Dose Escalation Study of PF-07209326 in Healthy Participants

NCT04255875

Last updated date
Study Location
New Haven Clinical Research Unit
New Haven, Connecticut, 06511, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, immunocompromised (or known disorder of the immune
system), cardiovascular, hepatic, psychiatric, neurological, or allergic disease
(including drug allergies, but excluding untreated, asymptomatic, seasonal allergies
at the time of dosing).


2. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C;
positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core
antibody (HBcAb), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.


3. History of active or latent tuberculosis (TB) regardless of treatment or positive
QuantiFeron TB test.


4. Participants with any of the following acute or chronic infections or infection
history:


- Any infection requiring treatment within 2 weeks prior to the screening visit.


- Any infection requiring hospitalization, parenteral antimicrobial therapy within
30 days of the first dose of investigational product.


- Any infection judged to be an opportunistic infection, within the past 6 months
of the first dose of the investigational product.


- Known active or history of frequent bacterial, viral, fungal, mycobacterial or
other infections as determined by the PI.


- Participants with a fever within the last 7 days prior to dosing.


5. Participants with a history of allergic or anaphylactic reaction to therapeutic or
diagnostic protein.


6. Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the participant inappropriate for entry into
this study.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Advanced Information
Descriptive Information
Brief Title  ICMJE Dose Escalation Study of PF-07209326 in Healthy Participants
Official Title  ICMJE A RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF-07209326 IN HEALTHY PARTICIPANTS
Brief Summary This Phase 1 first-in-human single ascending dose and multiple dose study will be a randomized, double-blind, placebo-controlled investigation of the safety, tolerability, and pharmacokinetics of PF-07209326.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: Placebo
    Participants will receive matching placebo
  • Biological: PF-07209326
    Participants will receive SC or IV single ascending doses
Study Arms  ICMJE
  • Experimental: Treatment
    Participants will receive single ascending doses of subcutaneous (SC) or intravenous PF-07209326
    Intervention: Biological: PF-07209326
  • Placebo Comparator: Placebo
    Participants will receive matching placebo
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 3, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 11, 2021
Estimated Primary Completion Date March 11, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, immunocompromised (or known disorder of the immune system), cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  2. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
  3. History of active or latent tuberculosis (TB) regardless of treatment or positive QuantiFeron TB test.
  4. Participants with any of the following acute or chronic infections or infection history:

    • Any infection requiring treatment within 2 weeks prior to the screening visit.
    • Any infection requiring hospitalization, parenteral antimicrobial therapy within 30 days of the first dose of investigational product.
    • Any infection judged to be an opportunistic infection, within the past 6 months of the first dose of the investigational product.
    • Known active or history of frequent bacterial, viral, fungal, mycobacterial or other infections as determined by the PI.
    • Participants with a fever within the last 7 days prior to dosing.
  5. Participants with a history of allergic or anaphylactic reaction to therapeutic or diagnostic protein.
  6. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04255875
Other Study ID Numbers  ICMJE C4071001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP