Single Ascending Dose Study With BPL-003 in Healthy Subjects

Phase 1

Completed

• Conditions: Pharmacokinetics in Healthy Adults
• Interventions: Drug: BPL-003; Other: Placebo

• Registration Number: NCT05347849
• Lead Sponsor: Beckley Psytech Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-14
• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-26
• Primary Completion: 2024-01-19
• Study Completion: 2024-01-19
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
BPL-003 arm	BPL-003	-
Placebo arm	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hammersmith Medicines Research; 🇬🇧 London, United Kingdom