Phase 1
Completed N=97
Study Of PF-06817024 In Healthy Subjects, In Patients With Chronic Rhinosinusitis With Nasal Polyps And in Patients With Atopic Dermatitis
Source: ClinicalTrials.gov NCT02743871 ↗Enrolled (actual)
97
Serious AEs
6.2%
Results posted
May 2022
Primary outcomePrimary: Number of Participants With All-causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part 1 — 6; 4; 5; 3 Participants
Summary
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06817024 in healthy volunteers, in participants with chronic rhinosinusitis, with nasal polyps and in participants with moderate-to-severe Atopic Dermatitis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With All-causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part 1 |
6; 4; 5; 3; 1; 6 | — |
| PRIMARY Number of Participants With Treatment-Related TEAEs and SAEs in Part 1 |
2; 2; 2; 2; 1; 3 | — |
| PRIMARY Number of All-Causality TEAEs According to Severity in Part 1 |
14; 10; 20; 11; 4; 15 | — |
| PRIMARY Number of Participants With Permanent Discontinuation Due to TEAEs in Part 1 |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With All-Causality TEAEs and SAEs in Part 2 |
10; 8; 0; 1 | — |
| PRIMARY Number of Participants With Treatment-Related TEAEs and SAEs in Part 2 |
5; 3; 0; 0 | — |
| PRIMARY Number of All-Causality TEAEs According to Severity in Part 2 |
44; 24; 14; 9; 0; 3 | — |
| PRIMARY Number of Participants With Permanent Discontinuation Due to TEAEs in Part 2 |
0; 0 | — |
| PRIMARY Number of Participants With All-Causality TEAEs and SAEs in Part 3 |
12; 5; 3; 1 | — |
| PRIMARY Number of Participants With Treatment-Related TEAEs and SAEs in Part 3 |
5; 0; 1; 0 | — |
| PRIMARY Number of All-Causality TEAEs According to Severity in Part 3 |
12; 2; 15; 5; 13; 1 | — |
| PRIMARY Number of Participants With Permanent Discontinuation Due to TEAEs in Part 3 |
0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis in Part 1 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis in Part 2 |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis in Part 3 |
0; 0; 1; 0 | — |
| PRIMARY Number of Participants With Vital Sign Abnormalities in Part 1 |
1; 0; 1; 0; 0; 0 | — |
| PRIMARY Number of Participants With Vital Sign Abnormalities in Part 2 |
1; 0; 2; 0; 1; 0 | — |
| PRIMARY Number of Participants With Vital Sign Abnormalities in Part 3 |
1; 0; 3; 0; 2; 0 | — |
| PRIMARY Number of Participants With Electrocardiogram (ECG) Abnormalities in Part 1 |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With ECG Abnormalities in Part 2 |
1; 2; 1; 1 | — |
| PRIMARY Number of Participants With ECG Abnormalities in Part 3 |
2; 2; 5; 2; 1; 0 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) of PF-06817024 Following Single Dose in Part 1 |
2.879; 12.26; 2.471; 35.56; 97.49; 313.2 | — |
| SECONDARY Cmax of PF-06817024 Following Multiple Doses in Part 1 |
35.35; NA; 41.32 | — |
| SECONDARY Cmax of PF-06817024 in Part 2 |
107.1 | — |
| SECONDARY Cmax of PF-06817024 in Part 3 |
197.3; 165.9; 190.7; 199.8 | — |
| SECONDARY Dose Normalized Maximum Observed Serum Concentration (Cmax[dn]) of PF-06817024 Following Single Dose in Part 1 |
0.2879; 0.4091; 0.08230; 0.3556; 0.3249; 0.3132 | — |
| SECONDARY Cmax(dn) of PF-06817024 Following Multiple Doses in Part 1 |
0.3535; NA; 0.4132 | — |
| SECONDARY Cmax(dn) of PF-06817024 in Part 2 |
0.3569 | — |
| SECONDARY Cmax(dn) of PF-06817024 in Part 3 |
0.3306; 0.5544; 0.6361; 0.6663 | — |
| SECONDARY Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-06817024 Following Single Dose in Part 1 |
4.00; 1.76; 338; 1.07; 2.00; 1.775 | — |
| SECONDARY Tmax of PF-06817024 Following Multiple Doses in Part 1 |
2.010; NA; 1.550 | — |
| SECONDARY Tmax of PF-06817024 in Part 2 |
2.00 | — |
| SECONDARY Tmax of PF-06817024 in Part 3 |
2.03; 1.70; 1.75; 1.76 | — |
| SECONDARY Area Under the Curve From Time Zero to Infinity Concentration (AUCinf) of PF-06817024 Following Single Dose in Part 1 and 2 |
