HV - healthy volunteers
SC - subcutaneous
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Note added at 43 мин (2021-10-18 17:24:34 GMT)
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Примечание к Таблице 3:
σIV=residual error multiplication factor for IV administration; σHV=residual error multiplication factor for HV SC administration; σST309=residual error multiplication factor for BN40900.

Двумя абзацами ранее указано:
The satralizumab population PK analysis was conducted in two stages. In Stage 1 (Report No. 1093049), the data from study SA-001JP (healthy subjects) were combined with data from patients with NMO/NMOSD receiving satralizumab in addition to baseline IST (BN40898) (up to 06 June 2018). A covariate analysis was performed after removing data from RA patients. In Stage 2 (Report No. 1094498), the data from the second Phase III study (BN40900) in patients receiving satralizumab as monotherapy (up to 12 October 2018) were combined with the Stage 1 dataset with additional PK data from the OLE of BN40898.

Хотя аббревиатура HV нигде больше, кроме как в этой таблице, в данном документе не встречается и в перечне сокращений не расшифровывается, но "healthy volunteers" встречаются на страницах 35 (In addition, two Phase I studies have been conducted in Japan, one in healthy volunteers (SA-001JG) and one in RA patients (SA-105JG).), 52 (Although initially the PK of satralizumab was to be studied using data from four clinical trials (one in healthy volunteers (Study SA-001JP), another one in patients with RA (Study SA-015JP) , and two in the target population (Study BN40898 and Study BN40900) , i.e. patients with NMO or NMOSD)... The final population PK model shows that the disposition of satralizumab can be described by a two-compartment model with parallel linear and Michaelis-Menten elimination, and that it depends on body weight, ADAs development, formulation (i.e. formulation for Phase I-III or market formulation) and disease status (Healthy volunteers vs patients with NMO/NMOSD)), 58 (Satralizumab dose finding was performed in two studies, including one Phase 1 single ascending dose study in Caucasian and Japanese healthy volunteers (SA-001JP) and one Phase 1b multiple dose study in Japanese RA patients (SA-105JP)) и 99 (In addition, supportive safety data are provided from 72 healthy volunteers (Study SA-001JP) and 33 RA patients (Study SA-105JP)).