Pharmacokinetic Study of DA-020

Early Phase 1Not Yet RecruitingNCT07402330

Applied Biology, Inc.60 enrolled

Overview

A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of DA-020

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chemotherapy Induced Alopecia Chemotherapy Side Effects

Interventions

DA-020 (0.1%)DRUG

DA-020 (0.1%)

DA-020 (0.2%)DRUG

DA-020 (0.2%)

DA-020 (0.5%)DRUG

DA-020 (0.5%)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy females, age 18-55 * BMI: 18-30 kg/m² * Fitzpatrick Skin Types I-IV (to standardize absorption risk) * Scalp free from irritation, dermatologic disease, or damage * Able to refrain from using other topical scalp products Exclusion Criteria: * History of cardiovascular disease, hypertension, or arrhythmia * Scalp infections, wounds, or significant hair loss * Recent use of medications that interfere with CYP enzymes or adrenergic systems * Known sensitivity to phenylephrine or ethanol * Positive drug screen or abnormal ECG at screening

Locations (2)

Hospital Samel

Manaus, Brazil

University of Rome ("G. Marconi")

Rome, Italy

Outcomes

Primary Outcomes

Concentration of DA-020 in Serum

Determine the amount of Oxymetazoline in serum after 1 time scalp application

Time frame: Hours [0, 1, 2, 4, 8, 12, 24]

Secondary Outcomes

Safety and tolerability of DA-020

Determine blood pressure following a single application of DA-020

Time frame: Hours [0, 1, 2, 4, 8, 12, 24]

Central Contacts

Andy Goren, MD

CONTACT

16507040850 clinicalstudies@appliedbiology.com

Data from ClinicalTrials.gov

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