Single Ascending Dose Study With BPL-003 in Healthy Subjects

Pharmacokinetics in Healthy Adults Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05347849
• Other study ID #: BPL-003-103
• Status: Completed
• Phase: Phase 1
• Start date: February 14, 2022
• Est. completion date: January 19, 2024

Study information

• Verified date: March 2024
• Source: Beckley Psytech Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 19, 2024
• Est. primary completion date: January 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharmacokinetics in Healthy Adults

Intervention

Drug:
• BPL-003
A single dose of BPL-003 will be administered intranasally

Other:
• Placebo
A single dose of placebo will be administered intranasally

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research	London

Sponsors (1)

Lead Sponsor	Collaborator
Beckley Psytech Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with treatment emergent AEs (TEAES)		From screening through to the follow up visit, up to 65 days
Secondary	Peak plasma concentration (Cmax)		Day 1 (dosing day) and Day 2
Secondary	Time to reach Cmax (tmax)		Day 1 (dosing day) and Day 2
Secondary	Area under the plasma concentration- time curve		Day 1 (dosing day) and Day 2