臨床研究等提出・公開システム

RGB-19 Phase I Clinical Study

RGB-19 Phase I Clinical Study

110

ALL participants were healthy Japanese male volunteers. The mean (SD) age was 29.5 (6.2) years, mean (SD) height was 170.75 (5.28) cm, mean body weight (SD) was 61.91 (6.25) kg, and mean (SD) BMI was 21.22 (1.79) kg/m2.

Participants in sequence A received RGB-19 in period 1, then switched to tocilizumab in period 2, whilst participants in sequence B received tocilizumab in period 1, then RGB-19 in period 2. The PK analysis set included participants who received the full dose of investigational product, could have either Cmax or AUCinf calculated, and had no major protocol deviations that could impact PK results. A total of 110 participants were randomised in period 1 and received investigational product (sequences A (RGB-19) and B (RoActemra), n = 55 each). In period 2, a total of 102 participants received the investigational product (sequence A, n = 49; sequence B, n =53), and all of them were included in the PK analysis set. In total, 8 (7.3%) participants prematurely withdrew from the study, all occurring during period 1. In sequence A (RGB-19), 6 (10.9%) participants withdrew: 3 (5.5%) due to AEs, 2 (3.6%) of which were ADRs, and 3 (5.5%) due to 'other reasons (positive smoking test result)'. Two participants withdrew in sequence B (RoActemra), 1 due to 'a positive drug or alcohol test' and 1 due to 'other reasons (positive smoking test result)'.

An AE occurring on or after the first treatment administration was considered a treatment-emergent adverse event (TEAE). In total, 51 (47.2%) participants experienced 76 TEAEs after receiving RGB-19 and 53 (51.0%) participants experienced 78 TEAEs after receiving tocilizumab. There were 36 (33.3%) participants receiving RGB-19 and 45 (43.3%) of participants receiving tocilizumab who experienced ADRs. No AEs resulting in death, serious ADRs/TEAEs, or severe ADRs/TEAEs were reported during the study. Participants in both groups experienced decreased neutrophil count TEAEs (RGB-19: 28 events in 27/108 [25.0%] participants; tocilizumab: 36 events in 36/104 [34.6%] participants). However, there were no notable differences observed between groups in the mean absolute neutrophil count (ANC) over time or the incidence of infections and infestations between groups (RGB-19:10 events in 9/108 [8.3%] participants; tocilizumab: 7 events in7/104 [6.7%] participants). No participants experienced injection site tenderness or induration/swelling. Two (1.9%) participants experienced injection pain 1 hour after RGB-19 administration, 1 (0.9%) of whom also experienced injection pain at 2 hours after RGB-19 administration. Twelve hours after tocilizumab administration, 1 (1.0%) participant experienced injection site erythema/redness. All injection site reactions were of mild severity and were deemed to be ADRs by the investigator, and all resolved. There were no reports of diverticulitis or perforations during the study. No new safety signals were identified, and AE profiles were similar between treatments.

PK equivalence was demonstrated between RGB-19 and tocilizumab for Cmax and AUCinf, with geometric mean ratio (GMR) for both outcomes within the predefined equivalence threshold of 0.80 to 1.25 (Cmax: point estimate: 1.04 [90% CI: 0.98-1.10]; AUCinf: point estimate: 1.05 [90% CI: 0.97-1.13]). There were no notable treatment differences in the mean or median values of secondary PK parameters. The secondary PK GMR point estimates all met the predefined equivalence threshold of 0.80 to 1.25, further demonstrating the similarity between treatments.

This study demonstrates the equivalence of RGB-19 and reference tocilizumab, showing that both treatments exhibit comparable PK, PD, immunogenicity, and safety outcomes.

Aug. 31, 2026

Sept. 24, 2025

https://pubmed.ncbi.nlm.nih.gov/42368616/

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031230029

Karibe Yusuke

Mochida Pharmaceutical Co., Ltd.

7, Yotsuya 1-chome, Shinjuku-ku, Tokyo

clinical.trials.contact@mochida.co.jp

Public relations

Mochida Pharmaceutical Co., Ltd.

7, Yotsuya 1-chome, Shinjuku-ku, Tokyo

+81-3-3225-6303

webmaster@mochida.co.jp

Complete

May. 01, 2023

Interventional

randomized controlled trial

double blind

active control

crossover assignment

treatment purpose

Male volunteers who voluntarily wish to participate in the study, have the capacity to provide consent, and have provided written informed consent to participate in the study.
Volunteers from 20 to 40 years of age (both inclusive) when signing informed consent.

Volunteers previously exposed to tocilizumab, any other IL-6 inhibitors, or IL-6 receptor inhibitors.

Male

Healthy Participants

RGB-19 injection or Tocilizumab injection

Maximum serum drug concentration (Cmax)
AUC from 0 hours (immediately before administration) to infinity (AUCinf)

+81-3-5213-0028

April. 24, 2023

none