FIH Study to Evaluate the Tolerability of PF-07832837 in Healthy Adults and Patients
NCT Number: NCT06564389
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Participants|Atopic Dermatitis
Interventions: DRUG: PF-07832837|OTHER: Placebo
Sponsor: Pfizer
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 143
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-17
Completion Date: 2026-09-09

Summary:
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating single and repeat doses of PF-07832837 in healthy participants and in participants with moderate to severe atopic dermatitis. An additional goal is to assess the pharmacodynamics (PD) of PF-07832837 in participants with moderate to severe AD, including potential effects on clinical signs and symptoms

Primary Outcome Measures: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and serious adverse events (SAEs) Following single ascending doses (SAD), Baseline up to Day 29|Number of Participants with Clinically significant Laboratory Abnormalities Following SAD, Baseline up to Day 29|Number of Participants with Change from Baseline in Electrocardiogram (ECG) Findings Following SAD, Baseline up to Day 29|Number of Participants with Clinically Significant Change from Baseline in Vital Signs Following SAD, Baseline up to Day 29|Number of Participants with Clinically Significant Change from Baseline in Cardiac Telemetry Findings Following SAD, Day 1|Number of Participants With Treatment Emergent Treatment-Related AEs and SAEs Following multiple ascending doses (MAD), Baseline up to Day 43|Number of Participants with Clinically significant Laboratory Abnormalities Following MAD, Baseline up to Day 43|Number of Participants with Change from Baseline in Electrocardiogram (ECG) Findings Following MAD, Baseline up to Day 43|Number of Participants With Treatment Emergent Treatment-Related AEs and SAEs in participants with atopic dermatitis (AD), Baseline up to Day 85|Number of Participants with Clinically significant Laboratory Abnormalities in participants with AD, Baseline up to Day 85|Number of Participants with Change from Baseline in Electrocardiogram (ECG) Findings in participants with AD, Baseline up to Day 85|Number of Participants with Clinically Significant Change from Baseline in Vital Signs in participants with AD, Baseline up to Day 85
Secondary Outcome Measures: Area Under the Curve From Time Zero to Last (AUClast) of PF-07832837 following SAD, Day 1 to Day 29|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07832837 following SAD, Day 1 to Day 29|Maximum Observed Serum Concentration (Cmax) of PF-07832837 following SAD, Day 1 to Day 29|Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07832837 following SAD, Day 1 to Day 29|Terminal serum elimination half life (t1/2) of PF-07832837 following SAD, Day 1 to Day 29|Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of PF-07832837 following MAD, Day 1 to Day 43|Maximum Observed Serum Concentration (Cmax) of PF-07832837 following MAD, Day 1 to Day 43|Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07832837 following MAD, Day 1 to Day 43|Percent change from baseline in Eczema Area and Severity Index (EASI) total score at Week 8, EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD., Baseline, Week 8