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2022-12-27 |
| Est. Completion | 2023-09-07 |
| Phase | Phase 1 |
What the finished NCT05698095 record still lists
NCT05698095 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05698095 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05698095 about?
NCT05698095 is a clinical study titled "Pharmacokinetics, Safety, and Tolerability of Intramuscular 5-MeO-DMT in Healthy Volunteers". 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.
What is the current status of trial NCT05698095?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2022-12-27. Estimated completion is 2023-09-07.
What interventions are being tested in trial NCT05698095?
The interventions under investigation include: Placebo (DRUG), 5-methoxy-N,N-dimethyltryptamine succinate salt (DRUG).
Who is sponsoring clinical trial NCT05698095?
This trial is sponsored by Usona Institute, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05698095's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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