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Completed

NCT Number: NCT05347849

Single Ascending Dose Study With BPL-003 in Healthy Subjects

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

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Key information

Conditions

Pharmacokinetics in Healthy Adults

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hammersmith Medicines Research

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BPL-003

Drug

A single dose of BPL-003 will be administered intranasally

Placebo

Other

A single dose of placebo will be administered intranasally

Primary outcomes

  1. Percentage of subjects with treatment emergent AEs (TEAES)

    Time frame: From screening through to the follow up visit, up to 65 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Beckley Psytech Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 26, 2022
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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