4384; 14640; 8646; 44460; 116700; 427100 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06817024 Following Single Dose in Part 1 and 2 |
4075; 14070; 8333; 43510; 116000; 425700 | — |
| SECONDARY Area Under the Curve Within Dosing Interval (AUCtau) of PF-06817024 Following Multiple Doses in Part 1 |
10580; NA; 16210 | — |
| SECONDARY AUCtau of PF-06817024 in Part 3 |
58350; 77550; 90340; 92230 | — |
| SECONDARY Dose Normalized Area Under the Curve Within Dosing Interval (AUCtau[dn]) of PF-06817024 Following Multiple Doses in Part 1 |
105.8; NA; 162.1 | — |
| SECONDARY AUCtau(dn) of PF-06817024 Following Multiple Doses in Part 3 |
97.98; 259.1; 301.1; 307.3 | — |
| SECONDARY Average Concentration Over Dosing Interval (Cav) of PF-06817024 Following Multiple Doses in Part 1 |
14.70; NA; 22.55 | — |
| SECONDARY Cav of PF-06817024 Following Multiple Doses in Part 3 |
86.78; 115.4; 134.4; 137.2 | — |
| SECONDARY Terminal Elimination Half Life (t1/2) of PF-06817024 Following Single Dose in Part 1 |
91.34; 88.88; 97.17; 83.70; 83.33; 93.90 | — |
| SECONDARY t1/2 of PF-06817024 Following Multiple Doses in Part 1 |
NA; 98.87 | — |
| SECONDARY t1/2 of PF-06817024 in Part 2 |
85.68 | — |
| SECONDARY t1/2 of PF-06817024 in Part 3 |
75.98 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) of PF-06817024 for the Subcutaneous Cohort in Part 1 |
11.60 | — |
| SECONDARY Apparent Clearance (CL/F) of PF-06817024 for the Subcutaneous Cohort in Part 1 |
0.003470 | — |
| SECONDARY Volume of Distribution at Steady State (Vss) of PF-06817024 Following Single Intravenous Dose in Part 1 and Part 2 |
6.949; 5.929; 6.449; 6.863; 7.260; 6.250 | — |
| SECONDARY Clearance (CL) of PF-06817024 Following Single Intravenous Dose in Part 1 and Part 2 |
0.00228; 0.00205; 0.002249; 0.002574; 0.002341; 0.002053 | — |
| SECONDARY Trough Serum Concentration (Cmin) of PF-06817024 Post Second Dose Following Multiple Doses in Part 1 |
NA; 9.851 | — |
| SECONDARY Cmin of PF-06817024 Post Last Dose Following Multiple Doses in Part 3 |
81.1 | — |
| SECONDARY Accumulation Ratio for Cmax (Rac, Cmax) of PF-06817024 Post Second Dose Following Multiple Doses in Part 1 |
NA; 1.106 | — |
| SECONDARY Rac, Cmax of PF-06817024 Post Last Dose Following Multiple Doses in Part 3 |
2.005 | — |
| SECONDARY Accumulation Ratio for AUCtau (Rac) of PF-06817024 Post Second Dose Following Multiple Doses in Part 1 |
NA; 1.499 | — |
| SECONDARY Rac of PF-06817024 Post Last Dose Following Multiple Doses in Part 3 |
3.163 | — |
| SECONDARY Number of Participants With Treatment-Induced Anti-Drug Antibody (ADA) Against PF-06817024 in Part 1, 2, and 3 |
0; 0; 1; 0; 2; 0 | — |
| SECONDARY Number of Participants With Treatment-Induced Neutralizing Antibodies (NAbs) Against PF-06817024 in Part 1, 2, and 3 |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male subjects, healthy female subjects of non-childbearing potential, 18-55 years of age (Part 1)
- Male subjects, female subjects of non-childbearing potential, female subjects of childbearing potential with documented bilateral tubal ligation (tubes tied) or bilateral salpingectomy (tubes removed), 18-65 years of age, and 2 of the following symptoms: nasal congestion/obstruction, nasal discharge, face pain/pressure,or reduction/loss of smell (Part 2)
- Male or female subjects between the ages of 18 and 75 years, inclusive with moderate-to-severe Atopic Dermatitis, agree to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps, or other ultraviolet light sources during the study (Part 3)
Exclusion Criteria
- Clinically significant diseases (cardiac, psychiatric, autoimmune, renal, etc.), positive urine drug test, fever within 7 days of dosing, active infections within 28 days of dosing (Part 1 and 2 and 3)
- History of allergic reaction to topical lidocaine, nasal surgery within 6 months (Part 2)
- Exposure to live or attenuated vaccines, have skin conditions other than Atopic Dermatitis, use of JAK inhibitors and biologics (Part 3)
Data sourced from ClinicalTrials.gov (NCT02743871). 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.