Created at Source Raw Value Validated value
June 25, 2024, noon usa

inclusion criteria: * participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * written or thumb printed informed consent obtained from the participant prior to performance of any study specific procedure. * healthy participants as established by medical history and clinical examination before entering into the study. * a male or female between, and including, 18 and 50 years of age at the time of first study intervention administration. * body mass index\>18 kg/m\^2 and \<30 kg/m\^2. * participants with following hematological/biochemical parameters: * white blood cells within the study designated laboratory normal range. participants with fda toxicity grade 1 differential cell counts and considered not clinically significant may be enrolled at the discretion of the investigator, and with the review and approval of the medical monitor. * platelets = 125,000 - 500,000 cells/mm\^3. * hemoglobin within normal range of the study designated laboratory. * alanine aminotransferase within the study designated laboratory normal range. * aspartate aminotransferase within the study designated laboratory normal range total bilirubin within the study designated laboratory normal range. * alkaline phosphatase within the study designated laboratory normal range. * blood urea nitrogen within the study designated laboratory normal range. * serum creatinine less than or equal to 1.1 times study designated laboratory's upper limit of normal. * seronegative for hepatitis b surface antigen, hepatitis c virus antibodies, or human immunodeficiency virus antibodies. * female participants of non-childbearing potential may be enrolled in the study. non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause. * female participants of childbearing potential may be enrolled in the study, if the participant: * has practiced adequate contraception for 1 month prior to study intervention administration, and, * has a negative pregnancy test on the day of study intervention administration, and, * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study intervention administration series.

inclusion criteria: * participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * written or thumb printed informed consent obtained from the participant prior to performance of any study specific procedure. * healthy participants as established by medical history and clinical examination before entering into the study. * a male or female between, and including, 18 and 50 years of age at the time of first study intervention administration. * body mass index\>18 kg/m\^2 and \<30 kg/m\^2. * participants with following hematological/biochemical parameters: * white blood cells within the study designated laboratory normal range. participants with fda toxicity grade 1 differential cell counts and considered not clinically significant may be enrolled at the discretion of the investigator, and with the review and approval of the medical monitor. * platelets = 125,000 - 500,000 cells/mm\^3. * hemoglobin within normal range of the study designated laboratory. * alanine aminotransferase within the study designated laboratory normal range. * aspartate aminotransferase within the study designated laboratory normal range total bilirubin within the study designated laboratory normal range. * alkaline phosphatase within the study designated laboratory normal range. * blood urea nitrogen within the study designated laboratory normal range. * serum creatinine less than or equal to 1.1 times study designated laboratory's upper limit of normal. * seronegative for hepatitis b surface antigen, hepatitis c virus antibodies, or human immunodeficiency virus antibodies. * female participants of non-childbearing potential may be enrolled in the study. non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause. * female participants of childbearing potential may be enrolled in the study, if the participant: * has practiced adequate contraception for 1 month prior to study intervention administration, and, * has a negative pregnancy test on the day of study intervention administration, and, * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study intervention administration series.

June 23, 2021, 1:30 a.m. usa

inclusion criteria: - participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol. - written or thumb printed informed consent obtained from the participant prior to performance of any study specific procedure. - healthy participants as established by medical history and clinical examination before entering into the study. - a male or female between, and including, 18 and 50 years of age at the time of first study intervention administration. - body mass index>18 kg/m^2 and <30 kg/m^2. - participants with following hematological/biochemical parameters: - white blood cells within the study designated laboratory normal range. participants with fda toxicity grade 1 differential cell counts and considered not clinically significant may be enrolled at the discretion of the investigator, and with the review and approval of the medical monitor. - platelets = 125,000 - 500,000 cells/mm^3. - hemoglobin within normal range of the study designated laboratory. - alanine aminotransferase within the study designated laboratory normal range. - aspartate aminotransferase within the study designated laboratory normal range total bilirubin within the study designated laboratory normal range. - alkaline phosphatase within the study designated laboratory normal range. - blood urea nitrogen within the study designated laboratory normal range. - serum creatinine less than or equal to 1.1 times study designated laboratory's upper limit of normal. - seronegative for hepatitis b surface antigen, hepatitis c virus antibodies, or human immunodeficiency virus antibodies. - female participants of non-childbearing potential may be enrolled in the study. non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause. - female participants of childbearing potential may be enrolled in the study, if the participant: - has practiced adequate contraception for 1 month prior to study intervention administration, and, - has a negative pregnancy test on the day of study intervention administration, and, - has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study intervention administration series.

