Number of participants with Treatment Emergent Adverse Events (TEAEs) in SAD
An adverse event (AE) is any untoward medical occurrence in a subject administered an IP, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product (IP) whether or not considered related to the IP. A TEAE is defined as an AE observed after starting administration of the study drug through end of study visit. A drug-related TEAE is defined as any TEAE with a causal relationship assessed as "yes" by the investigator.
Number of participants with TEAEs of special interest in SAD
AEs of special interest include cholesteatoma or ear neoplasm, ototoxic symptoms (tinnitus, sensorineural hearing loss, dizziness) and otitis media or otitis externa.
Change from baseline in bone conduction hearing at 1 kHz by pure tone audiometry (PTA) in SAD
PTA is a behavioral test and generally the 1st quantitative hearing test done to assess the nature and degree of hearing loss in adults and in children. This measure involves the peripheral and central auditory systems. Pure tone air conduction and bone conduction tests determine whether or not there is any hearing loss; what type of hearing loss it is (conductive, sensorineural or mixed hearing loss); the frequencies that are affected (configuration); magnitude of hearing loss (intensity) and whether hearing loss is unilateral or bilateral. The result is plotted on an audiogram, which is a graph displaying intensity as a function of frequency.
Change from baseline in bone conduction hearing at 2 kHz by pure tone audiometry (PTA) in SAD
PTA is a behavioral test and generally the 1st quantitative hearing test done to assess the nature and degree of hearing loss in adults and in children. This measure involves the peripheral and central auditory systems.
Change from baseline in bone conduction hearing at 4 kHz by pure tone audiometry (PTA) in SAD
PTA is a behavioral test and generally the 1st quantitative hearing test done to assess the nature and degree of hearing loss in adults and in children. This measure involves the peripheral and central auditory systems.
Change from baseline in Tinnitus Visual Analog Scale (TVAS) in SAD
TVAS is a scale for tinnitus loudness. Participants will be asked to rate their tinnitus on a scale of 0 to 10, where 0 means not at all strong or loud and 10 means extremely strong or loud tinnitus. A lower score means an improvement in tinnitus loudness.
Number of participants with Treatment Emergent Adverse Events (TEAEs) in single dose expansion
An AE is any untoward medical occurrence in a subject administered an IP, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product (IP) whether or not considered related to the IP. A TEAE is defined as an AE observed after starting administration of the study drug through end of study visit. A drug-related TEAE is defined as any TEAE with a causal relationship assessed as "yes" by the investigator.
Number of incidences of AEs of special interest in single dose expansion
AEs of special interest include cholesteatoma or ear neoplasm, ototoxic symptoms (tinnitus, sensorineural hearing loss, dizziness) and otitis media or otitis externa.
Change from baseline in bone conduction hearing at 1 kHz by pure tone audiometry (PTA) in single dose expansion
PTA is a behavioral test and generally the 1st quantitative hearing test done to assess the nature and degree of hearing loss in adults and in children. This measure involves the peripheral and central auditory systems. Pure tone air conduction and bone conduction tests determine whether or not there is any hearing loss; what type of hearing loss it is (conductive, sensorineural or mixed hearing loss); the frequencies that are affected (configuration); magnitude of hearing loss (intensity) and whether hearing loss is unilateral or bilateral. The result is plotted on an audiogram, which is a graph displaying intensity as a function of frequency.
Change from baseline in bone conduction hearing at 2 kHz by pure tone audiometry (PTA) in single dose expansion
PTA is a behavioral test and generally the 1st quantitative hearing test done to assess the nature and degree of hearing loss in adults and in children. This measure involves the peripheral and central auditory systems.
Change from baseline in bone conduction hearing at 4 kHz by pure tone audiometry (PTA) in single dose expansion
PTA is a behavioral test and generally the 1st quantitative hearing test done to assess the nature and degree of hearing loss in adults and in children. This measure involves the peripheral and central auditory systems.
Change from baseline in Tinnitus Visual Analog Scale (TVAS) in single dose expansion
TVAS is a scale for tinnitus loudness. Participants will be asked to rate their tinnitus on a scale of 0 to 10, where 0 means not at all strong or loud and 10 means extremely strong or loud tinnitus. A lower score means an improvement in tinnitus loudness.
Number of participants with Treatment Emergent Adverse Events (TEAEs) in MAD
AE is any untoward medical occurrence in a subject administered an IP, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product (IP) whether or not considered related to the IP. A TEAE is defined as an AE observed after starting administration of the study drug through end of study visit. A drug-related TEAE is defined as any TEAE with a causal relationship assessed as "yes" by the investigator.
Number of participants with TEAEs of special interest in MAD
AEs of special interest include cholesteatoma or ear neoplasm, ototoxic symptoms (tinnitus, sensorineural hearing loss, dizziness) and otitis media or otitis externa.
Change from baseline in bone conduction hearing at 1 kHz by pure tone audiometry (PTA) in MAD
PTA is a behavioral test and generally the 1st quantitative hearing test done to assess the nature and degree of hearing loss in adults and in children. This measure involves the peripheral and central auditory systems. Pure tone air conduction and bone conduction tests determine whether or not there is any hearing loss; what type of hearing loss it is (conductive, sensorineural or mixed hearing loss); the frequencies that are affected (configuration); magnitude of hearing loss (intensity) and whether hearing loss is unilateral or bilateral. The result is plotted on an audiogram, which is a graph displaying intensity as a function of frequency.
