日本人健康成人男性を対象に,MT-3921又はプラセボを静脈内投与した際の安全性,忍容性及び薬物動態を検討する. | |||
1 | |||
2022年07月01日 | |||
2022年08月03日 | |||
2022年08月03日 | |||
2022年12月24日 | |||
|
10 | ||
|
介入研究 | Interventional | |
Study Design |
|
無作為化比較 | randomized controlled trial |
|
二重盲検 | double blind | |
|
プラセボ対照 | placebo control | |
|
並行群間比較 | parallel assignment | |
|
その他 | other | |
|
あり | ||
|
あり | ||
|
あり | ||
|
|||
|
なし | none | |
|
|
この他にもいくつかの選択基準が適用される場合があります - 日本人健康成人男性 - 同意取得時の年齢が18 歳以上55 歳以下の者 - 本治験の内容を十分理解し,本治験への参加を文書にて同意した者 |
Additional screening criteria check may apply for qualification: - Japanese healthy adult males - Subjects aged between 18 and 55 years inclusive at the time of informed consent - Subjects with a full understanding of the nature of this study who have consented in writing to participate in the study |
|
この他にもいくつかの選択基準が適用される場合があります - 心臓,肝臓,腎臓,消化器系,呼吸器系,精神・神経系,造血器系又は内分泌系等疾患の既往歴,現病歴又は治療歴を有し,治験責任(分担)医師が不適格と判断した者 - 薬物又は食物アレルギーの既往を有する者(アナフィラキシー又は重大なアレルギーを含む) - 事前検査又はDay -1検査時にBMIが18.5未満又は25を超える者,又は体重が50 kg未満又は80 kgを超える者 - 同意取得前12週以内に合計400 mL以上,4週以内に合計200 mL以上又は1年以内に合計800 mL以上の献血又は採血を行った者 - 同意取得前2週以内に成分献血又は成分採血を行った者 - 薬物依存,アルコール依存の既往を有する又は現在症状がある者 - 12誘導心電図検査にて,臨床的に問題となる異常所見が認められた者,QTcF間隔が450 msec以上の者,又は聴診で臨床的に問題となる異常所見が認められた者 - 事前検査でHBs抗原,梅毒血清反応,HCV抗体又はHIV抗原・抗体が陽性の者 - COVID-19のPCR検査が陽性の者 - 突然死の家族歴がある者 - スクリーニング期間のC-SSRS評価にて,自殺念慮又は自殺企図のいずれかの項目に「はい」と回答した者 - 治験期間中,避妊することに同意が得られない者 - 過去に本剤を含む抗RGMa抗体の投与を受けた者 - 同意取得前12週以内に他の治験に参加し,治験薬の投与を受けた者 - 今回用いられている治験薬以外の薬剤を,治験薬投与開始前7日以内又は当該薬剤の半減期の5倍のうちいずれか長い期間内に使用した者 |
Additional screening criteria check may apply for qualification: - Subjects with or having a history or treatment history of disorders, including cardiac, hepatic, renal, gastrointestinal, respiratory, neuropsychiatric, hematopoietic, or endocrine system disorder, who are judged by the investigator (or subinvestigator) to be unfit for study participation - Subjects with a history of drug or food allergies, including anaphylaxis or significant allergic reactions - Subjects with a body mass index (BMI) of less than 18.5 kg/m^2 or greater than 25 kg/m^2 at the time of screening or Day -1 or those with a body weight of less than 50 kg or greater than 80 kg - Subjects who have donated blood or from whom blood samples have been collected in a total amount of 400 mL or more within 12 weeks prior to informed consent, 200 mL or more within 4 weeks prior to informed consent, or 800 mL or more within 1 year prior to informed consent - Subjects who have donated blood component or platelet apheresis within 2 weeks prior to informed consent - Subjects with or having a history of drug dependence or alcohol dependence - Subjects with clinically significant abnormalities on a 12-lead ECG, with a Fridericia-corrected QT (QTcF) interval of >= 450 msec, or with clinically significant abnormalities on an auscultation - Subjects with a positive result for hepatitis B virus surface (HBs) antigen, serological test for syphilis, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen/antibody at screening - Subjects with a positive polymerase chain reaction (PCR) test for Coronavirus disease 2019 (COVID-19) - Subjects with a family history of sudden death - Subjects who answered 'yes' to any of the items of suicide ideation or suicide attempts in the Columbia Suicide Rating Scale (C-SSRS) assessment in the screening period - Subjects who do not agree to practice contraception during the study period - Subjects who have previously received anti-RGMa antibodies, including this investigational product - Subjects who have participated in other clinical studies and received other investigational products within 12 weeks before informed consent - Subjects who have used any drug other than the investigational product in the period within 7 days before the start of investigational product administration or 5 times the half-life of the drug, whichever is longer |
|
|
18歳 以上 | 18age old over | |
|
55歳 以下 | 55age old under | |
|
男性 | Male | |
|
|||
|
急性期外傷性脊髄損傷、ヒトT細胞白血病ウイルス1型(HTLV-1)関連脊髄症(HAM) | Acute Traumatic Cervical Spinal Cord Injury, HTLV-1-Associated Myelopathy (HAM) | |
|
|||
|
|||
|
あり | ||
|
治験薬(MT-3921又はプラセボ)を,静脈内投与する. | MT-3921 or placebo will be administrated intravenously. | |
|
|||
|
|||
|
有害事象及び副作用 血清中MT-3921濃度 |
Percentage of subjects with adverse events Percentage of subjects with adverse reactions Serum concentrations of MT-3921 |
|
|
|
医薬品 | ||
---|---|---|---|
|
未承認 | ||
|
|
|
Unasnemab |
|
なし | ||
|
なし | ||
|
|
||
|
|
---|
|
||
---|---|---|
|
研究終了 |
Complete |
|
|
||
---|---|---|
|
|
|
|
||
|
|
田辺三菱製薬株式会社 |
---|---|
|
Mitsubishi Tanabe Pharma Corporation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
なし | |
---|---|---|
|
||
|
|
特定非営利活動法人臨床研究の倫理を考える会治験審査委員会 | Review Board of Human Rights and Ethics for Clinical Studies Institutional Review Board |
---|---|---|
|
東京都中央区京橋二丁目2番1号 | 2-2-1 Kyobashi, Chuo-ku, Tokyo |
|
03-5213-0028 | |
|
soudan@hurecs.org | |
|
||
|
承認 |
|
NCT05396235 |
---|---|
|
ClincialTrials.gov |
|
|
|
|
---|---|---|
|
||
|
||
|
|
無 | No |
---|---|---|
|
|
|
---|---|
|
|
|
|
設定されていません |
---|---|
|
設定されていません |