TriangleNCT04442126 · OUTCOME
Assessment of the Maximum Observed Serum Concentration Determined by Direct Inspection of the Concentration Versus Time Data (Cmax)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- From baseline to up to 12 weeks post last dose, up to 48 weeks.
Analysis population: Cmax determined at C1 for all dose levels with the exception of Part A Dose Level 1 which has been noted as NA ,for which was BLQ. Lower limit of quantification (LLOQ) of NM21-1480 = 5 ng/mL.
Groups in this outcome
Part A Dose Level 1 NM21-1480-Q2W 0.15mg
Flat dose level; 0.15mg (Dose Level 1)
Part A Dose Level 2 NM21-1480-Q2W 1.5mg
Flat dose level; 1.5mg (Dose Level 2)
Part A Dose Level 3 NM21-1480-Q2W 8mg
Flat dose level; 8mg (Dose Level 3)
Part A Dose Level 4 NM21-1480-Q2W 24mg
Flat dose level; 24mg (Dose Level 4)
Part A Dose Level 5 NM21-1480-Q2W 80mg
Flat dose level; 80mg (Dose Level 5)
Part A Dose Level 6 NM21-1480-Q2W 240mg
Flat dose level; 240mg (Dose Level 6)
Part A Dose Level 7 NM21-1480-Q2W 800mg
Flat dose level; mg800 (Dose Level 7)
Part A2 NM21-1480-Q2W
This part of the study consisted of a 1400mg flat dose across one cohort.
Part B NM21-1480-Q2W
This part of the study consisted of a 800mg flat dose across three cohorts.
| Group | Source count |
|---|---|
| Part A Dose Level 1 NM21-1480-Q2W 0.15mg | 1 |
| Part A Dose Level 2 NM21-1480-Q2W 1.5mg | 1 |
| Part A Dose Level 3 NM21-1480-Q2W 8mg | 3 |
| Part A Dose Level 4 NM21-1480-Q2W 24mg | 3 |
| Part A Dose Level 5 NM21-1480-Q2W 80mg | 6 |
| Part A Dose Level 6 NM21-1480-Q2W 240mg | 3 |
| Part A Dose Level 7 NM21-1480-Q2W 800mg | 8 |
| Part A2 NM21-1480-Q2W | 4 |
| Part B NM21-1480-Q2W | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A Dose Level 1 NM21-1480-Q2W 0.15mg | NA | NA | Not reported | Not reported | BLQ |
| Part A Dose Level 2 NM21-1480-Q2W 1.5mg | 184.3 | 184.3 | Not reported | Not reported | Not reported |
| Part A Dose Level 3 NM21-1480-Q2W 8mg | 1604 | 1101 | Not reported | Not reported | Not reported |
| Part A Dose Level 4 NM21-1480-Q2W 24mg | 6334 | 2331 | Not reported | Not reported | Not reported |
| Part A Dose Level 5 NM21-1480-Q2W 80mg | 19800 | 5576 | Not reported | Not reported | Not reported |
| Part A Dose Level 6 NM21-1480-Q2W 240mg | 66890 | 43340 | Not reported | Not reported | Not reported |
| Part A Dose Level 7 NM21-1480-Q2W 800mg | 204700 | 32070 | Not reported | Not reported | Not reported |
| Part A2 NM21-1480-Q2W | 420300 | 12040 | Not reported | Not reported | Not reported |
| Part B NM21-1480-Q2W | 258500 | 65390 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- BLQ
- group Id
- OG000
- spread
- NA
- value
- NA
- group Id
- OG001
- spread
- 184.3
- value
- 184.3
- group Id
- OG002
- spread
- 1101
- value
- 1604
- group Id
- OG003
- spread
- 2331
- value
- 6334
- group Id
- OG004
- spread
- 5576
- value
- 19800
- group Id
- OG005
- spread
- 43340
- value
- 66890
- group Id
- OG006
- spread
- 32070
- value
- 204700
- group Id
- OG007
- spread
- 12040
- value
- 420300
- group Id
- OG008
- spread
- 65390
- value
- 258500
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 9
- units
- Participants
- dispersion Type
- Standard Deviation
- groups
- description
- Flat dose level; 0.15mg (Dose Level 1)
- id
- OG000
- title
- Part A Dose Level 1 NM21-1480-Q2W 0.15mg
- description
- Flat dose level; 1.5mg (Dose Level 2)
- id
- OG001
- title
- Part A Dose Level 2 NM21-1480-Q2W 1.5mg
- description
- Flat dose level; 8mg (Dose Level 3)
- id
- OG002
- title
- Part A Dose Level 3 NM21-1480-Q2W 8mg
- description
- Flat dose level; 24mg (Dose Level 4)
- id
- OG003
- title
- Part A Dose Level 4 NM21-1480-Q2W 24mg
- description
- Flat dose level; 80mg (Dose Level 5)
- id
- OG004
- title
- Part A Dose Level 5 NM21-1480-Q2W 80mg
- description
- Flat dose level; 240mg (Dose Level 6)
- id
- OG005
- title
- Part A Dose Level 6 NM21-1480-Q2W 240mg
- description
- Flat dose level; mg800 (Dose Level 7)
- id
- OG006
- title
- Part A Dose Level 7 NM21-1480-Q2W 800mg
- description
- This part of the study consisted of a 1400mg flat dose across one cohort.
- id
- OG007
- title
- Part A2 NM21-1480-Q2W
- description
- This part of the study consisted of a 800mg flat dose across three cohorts.
- id
- OG008
- title
- Part B NM21-1480-Q2W
- param Type
- MEAN
- population Description
- Cmax determined at C1 for all dose levels with the exception of Part A Dose Level 1 which has been noted as NA ,for which was BLQ. Lower limit of quantification (LLOQ) of NM21-1480 = 5 ng/mL.
- reporting Status
- POSTED
- time Frame
- From baseline to up to 12 weeks post last dose, up to 48 weeks.
- title
- Assessment of the Maximum Observed Serum Concentration Determined by Direct Inspection of the Concentration Versus Time Data (Cmax)
- type
- SECONDARY
- unit Of Measure
- ng/mL
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Preserved source evidence · Not medical advice