Single Ascending Dose Study With BPL-003 in Healthy Subjects

NCT ID: NCT05347849

Last Updated: 2024-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-14

Study Completion Date

2024-01-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pharmacokinetics in Healthy Adults

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Part A only

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BPL-003 arm

Group Type EXPERIMENTAL

BPL-003

Intervention Type DRUG

A single dose of BPL-003 will be administered intranasally

Placebo arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

A single dose of placebo will be administered intranasally

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BPL-003

A single dose of BPL-003 will be administered intranasally

Intervention Type DRUG

Placebo

A single dose of placebo will be administered intranasally

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beckley Psytech Limited

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

VP & Head of Clinical Development, PhD

Role: STUDY_DIRECTOR

Beckley Psytech Ltd

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hammersmith Medicines Research

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38616411 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BPL-003-103

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

IAMA-6 Oral Dose Study in Healthy Adults
NCT06300398 RECRUITING PHASE1
Single and Repeat Doses of DMT in Healthy Subjects
NCT05559931 ACTIVE_NOT_RECRUITING PHASE1
Methamphetamine and Troriluzole
NCT06989853 RECRUITING EARLY_PHASE1