Single ascending dose study with BPL-003 in healthy subjects

A two-part phase 1, single ascending dose study to evaluate the safety, tolerability and pharmacokinetic profile of intranasal BPL-003 (5-Methoxy-N,N dimethyltryptamine Benzoate) in healthy subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10271810

Enrollment

Registered

2022-01-26

Start date

2022-02-02

Completion date

Unknown

Last updated

2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The study will evaluate safety, tolerability and PK profile of BPL-003 in healthy subjects Other

Interventions

Drug/ BPL-003 arm: BPL-003 - A single dose of BPL-003 will be administered intranasally. Placebo Comparator arm: Placebo - A single dose of placebo will be administered intranasally. Allocation: Rando

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Medically healthy based on medical records and study specific assessments.

Exclusion criteria

Exclusion criteria: Presence or history of severe adverse reaction to any drug or drug excipient.

Design outcomes

Primary

Measure	Time frame
Percentage of subjects with treatment emergent AEs (TEAES) [Time Frame: From screening through to the follow up visit, up to 65 days].	—

Secondary

Measure	Time frame
1. Peak plasma concentration (Cmax) [Time Frame: Day 1 (dosing day) and Day 2] 2. Time to reach Cmax (tmax) [Time Frame: Day 1 (dosing day) and Day 2] 3. Area under the plasma concentration- time curve [Time Frame: Day 1 (dosing day) and Day 2]	—

Countries

England, United Kingdom

Contacts

Public Contact. Beckley Psytech Ltd.

medinfo@beckleypsytech.com-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026