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

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05347849

Enrollment

Registered

2022-04-26

Start date

2022-02-14

Completion date

2024-01-19

Last updated

2024-03-18

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

Conditions

Pharmacokinetics in Healthy Adults

Brief summary

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

Interventions

DRUGBPL-003

A single dose of BPL-003 will be administered intranasally

OTHERPlacebo

A single dose of placebo will be administered intranasally

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Part A only

Eligibility

Sex/Gender

ALL

Age

25 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Medically healthy based on medical records and study specific assessments

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)	From screening through to the follow up visit, up to 65 days

Secondary

Measure	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	Day 1 (dosing day) and Day 2

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026