inclusion criteria: 1. participant must be ≥ 18 years of age at the time of signing the informed consent. 2. medically stable such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain in follow-up through the end of protocol-specified follow-up. * a stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months prior to enrolment 3. able to understand and comply with study requirements/procedures based on the assessment of the investigator. 4. male and/or female 5. female participants 1. women of childbearing potential must: * have a negative pregnancy test on the day of screening and on day 1 * use one highly effective form of birth control for at least 28 days prior to day 1 and agree to continue using one highly effective form of birth control through 60 days following administration of the second dose of study intervention. a highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. periodic abstinence, the rhythm method, and withdrawal are not acceptable methods of contraception. 2. women are considered of childbearing potential unless they meet either of the following criteria: * surgically sterilised (including bilateral tubal ligation, bilateral ophorectomy, or hysterectomy), or * postmenopausal * for women aged \< 50 years, postmenopausal is defined as having both: * a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment, and * a follicle-stimulating hormone level in the post-menopausal range until follicle-stimulating hormone is documented to be within menopausal range, the participant is to be considered of childbearing potential * for women aged ≥ 50 years, postmenopausal is defined as having a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment 6. capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the icf and in the protocol

inclusion criteria: 1. participant must be ≥ 18 years of age at the time of signing the informed consent. 2. medically stable such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain in follow-up through the end of protocol-specified follow-up. * a stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months prior to enrolment 3. able to understand and comply with study requirements/procedures based on the assessment of the investigator. 4. male and/or female 5. female participants 1. women of childbearing potential must: * have a negative pregnancy test on the day of screening and on day 1 * use one highly effective form of birth control for at least 28 days prior to day 1 and agree to continue using one highly effective form of birth control through 60 days following administration of the second dose of study intervention. a highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. periodic abstinence, the rhythm method, and withdrawal are not acceptable methods of contraception. 2. women are considered of childbearing potential unless they meet either of the following criteria: * surgically sterilised (including bilateral tubal ligation, bilateral ophorectomy, or hysterectomy), or * postmenopausal * for women aged \< 50 years, postmenopausal is defined as having both: * a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment, and * a follicle-stimulating hormone level in the post-menopausal range until follicle-stimulating hormone is documented to be within menopausal range, the participant is to be considered of childbearing potential * for women aged ≥ 50 years, postmenopausal is defined as having a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment 6. capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the icf and in the protocol

inclusion criteria: participant must be ≥ 18 years of age at the time of signing the informed consent. medically stable such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain in follow-up through the end of protocol-specified follow-up. a stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months prior to enrolment able to understand and comply with study requirements/procedures based on the assessment of the investigator. male and/or female female participants women of childbearing potential must: have a negative pregnancy test on the day of screening and on day 1 use one highly effective form of birth control for at least 28 days prior to day 1 and agree to continue using one highly effective form of birth control through 60 days following administration of the second dose of study intervention. a highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. periodic abstinence, the rhythm method, and withdrawal are not acceptable methods of contraception. women are considered of childbearing potential unless they meet either of the following criteria: surgically sterilised (including bilateral tubal ligation, bilateral ophorectomy, or hysterectomy), or postmenopausal for women aged < 50 years, postmenopausal is defined as having both: a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment, and a follicle-stimulating hormone level in the post-menopausal range until follicle-stimulating hormone is documented to be within menopausal range, the participant is to be considered of childbearing potential for women aged ≥ 50 years, postmenopausal is defined as having a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the icf and in the protocol

inclusion criteria: participant must be ≥ 18 years of age at the time of signing the informed consent. medically stable such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain in follow-up through the end of protocol-specified follow-up. a stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months prior to enrolment able to understand and comply with study requirements/procedures based on the assessment of the investigator. male and/or female female participants women of childbearing potential must: have a negative pregnancy test on the day of screening and on day 1 use one highly effective form of birth control for at least 28 days prior to day 1 and agree to continue using one highly effective form of birth control through 60 days following administration of the second dose of study intervention. a highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. periodic abstinence, the rhythm method, and withdrawal are not acceptable methods of contraception. women are considered of childbearing potential unless they meet either of the following criteria: surgically sterilised (including bilateral tubal ligation, bilateral ophorectomy, or hysterectomy), or postmenopausal for women aged < 50 years, postmenopausal is defined as having both: a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment, and a follicle-stimulating hormone level in the post-menopausal range until follicle-stimulating hormone is documented to be within menopausal range, the participant is to be considered of childbearing potential for women aged ≥ 50 years, postmenopausal is defined as having a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the icf and in the protocol

inclusion criteria: 1. participant must be ≥ 18 years of age at the time of signing the informed consent. 2. medically stable such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain in follow-up through the end of protocol-specified follow-up. - a stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months prior to enrolment 3. able to understand and comply with study requirements/procedures based on the assessment of the investigator. 4. male and/or female 5. female participants 1. women of childbearing potential must: - have a negative pregnancy test on the day of screening and on day 1 - use one highly effective form of birth control for at least 28 days prior to day 1 and agree to continue using one highly effective form of birth control through 60 days following administration of the second dose of study intervention. a highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. periodic abstinence, the rhythm method, and withdrawal are not acceptable methods of contraception. 2. women are considered of childbearing potential unless they meet either of the following criteria: - surgically sterilised (including bilateral tubal ligation, bilateral ophorectomy, or hysterectomy), or - postmenopausal - for women aged < 50 years, postmenopausal is defined as having both: - a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment, and - a follicle-stimulating hormone level in the post-menopausal range until follicle-stimulating hormone is documented to be within menopausal range, the participant is to be considered of childbearing potential - for women aged ≥ 50 years, postmenopausal is defined as having a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment 6. capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the icf and in the protocol

inclusion criteria: 1. participant must be ≥ 18 years of age at the time of signing the informed consent. 2. medically stable such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain in follow-up through the end of protocol-specified follow-up. - a stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months prior to enrolment 3. able to understand and comply with study requirements/procedures based on the assessment of the investigator. 4. male and/or female 5. female participants 1. women of childbearing potential must: - have a negative pregnancy test on the day of screening and on day 1 - use one highly effective form of birth control for at least 28 days prior to day 1 and agree to continue using one highly effective form of birth control through 60 days following administration of the second dose of study intervention. a highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. periodic abstinence, the rhythm method, and withdrawal are not acceptable methods of contraception. 2. women are considered of childbearing potential unless they meet either of the following criteria: - surgically sterilised (including bilateral tubal ligation, bilateral ophorectomy, or hysterectomy), or - postmenopausal - for women aged < 50 years, postmenopausal is defined as having both: - a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment, and - a follicle-stimulating hormone level in the post-menopausal range until follicle-stimulating hormone is documented to be within menopausal range, the participant is to be considered of childbearing potential - for women aged ≥ 50 years, postmenopausal is defined as having a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment 6. capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the icf and in the protocol