NCT05347849

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2024

Completed
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

1.9 years

First QC Date

April 21, 2022

Last Update Submit

March 14, 2024

Conditions

Pharmacokinetics in Healthy Adults

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects with treatment emergent AEs (TEAES)

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

Secondary Outcomes (3)

  • 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

Study Arms (2)

BPL-003 arm

EXPERIMENTAL
Drug: BPL-003

Placebo arm

PLACEBO COMPARATOR
Other: Placebo

Interventions

BPL-003DRUG

A single dose of BPL-003 will be administered intranasally

BPL-003 arm
PlaceboOTHER

A single dose of placebo will be administered intranasally

Placebo arm

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Medically healthy based on medical records and study specific assessments

You may not qualify if:

  • Presence or history of severe adverse reaction to any drug or drug excipient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hammersmith Medicines Research

London, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 38616411DERIVED

Study Officials

  • VP & Head of Clinical Development, PhD

    Beckley Psytech Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Part A only
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2022

First Posted

April 26, 2022

Study Start

February 14, 2022

Primary Completion

January 19, 2024

Study Completion

January 19, 2024

Last Updated

March 18, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion

Locations

GB(1)