ABOUT THE STUDY Sample Clauses

ABOUT THE STUDY. The study has up to 3 parts (Part 1, Part 2, and optional Part 3).
Sample 1
AutoNDA by SimpleDocs
ABOUT THE STUDY. Number of Study Participants There will be up to 24 participants taking part in this study. Length of Study for Participants You will be in this study for about 39 days. This does not include the time between screening and dosing, which can be up to 28 days. This study involves: • 1 dosing period • 12 overnight stays at the Clinical Research Unit (CRU). You will not be able to leave the CRU during that time • 1 follow-up phone call about 4 weeks after the last dose Eligibility to Participate in Another Drug Study Your eligibility to take part in another study depends on information from this study. You may be eligible to receive a different study drug in another study as soon as 30 days after your last dose of study drug in this study. This is true for most drugs. Some drugs may stay in your body longer which means that you may have to wait longer before joining another study. These results are usually known after your last blood sample is tested. We will tell you this as soon as possible. We will also tell you if there is a longer than usual period of time that you should not be in another drug study after this one. Our goal is to keep you from doing anything that might potentially harm you. Dosing Plan The doses of the study drugs that will be used to treat people are not yet known. The concentration of the ointment (PF-07295324) is 0.12%, and the cream (PF-07259955) is 2%. Actual dose strengths will be calculated based on your total BSA. Lower concentration doses, or doses applied to a lower BSA, or less frequent dosing may be used in participants in optional dosing groups Dosing is planned as follows: DOSING GROUP NUMBER OF PARTICIPANTS STUDY DRUG DOSE NUMBER OF APPLICATIONS PER DAY APPLICATION SITE SIZE 1 6 PF-07295324 0.12% ointment or placebo applied daily for 10 days* 2 4,000 cm2 2 6 PF-07259955 2% cream or placebo applied daily for 10 days* 2 4,000 cm2 3+ 6 PF-07295324 XXX XXX TBD
Sample 1
ABOUT THE STUDY. Number of Study Participants There will be up to 12 participants taking part in this study. Length of Study for Participants You will be in this study for about 42 days. This does not include the time between screening and dosing, which can be up to 28 days. This study involves: • 4 dosing periods during one continuous admission • 16 overnight stays at the Clinical Research Unit (CRU). You will not be able to leave the CRU during that time • 1 follow-up phone call about 4 weeks after the last dose Eligibility to Participate in Another Drug Study Your eligibility to take part in another study depends on information from this study and previous studies. You may be eligible to receive a different study drug in another study as soon as 30 days after your last dose of study drug in this study. This is true for most drugs. Some drugs may stay in your body longer which means that you may have to wait longer before joining another study. These results are usually known after your last blood sample is tested. We will tell you this as soon as possible. We will also tell you if there is a longer than usual period of time that you should not be in another drug study after this one. Our goal is to keep you from doing anything that might potentially harm you. Dosing Plan The dose of the study drug that is currently authorized to treat COVID patients is 300 mg twice a day for 5 days. Dosing in this study is planned as follows: Study Treatment A: Single oral (by mouth) dose of 300 mg of study drug (two 150 mg tablets, commercial formulation) with 100 mg of ritonavir (single 100 mg tablet) Study Treatment B: Single oral dose of 300 mg of study drug with 100 mg of ritonavir (powder formulation) mixed with water Study Treatment C: Single oral dose of 300 mg of study drug with 100 mg of ritonavir (powder formulation) mixed with applesauce Study Treatment D: Single oral dose of 300 mg of study drug with 100 mg of ritonavir (powder formulation) mixed with vanilla pudding The powder formulation that you will receive is compounded in our pharmacy for use in this study. Compounded means that the ingredients are added together and mixed to make the final dose. On Day 1 of each dosing period, you will be given a single oral dose of study drug and ritonavir after an overnight fast (nothing to eat or drink except water) of at least 10 hours. When the study drug and ritonavir are given separately, as tablets, they will be given at the same time within no more than 5 minutes of each oth...
Sample 1
ABOUT THE STUDY. Number of Study Participants There will be about 15 participants taking part in this study. Length of Study for Participants You will be in this study for about 42 days. This does not include the time between screening and dosing, which can be up to 28 days. This study involves: • 4 dosing periods during one continuous admission • 16 overnight stays at the Clinical Research Unit (CRU). You will not be able to leave the CRU during that time • 1 follow-up phone call about 4 weeks after the last dose There will be at least 4 days between each dose.
Sample 1
ABOUT THE STUDY. The study has 4 parts (Part 1, Part 2, Part 3, and Part 4). To date, the in-clinic evaluations of Part 1, Part 2 (western population) and Part 3 are completed. You will be participating in Part 4 only. This consent document is limited to describing only those procedures and dosings in Part 4 of the study that you may undergo if you qualify for and agree to participate.
Sample 1

