HEALTHY VOLUNTEERS NEEDED-C4071001

Study Graphic

 

 

You may be eligible if:

  • You are a healthy male or female (unable to bear children) 18-55 years of age.
  • You are able to meet all eligibility criteria
  • You are able to comply with all study visits.

Study Number: C4071001

Be compensated for your time: Part 1– $6,225.00 ($4,960.00 plus $1,265.00 completion bonus) Part 2– $8,225.00 ($6,580.00 plus $1,645.00 completion bonus)

The Pfizer New Haven Clinical Research Unit is conducting a study of new investigational drug being studied to treat people with sickle cell disease (SCD). An “investigational drug” is a drug that has no been approved to treat disease. SCD is an anemia that occurs mostly in Africans and people of African descent. This research study will be the first time that single and multiple doses of the study drug will be given to people.

This study involves:

You will be in this study up to about 121 days if you are in Part 1 of the study or up to 149 days if you are in Part 2 of the study. This does not include the time between screening and dosing, which can be up to 28 days.

Part 1

  • 1 dosing period
  • 11 overnight stays
  • 1 follow-up phone call
  • 4 follow-up visits

Part 2

  • 1 dosing period (one SC injection a week for 3 weeks, 3 separate admissions)
  • 17 overnight stays
  • 2 follow-up phone calls
  • 3 follow-up visits

Part 1 and 2

There is a chance that an additional follow-up visit may be needed about 3 months after the last scheduled follow-up visits. This will be done if any participate in your group has developed an anti-drug antibody (ADA) or neutralizing antibody (Nab) to the study drug (measurements of the body’s immune response to a drug).

Please review the informed consent document: C4071001 ICD 27Feb2020