Number of Study Participants Sample Clauses

Number of Study Participants. There will be about 18 people joining this part of the study. You will be in this study for about 77 days. This does not include the time between screening and dosing, which can be up to 28 days. This part of the study involves: • 1 outpatient run-in period (4 weeks) with 4 outpatient visits to the Clinical Research Unit (CRU) • 1 dosing period during 1 continuous admission. 23 overnight stays at CRU. You will not be able to leave the CRU during that time • 1 follow-up visit to the CRU about 7 days after the last dose • 1 follow-up phone call about 4 weeks after the last dose 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. The dose of the study drug that will be used to treat people is not yet known. The dose of study drug in this part of the study will be determined based on information from the previous dosing groups. Dosing is planned as follows: DOSING GROUP NUMBER OF PARTICIPANTS STUDY DAYS -35 to -29 -28 to -22 -21 to -15 -14 to -8 -7 to -1 1 to 14 1 18 0.6 mg Saxenda 1.2 mg Saxenda 1.8 mg Saxenda 2.4 mg Saxenda 3 mg Saxenda 3 mg Saxenda + TBD* mg study drug or placebo *TBD – to be determined. Dosing for this part of the study will be based on data from the earlier dosing groups. It will be randomly assigned, like the flip of a coin, who receives either study drug or placebo You have about a 1 in 3 chance of being on placebo during the study. On study Day -35, you will visit the CRU for your first injection of Saxenda. It will be given to you by a qualified member of the study staff. Saxenda is given in the abdomen, upper thighs, or upper arms. You will be instructed on how to self-administer Saxenda at home during the 4 week run-in period. You will be given sufficient supplies for dosing at home and instructions about food and beverages relative to the timing of your once daily injections. You will also be instructed...
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Number of Study Participants. There will be up to about 24 people taking part in this study. You will be in this study for up to about 58 days if you are in Cohort (group) 1, 51 days if you are in Cohort 2 (if done), and 44 days if you are in Cohort 3 (participants of Japanese descent, if done). This does not include the time between screening and dosing, which can be up to 28 days. This study involves: • Up to 5 dosing periods with separate admissions for each period o There will be at least 7 days between each dose • Each admission has 4 overnight stays at the Clinical Research Unit (CRU). You will not be able to leave the CRU during that time • 1 follow-up visit about 1 week after the last dose • 1 follow-up phone call about 4 weeks after the last dose Cohort 2 • Up to 4 dosing periods with separate admissions for each period o There will be at least 7 days between each dose • Each admission has 4 overnight stays at the CRU. You will not be able to leave the CRU during that time • 1 follow-up visit about 1 week after the last dose • 1 follow-up phone call about 4 weeks after the last dose Cohort 3 • Up to 3 dosing periods during 1 continuous admission o There will be at least 7 days between each dose • 18 overnight stays at the CRU. You will not be able to leave the CRU during that time • 1 follow-up visit about 1 week after the last dose • 1 follow-up phone call about 4 weeks after the last dose 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 early 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. The dose of the study drug used to treat people is not yet known. Up to 3 cohorts of participants are planned. Dosing is planned as follows: Cohort 2 (optional)
Number of Study Participants. [NUMBER OF PARTICIPANTS] Description Frequency/details Per Unit Total for all participants
Number of Study Participants. There will be about 42 people taking part in this study. You will be in this study for up to about 50 days. This does not include the time between screening and dosing, which can be up to 28 days. This study involves: • 3 dosing periods during 1 continuous admission • 22 overnight stays at the 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 7 days between the last dose in one period and the first dose in the next period Your eligibility to take part in another study depends on information from the previous study and this study. You may be eligible to receive a different study drug in another study as early 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. The dose of the study drug that will be used to treat people is not yet known. One group of 42 participants is planned. Dosing is planned as follows:
Number of Study Participants. There will be about 14 people taking part in this study. If possible, 4 of the people will be of Japanese descent. The safety of the study drug and the amount of the study drug in the blood in Japanese participants, if enrolled, will be compared to that of non-Japanese participants. You will be in this study for up to about 29 days. This does not include the time between screening and dosing, which can be up to 28 days. This study involves: • 2 dosing periods with a single admission. The admission has 3 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 Your eligibility to take part in another study depends on information from previous studies. You may be eligible to receive a different study drug in another study as early 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. The recommended dose of the study drug used to treat people is 10 mg. One group of 14 participants is planned. Participants will be split into two groups of 7 each. Dosing is planned as follows: STUDY GROUP NUMBER OF PARTICIPANTS STUDY PERIOD 1 2
Number of Study Participants. This study is being done at about 2 different study sites in 2 countries. There will be up to 60 people in the study, 12 participants in Part 1, up to 30 participants in Part 2 (including 6 Japanese participants if the optional Japanese group is conducted) and a maximum of 18 participants in Part 3 (if done).
Number of Study Participants. This study is being done at about 2 different study sites in 2 countries. There will be up to 12 participants in this part of the study. You will be in this study for up to about 51 days. This does not include the time between screening and dosing, which can be up to 28 days. This study involves:  Up to 4 dosing periods (Periods 3 and 4 are optional) during a continuous admission  Up to 20 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 of study drug 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. The dose of the study drug that will be used to treat COVID patients is not yet known. One group of up to 12 participants will be in this part of the study. The total daily dose level of study drug in this cohort will not exceed 3,000 mg. Dosing is planned as follows: Dosing Sequence Number of Participants Dosing Periods
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Number of Study Participants. There will be about 53 participants taking part in this part of the study. This study is being done at about 4 different study sites in 2 countries. It is expected that about 11 people will take part in this part of the study at this location. This research study may use competitive enrollment. This means that when a certain number of people have entered the research study from all research sites combined, no one else will be allowed to participate. It is possible that you may not be allowed to join the research study.

Related to Number of Study Participants

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