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Phase 1 Completed N=24 Randomized Triple-blind Treatment

A First-in-human Study of Multiple Doses of Topically Administered PF-07295324 and PF-07259955

Healthy
Source: ClinicalTrials.gov NCT05206604 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 3; 1; 1; 1 Participants

Summary

The purpose of the study is to evaluate the safety, (local and systemic) tolerability, and pharmacokinetics following multiple doses of topically applied, maximum feasible formulations of PF-07295324 (0.12% w/w) or PF-07259955 (2% w/w), on approximately 20% body surface area (BSA), in healthy adult participants.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
3; 1; 1; 1; 3; 2
PRIMARY
Number of Participants With Laboratory Abnormalities
0; 0; 0; 0; 0; 0
PRIMARY
Number of Participants With Vital Signs Abnormalities
1; 0; 0; 0; 0; 0
PRIMARY
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings
0; 0; 0; 0; 0; 0
PRIMARY
Skin Irritation Assessments Using Draize Scoring
2; 2; 4; 2; 4; 2
SECONDARY
Maximum Observed Plasma Concentration (Cmax) of PF-07295324 on Days 1 and 10
0.0001000; 0.0001000; 0.0001000; 0.001655; 0.001502; 0.002006
SECONDARY
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07295324 on Days 1 and 10
NA; NA; NA
SECONDARY
Area Under the Concentration-Time Profile From Time Zero to the Dosing Interval Tau (AUCtau) of PF-07295324 on Days 1 and 10
0.0001000; 0.0001000; 0.0001000; 0.001262; NA; 0.002037
SECONDARY
Average Plasma Concentration (Cavg) of PF-07295324 on Days 1 and 10
0.0005518; NA; 0.0007061
SECONDARY
Pre-Dose Concentration (Ctrough) of PF-07295324 on Days 1 and 10
0.0001000; 0.0001000; 0.0001000; 0.00010008; 0.0003784; 0.0004395
SECONDARY
Observed Accumulation Ratio for Cmax (Rac[Cmax]) of PF-07295324 on Day 10
SECONDARY
Observed Accumulation Ratio for AUCtau (Rac[AUCtau]) of PF-07295324 on Day 10
SECONDARY
Terminal Half-Life (t1/2) of PF-07295324 on Day 10
SECONDARY
Apparent Clearance (CL/F) of PF-07295324 on Day 10
NA; NA
SECONDARY
Apparent Volume of Distribution (Vz/F) of PF-07295324 on Day 10
SECONDARY
Cmax of PF-07259955 on Days 1 and 10
0.001161; 4.942
SECONDARY
Tmax of PF-07259955 on Days 1 and 10
8.00
SECONDARY
AUCtau of PF-07259955 on Days 1 and 10
0.0001000; 46.48
SECONDARY
Cavg of PF-07259955 on Days 1 and 10
3.873
SECONDARY
Ctrough of PF-07259955 on Days 1 and 10
0.0001000; 4.077
SECONDARY
Rac(Cmax) of PF-07259955 on Day 10
NA
SECONDARY
Rac(AUCtau) of PF-07259955 on Day 10
SECONDARY
t½ of PF-07259955 on Day 10
SECONDARY
CL/F of PF-07259955 on Day 10
3441
SECONDARY
Vz/F of PF-07259955 on Day 10

Eligibility Criteria

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

Age and Sex:

  • Healthy (except obese) female participants of non-childbearing potential and/or male participants, at the time of screening, must be 18 to 60 years of age, inclusive, at the time of signing the informed consent document (ICD).
  • Male and female of non-child bearing potential participants, who are healthy as determined by medical evaluation including medical history, physical examination, vital assessments, 12 lead ECGs, and laboratory tests.
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

Weight:

  • Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lb).
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICD and the protocol.

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

Medical Conditions:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, immunological/rheumatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • 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.
  • Participants who have a history of or have active AD/eczema/urticaria.
  • Evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by both of the following:
  • A positive QuantiFERON TB Gold In-tube or equivalent test (QFT).
  • History of either untreated or inadequately treated latent or active TB infection, or current treatment for the same.
  • History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed. As an exception a positive HBsAb test due to hepatitis B vaccination is permissible.
  • Have a history of systemic infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator within 6 months prior to Day 1.
  • A history (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.
  • Acute disease state (unstable medical condition such as nausea, vomiting, fever or diarrhea, etc) within 7 days of Day 1.
  • Have any malignancies or have a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin.
  • Have a first-degree relative with hereditary immunodeficiency.
  • A history of any lymphoproliferative disorder (such as Epstein Barr Virus [EBV] -related lymphoproliferative disorder), history of lymphoma, leukemia, malignancies or signs and symptoms suggestive of current lymphatic disease.
  • Have undergone significant trauma or major surgery within 4 weeks of screening.
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic (eg. Contact with positive case, residence, or travel to an area with high incidence) that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

Prior/Concomitant T

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05206604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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