Who may participate

enhanced studyBy volunteering in clinical research, you can make a difference for people diagnosed with sickle cell disease. Thank you for exploring whether participation in this study may interest you.

This study is seeking healthy male or female volunteers, meaning that the participants will not have the condition being studied. In addition to the criteria listed, participants must meet the following requirements:

  • Females must be unable to bear children (either surgically sterile or post-menopausal)
  • Willing to take a study drug
  • Able to meet all study visit requirements

There are other requirements for participation in this study. The study staff will explain these to you during the screening process.

Condition
Healthy
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Age
18-55 years
The age a person must be to participate in a clinical trial.
Sex
Male or Female
The sex of people who may participate in a clinical trial. Sex is a person's classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.

What to expect

enhanced studyIf this study may be a fit for you, you’ll be invited to a screening visit at our facility in New Haven, CT. If you qualify for the study, there may be a period of up to 28 days before dosing begins.

You will be placed into either Part 1 or Part 2 of this study.

Part 1 involves:

  • 11 consecutive overnight stays
  • 1 dose of the study drug given by subcutaneous (under the skin) injection or intravenous (IV) infusion
  • Follow-up visits and calls up to 121 days (~4 months) after dose

Part 2 involves:

  • 17 overnight stays over 25 days
  • 3 doses of the study drug given by subcutaneous injection, 7 days apart
  • Follow-up visits and calls up to 149 days (~5 months) after last dose

This study is the first time the study drug will be given to people. In both parts, staff will monitor your health status and collect data such as the levels of the study drug in your blood.

Required overnight stays
Part 1: 11 overnight stays — Part 2: 17 overnight stays
A participant may be required to stay overnight at the PCRU for observation and study procedures. The number and length of overnight stays is determined by the design of the study.
Long-term follow up
Part 1: 4 follow-up visits & 1 call — Part 2: 3 follow-up visits & 2 calls
Some studies require the study team to stay in contact with the participant for a period of time after the participant completes the main part of the study. This long-term follow up is to collect additional information on the study drug over time.
How long is this study?
Part 1: up to 121 days — Part 2: up to 149 days
This does not include the period between screening and when dosing begins, which can be up to 28 days. The study lasts up to 121 days (Part 1) or 149 days (Part 2) from the first dose through the last follow-up call or visit.
Compensation
Part 1: Up to $6,225 — Part 2: Up to $8,225 upon completion of the study
Participants in clinical trials at the PCRU receive financial compensation for their participation. The amount depends on factors like length of the stay, total number of study visits, and the nature of the study procedures.

Interested in participating?

Complete and submit this form, and a Pfizer Clinical Research Unit (PCRU) representative will contact you.

You may also call 1-800-254-6398 and speak with a PCRU representative to learn more.

The personal data gathered here will be collected, processed, and maintained in a confidential manner. Your information will be stored in our research units database. We may use this information to invite you to participate in this clinical study, as well as other current and future clinical studies at the PCRU. You will have full access to your records at the Pfizer New Haven Clinical Research Unit and the opportunity to correct them if necessary.

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