Related to ABOUT THE STUDY

  • Conduct of the Study The Parties shall perform the Study set forth in Protocol No. [ ] dated [ ] (“Protocol”) in accordance with this Agreement, the Protocol and all applicable laws and regulations. The Institution shall follow all guidelines and instructions reasonably provided by Sponsor. [If applicable:] The Principal Investigator has, in addition to his/her Principal Investigator responsibilities, been appointed to coordinate certain activities at a national level as National Coordinating Investigator. It is the duty of the National Coordinating Investigator to obtain all approvals for the Study required pursuant to Norwegian law or regulatory requirements from the relevant Independent Ethics Committee (“IEC”) before commencing the Study. The National Coordinating Investigator shall also, to the extent required pursuant to Norwegian law or regulatory requirements, notify and obtain the consent of the relevant EC of any amendments to the Protocol. Such approvals shall be forwarded to Sponsor as they are obtained.

  • Project Monitoring by the State The State may conduct on-site or off-site monitoring reviews of the Project during the term of this Grant Agreement and for up to ninety (90) days after it expires or is otherwise terminated. The Grantee shall extend its full cooperation and give full access to the Project site and to relevant documentation to the State or its authorized designees for the purpose of determining, among other things:

  • Scope of the Services 3.1 The services that the Construction Manager shall provide include, but are not limited to those described in the following sections.

  • Phase II A small portion of the work for the Phase II modifications to the Plattsburgh Substation will be performed by Transmission Owner, and the remainder will be performed by Clinton and Xxxxxxxxx. A detailed definition of the specific scope for Transmission Owner and Clinton and Xxxxxxxxx including interface points shall be defined during the design phase and, as such documents become available, copies will be delivered to the NYISO, Transmission Owner, Noble Altona Windpark, LLC and Marble River, LLC. The full scope includes the installation of wave traps, CCVT’s and modifications and/or additions to relaying on the MWP-1 and MWP- 2 lines. These lines will be reconfigured at the completion of Phase II to connect to Xxxxx and Xxxxxxx Substations on MWP-1 and the Xxxx Substation on MWP-2. Clinton and Xxxxxxxxx will design the upgrades and purchase the materials based on the outline specification that was prepared and issued by Transmission Owner. The work to be performed by Clinton and Xxxxxxxxx will include both the materials for the exterior and interior installations and items for Transmission Owner installation inside the control building in existing relay panels and communication racks. In addition, Clinton and Xxxxxxxxx will be responsible for the exterior and interior construction work and will provide construction management services in coordination with Transmission Owner. The civil design for the foundations and the electrical design for the cable runs to the control room will be designed by, as approved by Transmission Owner, and installed under the supervision and control of Clinton and Xxxxxxxxx. The equipment will be selected and procured in accordance with the specifications developed during the detailed engineering phase, copies of which shall be furnished to the NYISO, Transmission Owner, Noble Altona Windpark, LLC and Marble River, LLC. The construction of the foundations, structures, wave traps, CCTV and cable runs into the control building to the termination cabinets will be completed by Clinton and Xxxxxxxxx. The work at the Plattsburgh Substation will be installed under Transmission Owner’s CPP-1. Transmission Owner will provide Protection and Controls Engineering, install and terminate wiring from the termination cabinets to the control panels and relays, install relays and equipment in the existing panels, and will commission such work inside the 230kV control building. Transmission Owner will develop the communications protocols and data flow over the circuits.

  • Special Studies Providing planning services, site evaluations, environmental studies, or comparative studies of prospective sites, preparing special surveys, studies, and submissions required under Applicable Law.

  • B1 The Services B1.1 The Contractor shall supply the Services during the Contract Period in accordance with the Authority’s requirements as set out in the Specification and the provisions of the Contract in consideration of the payment of the Contract Price. The Authority may inspect and examine the manner in which the Contractor supplies the Services at the Premises during normal business hours on reasonable notice.

  • Access to the Site 22.1 The Contractor shall allow the Engineer and any person authorized by the Engineer access to the Site, to any place where work in connection with the Contract is being carried out or is intended to be carried out and to any place where materials or plant are being manufactured / fabricated / assembled for the works.

  • MAINTENANCE OF THE SAID PROJECT The Promoter shall be responsible to provide and maintain essential services in the Project until the taking over of the maintenance of the project by the association of allottees upon the issuance of the completion certificate of the project. The cost of such maintenance has been included in the Total Price of the Xxxx.

  • Initiation and Processing 1. Level One

  • Performance of the Services In addition to the Common Articles, it is specified that:

Time is Money Join Law Insider Premium to draft better contracts faster.