Phase 1
N=18
A Study to Learn About The Study Medicine (Called PF-06823859) in Healthy Chinese Participants
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT05257798 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Maximum Serum Concentration(Cmax) for PF-06823859 — 307.4 micrograms/milliliter (ug/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- IFN-β inhibitor treatment (Drug); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Serum Concentration(Cmax) for PF-06823859 |
307.4 | — |
| PRIMARY Time at Which Cmax Occured (Tmax) for PF-06823859 in Serum |
1.52 | — |
| PRIMARY Area Under the Concentration-time Profile From Time Zero to 14 Days (336 Hours) Post-dose (AUC14day) for PF-06823859 in Serum |
48550 | — |
| PRIMARY Area Under the Concentration-time Profile From Time Zero to 28 Days (672 Hours) Post-dose (AUC28day) for PF-06823859 in Serum |
73240 | — |
| PRIMARY Area Under the Serum Concentration-time Profile From Time Zero Extrapolated to Infinite Time(AUCinf) for PF-06823859 in Serum. |
127100 | — |
| PRIMARY Terminal Half-life (t1/2) for PF-06823859 in Serum. |
26.96 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
14; 2; 0; 0 | — |
| PRIMARY Number of Participants With Pre-Specified Categorization for Vital Signs (Diastolic Blood Pressure) |
1; 0 | — |
| PRIMARY Number of Participants With Pre-Specified Categorization for Vital Signs (Systolic Blood Pressure) |
1; 0; 1; 0 | — |
| PRIMARY Number of Participants With Pre-Specified Categorization (Maximum Change From Baseline) for ECG Data |
0; 0 | — |
| PRIMARY Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). |
1; 0; 1; 0; 1; 0 | — |
| PRIMARY Number of Participants With Viral Infections |
3; 0 | — |
| SECONDARY Area Under the Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (Clast) (AUClast) for PF-06823859 in Serum |
124700 | — |
| SECONDARY Clearance(CL) for PF-06823859 in Serum |
0.007084 | — |
| SECONDARY Volume of Distribution at Steady State (Vss) for PF-06823859 in Serum |
5.800 | — |
| SECONDARY Mean Residence Time (MRT) for PF-06823859 in Serum |
34.13 | — |
| SECONDARY Number of Participants With Positive Anti-drug Antibody (ADA) of PF-06823859 |
— | — |
Summary
The purpose of this clinical trial is to learn if the study medicine (called PF-06823859) is safe and how it is processed in healthy Chinese participants. This study is seeking participants who:
* Are between 18 to 45 years of age, inclusive, at the time of signing the Informed Consent Document (ICD).
* Are Chinese participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12 lead ECG (electrocardiogram).
* Have a BMI (body mass index) of 19 to 27 kg/m2 (inclusive); and a total body weight >50 kg (110 lb).
All participants in this study will receive PF-06823859 or a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. PF-06823859 will be given as an infusion directly into a vein. We will compare the experiences of people receiving PF-06823859 to those of people who do not. This will help us determine if PF-06823859 is safe and how it behaves inside the human body.
Participants will take part in this study for up to 157 days. During this time, they will receive PF-06823859 or placebo and be observed for any effects.
Eligibility Criteria
1.1. Inclusion Criteria
- Male and female participants must be 18 to 45 years of age, inclusive, at the time of signing the ICD (informed consent document).
- Male and female Chinese participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12 lead ECG (electrocardiogram).
- BMI (body mass index) of 19 to 27 kg/m2 (inclusive); and a total body weight >50 kg (110 lb).
1.2. Exclusion Criteria
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
- History of HIV (human immunodeficiency virus) infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg (hepatitis B surface antigen), or HCVAb (hepatitis C antibody).
- History of autoimmune disorders.
- 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 7 days prior to dosing.
- Infected with Mycobacterium TB (tuberculosis)
- Contact with positive case of COVID (coronavirus disease)-19 or travel to an area defined as high risk by relevant authority in the past 14 days.
- 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.
- Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
- Current use of any prohibited concomitant medication(s) or those unwilling/unable to use a permitted concomitant medication(s).
Data sourced from ClinicalTrials.gov (NCT05257798). 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.