健康な参加者におけるUB-313の安全性、忍容性、免疫原性を評価する第1相試験
健康な参加者におけるUBITh®CGRP免疫療法（UB-313）の安全性、忍容性、および免疫原性を評価するための第1相無作為化、二重盲検、プラセボ対照、ファーストインヒューマン研究
This first in-human (FIH) study of UB-313, an anti-calcitonin gene-related peptide based immunotherapeutic candidate, is designed to assess the safety, tolerability, and immunogenicity of 4 selected UB-313 dose regimens in healthy adults.
調査の概要
詳細な説明
This is a single-site, randomized, double-blind, placebo-controlled, multidose regimen, FIH study of UB-313, an anti-CGRP peptide-based immunotherapy candidate. The double-blind period will include dose escalation and cohort staggering for up to 4 planned dose levels of UB-313 or placebo in 4 cohorts of healthy participants. All eligible participants will be enrolled in the study for up to 44 weeks, consisting of IM injections of UB-313 or placebo at Week 0 (Baseline, Day 1), Week 4, and Week 12. The End of Treatment (EoT) is defined as Week 16, followed by a follow-up period up to Week 44.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
-
Leuven、ベルギー
- Katholieke Universiteit Leuven
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Is a male or female aged 18 to 55 years old, inclusive, at time of informed consent.
- Has a body mass index between 18 and 30 kg/m2, inclusive at Screening, and with a minimum weight of 50 kg.
- Male participants and their partners of childbearing potential must commit to the use of highly effective contraceptives for the study duration and for at least 12 weeks after the last dose. Men must refrain from donating sperm during this same period.
- Female participants must be of nonchildbearing potential, or, for women of childbearing potential, must be willing to practice highly effective contraception throughout the duration of the study and for at least 24 weeks following the last dose.
- Other inclusion criteria apply
Exclusion Criteria:
- Has a history of clinically significant medical or psychiatric conditions, which in the opinion of the Investigator may compromise the participant's safety or the scientific value of the study, posing an unacceptable risk to the participant or interfere with the participant's ability to comply with study procedures or abide by study restrictions.
- Presents any concern by the Investigator regarding safe participation in the study or for any other reason (including contraindication to MRI) that the Investigator considers the participant inappropriate for participation in the study.
- Has a recent history (within the past year of Screening) of migraine headache.
- Has unsuitable skin characteristics for the dermal capsaicin challenge as determined by the Investigator.
- Has not demonstrated at least a 100% increase in dermal blood flow following capsaicin challenge as part of Screening procedures and measured through laser speckle contrast imaging.
- Other exclusion criteria apply
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：UB-313 Cohort 1
UB-313 100mcg administered by intramuscular (IM) injection at Week 0, Week 4 and Week 12 |
A synthetic peptide-based immunotherapy |
|
実験的：UB-313 Cohort 2
UB-313 300mcg administered by IM injection at Week 0 and 100mcg at Week 4 and Week 12 |
A synthetic peptide-based immunotherapy |
|
実験的：UB-313 Cohort 3
UB-313 300mcg administered by IM injection at Week 0, Week 4 and Week 12 |
A synthetic peptide-based immunotherapy |
|
実験的：UB-313 Cohort 4
UB-313 600mcg administered by IM injection at Week 0 and 100mcg at Week 4 and Week 12 |
A synthetic peptide-based immunotherapy |
|
プラセボコンパレーター：Placebo Comparator
Placebo (normal saline), administered by IM injection at Week 0, Week 4 and Week 12 |
Normal saline |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
時間枠：44 weeks
|
The number and percentage of participants with TEAEs were tabulated. |
44 weeks
|
|
Immunogenicity Measured by Serum Anti-CGRP Antibodies.
時間枠：Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, 28, 36 and 44; Week 0, Week 16 and Week 44 are reported
|
Immunogenicity measured by blood anti-CGRP antibody titers, reported as Optical Density (OD) of 1:25 dilution. |
Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, 28, 36 and 44; Week 0, Week 16 and Week 44 are reported
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pharmacodynamics of the Immune Response Measured by Capsaicin-induced Increase in Dermal Blood Flow
時間枠：Weeks 0, 4, 8, 12, 16, 20
|
Number of Participants with inhibition of capsaicin-induced increase in dermal blood flow |
Weeks 0, 4, 8, 12, 16, 20
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Medical Director, MD、Vaxxinity, Inc.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。