Clinical trial NCT05257798: A Study to Learn About The Study Medicine (Called PF-06823859) in Healthy Chinese Participants
Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY OPEN, PLACEBO CONTROLLED, STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY FOLLOWING A SINGLE DOSE OF PF-06823859 IN HEALTHY CHINESE PARTICIPANTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-02-25
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: This is a Phase 1, randomized, double blind, sponsor open, placebo controlled study to evaluate the PK, safety, and tolerability following a single dose of PF 06823859 (900 mg) in healthy Chinese participants.

Eligibility criteria: 1.1. Inclusion Criteria

1. Male and female participants must be 18 to 45 years of age, inclusive, at the time of signing the ICD (informed consent document).
2. 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).
3. BMI (body mass index) of 19 to 27 kg/m2 (inclusive); and a total body weight \>50 kg (110 lb).

1.2. Exclusion Criteria

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
2. 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).
3. History of autoimmune disorders.
4. History of allergic or anaphylactic reaction to a therapeutic drug.
5. History of recent active infections within 28 days prior to the screening visit.
6. Participants with a fever within 7 days prior to dosing.
7. Infected with Mycobacterium TB (tuberculosis)
8. 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.
9. 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.
10. 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.
11. Current use of any prohibited concomitant medication(s) or those unwilling/unable to use a permitted concomitant medication(s).

Primary outcomes:
measure: Maximum Serum Concentration(Cmax) for PF-06823859
timeFrame: Days 1 (pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.
measure: Time at Which Cmax Occured (Tmax) for PF-06823859 in Serum
timeFrame: Days 1 (pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.
measure: Area Under the Concentration-time Profile From Time Zero to 14 Days (336 Hours) Post-dose (AUC14day) for PF-06823859 in Serum
timeFrame: Days 1 (pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.
measure: Area Under the Concentration-time Profile From Time Zero to 28 Days (672 Hours) Post-dose (AUC28day) for PF-06823859 in Serum
timeFrame: Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.
measure: Area Under the Serum Concentration-time Profile From Time Zero Extrapolated to Infinite Time(AUCinf) for PF-06823859 in Serum.
timeFrame: Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.
measure: Terminal Half-life (t1/2) for PF-06823859 in Serum.
timeFrame: Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From first dose of study drug/Day 1 to Day 157
measure: Number of Participants With Pre-Specified Categorization for Vital Signs (Diastolic Blood Pressure)
timeFrame: Days 1 (pre-dose),5,29,57,100,127 and 157.
measure: Number of Participants With Pre-Specified Categorization for Vital Signs (Systolic Blood Pressure)
timeFrame: Days 1 (pre-dose),5,29,57,100,127 and 157.
measure: Number of Participants With Pre-Specified Categorization (Maximum Change From Baseline) for ECG Data
timeFrame: Days -1, 5,29,57,100,127 and 157.
measure: Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality).
timeFrame: Days -1, 2, 5,8,15,29,57,100,127 and 157.
measure: Number of Participants With Viral Infections
timeFrame: From Screening up to Day157
Secondary outcomes:
measure: Area Under the Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (Clast) (AUClast) for PF-06823859 in Serum
timeFrame: Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.
measure: Clearance(CL) for PF-06823859 in Serum
timeFrame: Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.
measure: Volume of Distribution at Steady State (Vss) for PF-06823859 in Serum
timeFrame: Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.
measure: Mean Residence Time (MRT) for PF-06823859 in Serum
timeFrame: Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.
measure: Number of Participants With Positive Anti-drug Antibody (ADA) of PF-06823859
timeFrame: Days 1 (pre-dose), 15,29, 57, 71, 100, 127 and 157.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: