Study to Evaluate the Safety, Local and Systemic Tolerability, and Pharmacokinetics of Multiple-Dose Topical Administration of PF-07038124 in Japanese Healthy Participants

Phase 1

• Conditions: Atopic Dermatitis and Psoriasis

• Registration Number: JPRN-jRCT2031210127
• Lead Sponsor: Kawai Norisuke

Brief Summary

Safety: All PF-07038124 topical doses [0.01% once daily (QD) in 2000 cm2 of skin area and 0.01% QD in 4000 cm2 of skin area] were generally safe and well-tolerated both locally and systemically in Japanese healthy participants. PK: All concentrations were BLQ on Day 1, Day 4, and Day 7. The majority of concentrations were BLQ on Day 10: up to 24 hours postdose, >93% and 65% of plasma PK samples of PF-07038124 were BLQ for PF-07038124 2000 cm2 treatment and PF-07038124 4000 cm2 treatment, respectively.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-31
• Study Completion: 2021-10-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Inclusion Criteria:
1.Male and female participants must be 20 to 55 years of age, inclusive, at the time of signing the ICD.
2.Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12-lead ECG.
3.Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
4.Participants must have 4 biologically Japanese grandparents who were born in Japan.
5.BMI of 17.5 to 25 kg/m2; and a total body weight >50 kg (110 lb).
6.Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Exclusion Criteria

Exclusion Criteria:
1.Participants who have any visible skin damage or skin condition (eg, sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations) in or around the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction.
2.Participants who have a history of or have active forms of dermatitides/eczematous conditions (eg, contact dermatitis, seborrhhoeic, discoid, gravitational, asteatotic and dishydrotic eczema) or other inflammatory skin diseases(eg, psoriasis, viral infection, fungal infection, bacterial infection) that would interfere with evaluation of the test site reaction.
3.Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
4.History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBcAb, HCVAb, or syphilis at screening. Hepatitis B vaccination is allowed.
5.Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
6.Acute disease state (unstable medical condition such as nausea, vomiting, fever or diarrhea, etc) within 7 days of Day 1.
7.Have undergone significant trauma or major surgery within 4 weeks of screening.
8.Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
9.Previous administration with an investigational drug within 4 months (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
10.A positive urine drug test at screening and/or Day -1.
11.Screening supine BP >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of supine rest.
12.Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline QTcF interval >450 msec, complete LBBB, signs of an acute or indeterminate age myocardial infarction, ST T interval changes suggestive of myocardial ischemia, second or third degree AV block, or serious bradyarrhythmia's or tachyarrhythmias).
13.Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
*AST or ALT level >=1.5 * ULN;
*Total bilirubin level >=1.5 * ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is <=ULN.
14.A positive COVID-19 test at screening.
15.History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% sp

Study & Design

• Study Type: Interventional
• Study Design: Not specified