inclusion criteria: - participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol. - written or thumb printed informed consent obtained from the participant prior to performance of any study specific procedure. - healthy participants as established by medical history and clinical examination before entering into the study. - a male or female between, and including, 18 and 50 years of age at the time of first study intervention administration. - body mass index>18 kg/m^2 and <30 kg/m^2. - participants with following hematological/biochemical parameters: - white blood cells within the study designated laboratory normal range. participants with fda toxicity grade 1 differential cell counts and considered not clinically significant may be enrolled at the discretion of the investigator, and with the review and approval of the medical monitor. - platelets = 125,000 - 500,000 cells/mm^3. - hemoglobin within normal range of the study designated laboratory. - alanine aminotransferase within the study designated laboratory normal range. - aspartate aminotransferase within the study designated laboratory normal range total bilirubin within the study designated laboratory normal range. - alkaline phosphatase within the study designated laboratory normal range. - blood urea nitrogen within the study designated laboratory normal range. - serum creatinine less than or equal to 1.1 times study designated laboratory's upper limit of normal. - seronegative for hepatitis b surface antigen, hepatitis c virus antibodies, or human immunodeficiency virus antibodies. - female participants of non-childbearing potential may be enrolled in the study. non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause. - female participants of childbearing potential may be enrolled in the study, if the participant: - has practiced adequate contraception for 1 month prior to study intervention administration, and, - has a negative pregnancy test on the day of study intervention administration, and, - has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study intervention administration series.

Feb. 19, 2021, 12:31 a.m. usa

inclusion criteria: - participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol. - written or thumb printed informed consent obtained from the participant prior to performance of any study specific procedure. - healthy participants as established by medical history and clinical examination before entering into the study. - a male or female between, and including, 18 and 50 years of age at the time of first study intervention administration. - body mass index>18 kg/m^2 and <30 kg/m^2. - participants with following hematological/biochemical parameters: - white blood cells within the study designated laboratory normal range. participants with fda toxicity grade 1 differential cell counts and considered not clinically significant may be enrolled at the discretion of the investigator, and with the review and approval of the medical monitor. - platelets = 125,000 - 500,000 cells/mm^3. - hemoglobin within normal range of the study designated laboratory. - alanine aminotransferase within the study designated laboratory normal range. - aspartate aminotransferase within the study designated laboratory normal range total bilirubin within the study designated laboratory normal range. - alkaline phosphatase within the study designated laboratory normal range. - serum creatinine less than or equal to 1.1 times study designated laboratory's upper limit of normal. - seronegative for hepatitis b surface antigen, hepatitis c virus antibodies, or human immunodeficiency virus antibodies. - female participants of non-childbearing potential may be enrolled in the study. non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause. - female participants of childbearing potential may be enrolled in the study, if the participant: - has practiced adequate contraception for 1 month prior to study intervention administration, and, - has a negative pregnancy test on the day of study intervention administration, and, - has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study intervention administration series.

inclusion criteria: - participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol. - written or thumb printed informed consent obtained from the participant prior to performance of any study specific procedure. - healthy participants as established by medical history and clinical examination before entering into the study. - a male or female between, and including, 18 and 50 years of age at the time of first study intervention administration. - body mass index>18 kg/m^2 and <30 kg/m^2. - participants with following hematological/biochemical parameters: - white blood cells within the study designated laboratory normal range. participants with fda toxicity grade 1 differential cell counts and considered not clinically significant may be enrolled at the discretion of the investigator, and with the review and approval of the medical monitor. - platelets = 125,000 - 500,000 cells/mm^3. - hemoglobin within normal range of the study designated laboratory. - alanine aminotransferase within the study designated laboratory normal range. - aspartate aminotransferase within the study designated laboratory normal range total bilirubin within the study designated laboratory normal range. - alkaline phosphatase within the study designated laboratory normal range. - serum creatinine less than or equal to 1.1 times study designated laboratory's upper limit of normal. - seronegative for hepatitis b surface antigen, hepatitis c virus antibodies, or human immunodeficiency virus antibodies. - female participants of non-childbearing potential may be enrolled in the study. non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause. - female participants of childbearing potential may be enrolled in the study, if the participant: - has practiced adequate contraception for 1 month prior to study intervention administration, and, - has a negative pregnancy test on the day of study intervention administration, and, - has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study intervention administration series.