CompletedNCT05347849Updated Mar 18, 2024

Single Ascending Dose Study With BPL-003 in Healthy Subjects

A Phase 1 interventional study of BPL-003 and Placebo in Pharmacokinetics in Healthy Adults, sponsored by Beckley Psytech Limited. Completed at 1 site in United Kingdom. Open to participants aged 25 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-18.

Sponsored by Beckley Psytech Limited · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 62
Allocation: Randomized
Ages: 25 Years to 55 Years
Sex: All

Study summary

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

Conditions studied

Pharmacokinetics in Healthy Adults

In context

Lead sponsor

Beckley Psytech Limited is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 25 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 62 participants (actual)

Study arms

Experimental
BPL-003 arm
Drug: BPL-003
Placebo comparator
Placebo arm
Other: Placebo

Interventions

DrugBPL-003
A single dose of BPL-003 will be administered intranasally
OtherPlacebo
A single dose of placebo will be administered intranasally

What researchers measure

Primary outcomes

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

Secondary outcomes

Peak plasma concentration (Cmax)
Time frame: Day 1 (dosing day) and Day 2
Time to reach Cmax (tmax)
Time frame: Day 1 (dosing day) and Day 2
Area under the plasma concentration- time curve
Time frame: Day 1 (dosing day) and Day 2

Study locations

1 site

Hammersmith Medicines Research
London, United Kingdom

References and documents

Individual participant data

Plan to share: No — Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05347849
Lead sponsor: Beckley Psytech Limited
Responsible party: Sponsor
First posted: Apr 26, 2022
Start date: Feb 14, 2022
Primary completion: Jan 19, 2024
Completion: Jan 19, 2024
Last update: Mar 18, 2024

Study contacts

VP & Head of Clinical Development, PhD

study director · Beckley Psytech Ltd

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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