Phase 1
Completed N=12
Evaluation of the Pharmacokinetics, Safety and Tolerability of Single Dose of PF-06480605 in Chinese Healthy Participants
Source: ClinicalTrials.gov NCT05107492 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Maximum Observed Concentration (Cmax) of PF-06480605 — 41530 nanogram per milliliter (ng/mL)
Summary
This is a Phase 1, single-center, randomized, double-blind, third-party open (ie, participant blind, investigator blind and sponsor open), placebo controlled study to investigate PK, safety, tolerability, immunogenicity, and PD of PF 06480605 following a single subcutaneous dose of PF-06480605 450 mg and 150 mg (if needed) in Chinese healthy adult participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Concentration (Cmax) of PF-06480605 |
41530 | — |
| PRIMARY Time for Cmax (Tmax) of PF-06480605 |
96.00 | — |
| PRIMARY Area Under the Curve From Time 0 to End of Dosing Interval (AUC14day) of PF-06480605 |
11600000 | — |
| PRIMARY Area Under the Plasma Concentration Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06480605 |
31390000 | — |
| PRIMARY Terminal Half-life (t1/2) of PF-06480605 |
306.4 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
7; 3; 7; 2 | — |
| SECONDARY Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria |
0; 0 | — |
| SECONDARY Number of Participants With Change From Baseline in Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria |
0; 0 | — |
| SECONDARY Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality) |
1; 0; 0; 1; 1; 0 | — |
| SECONDARY Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06480605 |
29990000 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) of PF-06480605 |
5.839 | — |
| SECONDARY Apparent Oral Clearance (CL/F) of PF-06480605 |
0.01434 | — |
| SECONDARY Number of Participants With Positivie Anti-drug Antibody (ADA) Against PF-06480605 |
0; 1; 4; 8; 6; 7 | — |
| SECONDARY Number of Participants With Neutralizing Antibody (NAb) Against PF-06480605 |
0; 0; 0; 1; 0; 2 | — |
| SECONDARY Total Soluble Tumor Necrosis Factor Like Ligand 1A (sTL1A) Protein Concentration in Serum |
99.7; 89.7; 314.1; 110.1; 1470.3; 97.2 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female participants must be 18 to 45 years of age, inclusive, at the time of signing the ICD.
- Male and female Chinese participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital sign and 12-lead ECG
- BMI of 19 to 27 kg/m2; and a total body weight >50 kg.
Exclusion Criteria
- 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).
- History of HIV infection, hepatitis B, hepatitis C or syphilis; positive testing for HIV, hepatitis B, HCVAb or serological reaction of syphilis.
- History of allergic or anaphylactic reaction to a therapeutic drug.
- History of recent active infections within 28 days prior to the screening visit.
- Participants with a fever within 48 hours prior to dosing.
- History of TB or active or latent or inadequately treated infection.
- Recent exposure to live vaccines within 28 days of the screening visit.
- A positive pregnancy test.
Data sourced from ClinicalTrials.gov (NCT05107492). 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.