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The study will evaluate safety, tolerability and PK profile of BPL-003 in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BPL-003 arm | Experimental |
| |
| Placebo arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPL-003 | Drug | A single dose of BPL-003 will be administered intranasally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with treatment emergent AEs (TEAES) | From screening through to the follow up visit, up to 65 days |
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) | Day 1 (dosing day) and Day 2 | |
| Time to reach Cmax (tmax) | Day 1 (dosing day) and Day 2 | |
| Area under the plasma concentration- time curve |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| VP & Head of Clinical Development, PhD | Beckley Psytech Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38616411 | Derived | Rucker JJ, Roberts C, Seynaeve M, Young AH, Suttle B, Yamamoto T, Ermakova AO, Dunbar F, Wiegand F. Phase 1, placebo-controlled, single ascending dose trial to evaluate the safety, pharmacokinetics and effect on altered states of consciousness of intranasal BPL-003 (5-methoxy-N,N-dimethyltryptamine benzoate) in healthy participants. J Psychopharmacol. 2024 Aug;38(8):712-723. doi: 10.1177/02698811241246857. Epub 2024 Apr 14. |
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Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion
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Part A only
| Placebo |
| Other |
A single dose of placebo will be administered intranasally |
|
| Day 1 (dosing day) and Day 2 |