inclusion criteria: healthy males and females between 18 to 55 years of age, inclusive, at the screening visit. subject voluntarily agrees to participate in this study and signs an ethics committee approved informed consent prior to performing any of the screening visit procedures. subject is able to understand and is willing to comply with all study requirements, and willing to follow the instructions of the study staff. women of childbearing potential must have a negative pregnancy test, should not be breastfeeding, and must be willing to use highly effective methods of contraception for at least 1 month before, while participating in this study and until 1 month after the end of the treatment. the following terms of contraception apply: 4.1. total abstinence (when this is in line with the preferred and usual lifestyle of the participant). periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 4.2. female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study intervention. in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment. 4.3. sterilization of male partner (at least 6 months prior to screening) with post-procedural semen specimen to verify a successful procedure (the report of the male partner will not be collected since the partner is not study participant). for female participants on the study, the vasectomized male partner should be the sole partner for that participant. 4.4. placement of an intrauterine device or intrauterine system, or other forms of non-hormonal contraception that have comparable efficacy (failure rate <1%). 4.5. women who are postmenopausal are not required to use contraception. a postmenopausal state is defined as no menses for 12 months without an alternative medical cause. a high follicle stimulating hormone (fsh) level in the postmenopausal range (fsh > 40 u/ml at screening) must be used to confirm a postmenopausal state. male subject must agree to stay abstinent or must use together with his female partner(s) use a form of highly effective contraceptive from the time of signing the informed consent form (icf) until up to 3 months after receiving the study drug. nonsmokers (and/or no use of other nicotine products during 1 year before screening visit). body mass index (bmi) between 18.0 and 32.0 kg/m2, inclusive, at the screening visit. healthy with no clinically significant findings, determined by medical evaluation (medical history, physical examination, vital signs, 12-lead ecg, and clinical laboratory evaluations) at screening. forced expiratory volume in 1 second (fev1) ≥80%.

inclusion criteria: healthy males and females between 18 to 55 years of age, inclusive, at the screening visit. subject voluntarily agrees to participate in this study and signs an ethics committee approved informed consent prior to performing any of the screening visit procedures. subject is able to understand and is willing to comply with all study requirements, and willing to follow the instructions of the study staff. women of childbearing potential must have a negative pregnancy test, should not be breastfeeding, and must be willing to use highly effective methods of contraception for at least 1 month before, while participating in this study and until 1 month after the end of the treatment. the following terms of contraception apply: 4.1. total abstinence (when this is in line with the preferred and usual lifestyle of the participant). periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 4.2. female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study intervention. in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment. 4.3. sterilization of male partner (at least 6 months prior to screening) with post-procedural semen specimen to verify a successful procedure (the report of the male partner will not be collected since the partner is not study participant). for female participants on the study, the vasectomized male partner should be the sole partner for that participant. 4.4. placement of an intrauterine device or intrauterine system, or other forms of non-hormonal contraception that have comparable efficacy (failure rate <1%). 4.5. women who are postmenopausal are not required to use contraception. a postmenopausal state is defined as no menses for 12 months without an alternative medical cause. a high follicle stimulating hormone (fsh) level in the postmenopausal range (fsh > 40 u/ml at screening) must be used to confirm a postmenopausal state. male subject must agree to stay abstinent or must use together with his female partner(s) use a form of highly effective contraceptive from the time of signing the informed consent form (icf) until up to 3 months after receiving the study drug. nonsmokers (and/or no use of other nicotine products during 1 year before screening visit). body mass index (bmi) between 18.0 and 32.0 kg/m2, inclusive, at the screening visit. healthy with no clinically significant findings, determined by medical evaluation (medical history, physical examination, vital signs, 12-lead ecg, and clinical laboratory evaluations) at screening. forced expiratory volume in 1 second (fev1) ≥80%.

inclusion criteria: 1. healthy males and females between 18 to 55 years of age, inclusive, at the screening visit. 2. subject voluntarily agrees to participate in this study and signs an ethics committee approved informed consent prior to performing any of the screening visit procedures. 3. subject is able to understand and is willing to comply with all study requirements, and willing to follow the instructions of the study staff. 4. women of childbearing potential must have a negative pregnancy test, should not be breastfeeding, and must be willing to use highly effective methods of contraception for at least 1 month before, while participating in this study and until 1 month after the end of the treatment. the following terms of contraception apply: 4.1. total abstinence (when this is in line with the preferred and usual lifestyle of the participant). periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 4.2. female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study intervention. in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment. 4.3. sterilization of male partner (at least 6 months prior to screening) with post-procedural semen specimen to verify a successful procedure (the report of the male partner will not be collected since the partner is not study participant). for female participants on the study, the vasectomized male partner should be the sole partner for that participant. 4.4. placement of an intrauterine device or intrauterine system, or other forms of non-hormonal contraception that have comparable efficacy (failure rate <1%). 4.5. women who are postmenopausal are not required to use contraception. a postmenopausal state is defined as no menses for 12 months without an alternative medical cause. a high follicle stimulating hormone (fsh) level in the postmenopausal range (fsh > 40 u/ml at screening) must be used to confirm a postmenopausal state. 5. male subject must agree to stay abstinent or must use together with his female partner(s) use a form of highly effective contraceptive from the time of signing the informed consent form (icf) until up to 3 months after receiving the study drug. 6. nonsmokers (and/or no use of other nicotine products during 1 year before screening visit). 7. body mass index (bmi) between 18.0 and 32.0 kg/m2, inclusive, at the screening visit. 8. healthy with no clinically significant findings, determined by medical evaluation (medical history, physical examination, vital signs, 12-lead ecg, and clinical laboratory evaluations) at screening. 9. forced expiratory volume in 1 second (fev1) ≥80%.

inclusion criteria: 1. healthy males and females between 18 to 55 years of age, inclusive, at the screening visit. 2. subject voluntarily agrees to participate in this study and signs an ethics committee approved informed consent prior to performing any of the screening visit procedures. 3. subject is able to understand and is willing to comply with all study requirements, and willing to follow the instructions of the study staff. 4. women of childbearing potential must have a negative pregnancy test, should not be breastfeeding, and must be willing to use highly effective methods of contraception for at least 1 month before, while participating in this study and until 1 month after the end of the treatment. the following terms of contraception apply: 4.1. total abstinence (when this is in line with the preferred and usual lifestyle of the participant). periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 4.2. female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study intervention. in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment. 4.3. sterilization of male partner (at least 6 months prior to screening) with post-procedural semen specimen to verify a successful procedure (the report of the male partner will not be collected since the partner is not study participant). for female participants on the study, the vasectomized male partner should be the sole partner for that participant. 4.4. placement of an intrauterine device or intrauterine system, or other forms of non-hormonal contraception that have comparable efficacy (failure rate <1%). 4.5. women who are postmenopausal are not required to use contraception. a postmenopausal state is defined as no menses for 12 months without an alternative medical cause. a high follicle stimulating hormone (fsh) level in the postmenopausal range (fsh > 40 u/ml at screening) must be used to confirm a postmenopausal state. 5. male subject must agree to stay abstinent or must use together with his female partner(s) use a form of highly effective contraceptive from the time of signing the informed consent form (icf) until up to 3 months after receiving the study drug. 6. nonsmokers (and/or no use of other nicotine products during 1 year before screening visit). 7. body mass index (bmi) between 18.0 and 32.0 kg/m2, inclusive, at the screening visit. 8. healthy with no clinically significant findings, determined by medical evaluation (medical history, physical examination, vital signs, 12-lead ecg, and clinical laboratory evaluations) at screening. 9. forced expiratory volume in 1 second (fev1) ≥80%.