Change from baseline in bone conduction hearing at 2 kHz by pure tone audiometry (PTA) in MAD
PTA is a behavioral test and generally the 1st quantitative hearing test done to assess the nature and degree of hearing loss in adults and in children. This measure involves the peripheral and central auditory systems.
Change from baseline in bone conduction hearing at 4 kHz by pure tone audiometry (PTA) in MAD
PTA is a behavioral test and generally the 1st quantitative hearing test done to assess the nature and degree of hearing loss in adults and in children. This measure involves the peripheral and central auditory systems.
Change from baseline in Tinnitus Visual Analog Scale (TVAS) in MAD
TVAS is a scale for tinnitus loudness. Participants will be asked to rate their tinnitus on a scale of 0 to 10, where 0 means not at all strong or loud and 10 means extremely strong or loud tinnitus. A lower score means an improvement in tinnitus loudness.
Number of participants with Treatment Emergent Adverse Events (TEAEs) in multiple dose expansion
An AE is any untoward medical occurrence in a subject administered an IP, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of investigational product (IP) whether or not considered related to the IP. A TEAE is defined as an AE observed after starting administration of the study drug through end of study visit. A drug-related TEAE is defined as any TEAE with a causal relationship assessed as "yes" by the investigator.
Number of incidences of AEs of special interest in multiple dose expansion
AEs of special interest include cholesteatoma or ear neoplasm, ototoxic symptoms (tinnitus, sensorineural hearing loss, dizziness) and otitis media or otitis externa.
Change from baseline in bone conduction hearing at 1 kHz by pure tone audiometry (PTA) in multiple dose expansion
PTA is a behavioral test and generally the 1st quantitative hearing test done to assess the nature and degree of hearing loss in adults and in children. This measure involves the peripheral and central auditory systems. Pure tone air conduction and bone conduction tests determine whether or not there is any hearing loss; what type of hearing loss it is (conductive, sensorineural or mixed hearing loss); the frequencies that are affected (configuration); magnitude of hearing loss (intensity) and whether hearing loss is unilateral or bilateral. The result is plotted on an audiogram, which is a graph displaying intensity as a function of frequency.
Change from baseline in bone conduction hearing at 2 kHz by pure tone audiometry (PTA) in multiple dose expansion
PTA is a behavioral test and generally the 1st quantitative hearing test done to assess the nature and degree of hearing loss in adults and in children. This measure involves the peripheral and central auditory systems.
Change from baseline in bone conduction hearing at 4 kHz by pure tone audiometry (PTA) in multiple dose expansion
PTA is a behavioral test and generally the 1st quantitative hearing test done to assess the nature and degree of hearing loss in adults and in children. This measure involves the peripheral and central auditory systems.
Change from baseline in Tinnitus Visual Analog Scale (TVAS) in multiple dose expansion
TVAS is a scale for tinnitus loudness. Participants will be asked to rate their tinnitus on a scale of 0 to 10, where 0 means not at all strong or loud and 10 means extremely strong or loud tinnitus. A lower score means an improvement in tinnitus loudness.
Proportion of participants with complete closure of Tympanic Membrane Perforation (TMP) in SAD
Tympanic membrane perforation is a perforation of tympanic membrane in the ear. TMP closure is defined as microscopic TMP closure without presence of pin hole. All images from each visit will be sent to a central imaging vendor for measurement and interpretation.
Change from baseline in the ratio of TMP size per total area of tympanic membrane in SAD
Ratio of TMP size per total area of tympanic membrane will be calculated.
Change from baseline in TMP size in SAD
TMP size calculation will be performed by central imaging vendor.
Proportion of participants with complete closure of TMP in single dose expansion
Tympanic membrane perforation is a perforation of tympanic membrane in the ear. TMP closure is defined as microscopic TMP closure without presence of pin hole. All images from each visit will be sent to a central imaging vendor for measurement and interpretation.
Change from baseline in the ratio of TMP size per total area of tympanic membrane in single dose expansion
Ratio of TMP size per total area of tympanic membrane will be calculated.
Change from baseline in TMP size in single dose expansion
TMP size calculation will be performed by central imaging vendor.
Proportion of participants with complete closure of TMP in MAD
Tympanic membrane perforation is a perforation of tympanic membrane in the ear. TMP closure is defined as microscopic TMP closure without presence of pin hole. All images from each visit will be sent to a central imaging vendor for measurement and interpretation.
Change from baseline in TMP size in MAD
TMP size calculation will be performed by central imaging vendor.
Change from baseline in the ratio of TMP size per total area of tympanic membrane in MAD
Ratio of TMP size per total area of tympanic membrane will be calculated.
Proportion of participants with complete closure of TMP in multiple dose expansion
Tympanic membrane perforation is a perforation of tympanic membrane in the ear. TMP closure is defined as microscopic TMP closure without presence of pin hole. All images from each visit will be sent to a central imaging vendor for measurement and interpretation.
Change from baseline in the ratio of TMP size per total area of tympanic membrane in multiple dose expansion
Ratio of TMP size per total area of tympanic membrane will be calculated.
Change from baseline in TMP size in multiple dose expansion
TMP size calculation will be performed by central imaging vendor.