Length of Study for Participants. You will be in this study for about 44 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 dosing period during 1 continuous admission • 18 overnight stays at the CRU. You will not be able to leave the CRU during that time • 1 follow-up visit about 7 days after the last dose • 1 follow-up phone call about 4 weeks after the last dose
Length of Study for Participants. If you are in Group 1 or 2, you will be in this study for about 64 days. If you are in the Japanese dosing group (if done), you will be in this study for about 37 days. If you are in Group 4, you will be in this study for about 51 days. This does not include the time between screening and dosing, which can be up to 28 days. This part of the study involves: • Dosing groups 1 and 2 have 4 dosing periods with 2 separate admissions. Each admission has up to 11 overnight stays at the Clinical Research Unit (CRU). You will not be able to leave the CRU during the 2 admission periods o A Japanese dosing group, if done, will have 2 dosing periods during 1 continuous admission with 11 overnight stays o Dosing group 4 has 4 dosing periods during 1 continuous admission with up to 25 overnight stays • 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 There will be about 7 days between each dose. However this may be changed based on emerging data.
Length of Study for Participants. If you are in Groups 1 or 2, you will be in this study for about 271 days. If you are in Groups 3 through 8, or group 12 (optional, may not be done), you will be in this study for about 541 days. The length of study does not include the time between screening and dosing, which can be up to 28 days. Additional follow-up visits, at up to 3-month intervals, up to a maximum of 12 months, after the last planned follow-up visit, may be needed depending on the study results. The number of follow-up visits/duration of study participation may be decreased depending on the study data from earlier groups. This study involves: • 1 dosing period • 5 overnight stays at the Clinical Research Unit (CRU). You will not be able to leave the CRU during that time • 8 planned follow-up visits Groups 3 – 8, and 12 (if done) • 1 dosing period • 5 overnight stays at the CRU. You will not be able to leave the CRU during that time • 11 planned follow-up visits 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 you are discharged from the study. If the study drug stays in your body longer, or you are having an immune response, you may need to wait as long as 6 to 8 months, or longer, before you can screen for another study. These results are usually known after your last regularly scheduled 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 will be used to treat people is not yet known. Up to 9 groups of participants are planned for this part of the study. Dosing in Part A of the study is planned as follows: GROUP NUMBER NUMBER OF PARTICIPANTS STUDY DAY 1
Length of Study for Participants. Dosing Sequence 1 You will be in this study for about 49 days. This does not include the time between screening and dosing, which can be up to 28 days. This part of the study involves: • 3 dosing periods during 1 continuous admission. • 23 overnight stays at the 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 There will be at least 10 days between dosing in Period 1 and Period 2, and at least 7 days between dosing in Period 2 and Period 3. Dosing Sequence 2 You will be in this study for about 44 days. This does not include the time between screening and dosing, which can be up to 28 days. This part of the study involves: • 3 dosing periods during 1 continuous admission • 18 overnight stays at the 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 There will be at least 7 days between each dose.
