Single Ascending Dose Study With BPL-003 in Healthy Subjects

Phase 1CompletedNCT05347849

Beckley Psytech Limited62 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pharmacokinetics in Healthy Adults

Interventions

BPL-003DRUG

A single dose of BPL-003 will be administered intranasally

PlaceboOTHER

A single dose of placebo will be administered intranasally

Eligibility

Sex: ALLMin age: 25 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hammersmith Medicines Research

London, United Kingdom

Outcomes

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

Data from ClinicalTrials.gov

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