A MAD Study of TT301/MW189 in Healthy Volunteers
2020年6月2日 更新者：Linda Van Eldik
A Phase 1b, Double-Blind, Randomized, Placebo-Controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TT301/MW189 Administered Intravenously to Healthy Volunteers
The purpose of this Study is to find out whether an investigational drug is safe and well tolerated.
MW189 is being studied as a possible short-term treatment for people with different types of brain injury.
MW189 has previously been given to healthy human volunteers as a single dose, and there were no significant problems or bad effects in people who received the Study drug.
However, before it can be tested in people with brain injury, it is important to test MW189 in healthy volunteers when given multiple doses.
調査の概要
状態
完了
条件
詳細な説明
This is a phase 1b study. Written informed consent will be obtained from each study participant before any study-specific procedures or assessments are done.
At various time points noted below, pharmacokinetic (PK) blood sampling will be performed on study participants.
Throughout the study the investigator will be assessing adverse events and concomitant medication.
On-Study/On-Interventions Evaluations/procedures: Participants will arrive at the Phase 1 unit after fasting a minimum of 10 hours, for admission into the unit and will undergo procedures:
- Medical and medication histories
- Infection screen
- Body temperature
- Vital signs (blood pressure and heart rate)
- Physical examination and weight
- Neurological exam
- Safety laboratory tests (blood and urine)
- Urine pregnancy test (females only)
- Alcohol screening (Breathalyzer)
- Urine drug screen
- Hepatitis B, C and HIV screening
- Randomize: Only participants who meet eligibility requirements will be randomized into the study.
Day 1 - Dosing: A light breakfast will be given prior to dosing. Participants will have the following tests/procedures performed at various time points during the day following confirmation of eligibility.
- 8 electrocardiograms (ECG)
- 8 vital signs (blood pressure and heart rate)
- 1 body temperature
- 12 PK Blood draws
- 2 study drug administrations
Day 2: A light breakfast will be given prior to dosing.
- 8 ECGs
- 8 vital signs (blood pressure and heart rate)
- 1 body temperature
- 1 PK blood draw
- 2 study Drug administration
Day 3: Participants will fast for a minimum of 10 hours. Water is allowed. A Light breakfast will be given before dosing
- 1 safety laboratory tests (blood and urine)
- 1 ECG
- 2 vital signs (blood pressure and heart rate)
- 1 body temperature
- 1 PK blood draw
- 1 neurological examination
- 2 study drug administrations
Day 4: A Light breakfast will be given before dosing
- 2 vital signs (blood Pressure and heart rate)
- 1 body temperature
- 1 PK blood draw
- 2 study drug administrations
Day 5: A Light breakfast will be given before dosing
- 1 ECG
- 2 vital signs (Blood Pressure and heart rate)
- 1 body temperature
- 12 PK blood draw
- 2 study drug administration
Day 6: Participants will fast for a minimum of 10 hours. Water is allowed. A Light breakfast will be given
- 1 safety laboratory test (blood and urine)
- 1 vital sign (Blood pressure and heart rate)
- 1 body temperature
- 1 neurological examination
- 2 PK blood draw
Day 7: A light breakfast will be provided
- 1 vital sign
- 1 body temperature
- 1 PK blood draw
Day 8 (Discharge): Participants will fast for a minimum of 10 hours. Water is allowed. A light breakfast will be offered
- 1 safety laboratory test (blood and urine)
- 1 ECG
- 1 vital sign (blood pressure and heart rate)
- 1 body temperature
- 1 physical examination including weight
1 neurological examination
2 Week Follow-up Visit: Participants will fast for a minimum of 10 hours. Water is allowed.
during this visit participants will have the following tests and procedures performed:
- 1 safety laboratory test (blood and urine)
- 1 ECG
- 1 vital sign (blood pressure and heart rate)
- 1 body temperature
6-8 Week Follow-up Phone Call: Participants will be asked about any adverse events and any medications they may be taking.
研究の種類
介入
入学 (実際)
35
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
North Carolina
-
Durham、North Carolina、アメリカ、27710
- Duke Clinical Research Unit 40 Duke Medicine Circle
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～50年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Willingness and capacity to give informed consent
- Is in good health
- Weights 50.0 - 120.0 kg
- Not pregnant
- Must agree to use birth control for 1 week after the last day of study drug administration
- Willingness to comply with protocol requirements, including fasting, alcohol and nicotine restrictions, during the study and is available to complete the study
- Adequate forearm vein access
- No significant dietary restrictions
- Must not have donated blood, platelets, or any other blood components 30 days, or plasma 60 days, prior to consenting. Must also agree not to donate blood, platelets, or any other blood components for 8 weeks after the last dose of study drug
Exclusion Criteria:
- Lactating or is pregnant
- severe ischemic heart disease or congestive heart failure
- Heart attack within the previous 2 years;
- history of stroke or cardiomyopathy;
- significant liver or kidney disease;
- diabetes;
- history of any autoimmune disorder; or a history of chronic infections
- a history of cancer
- has received antibiotic treatment or has undergone a surgical procedure within 30 days of Day 1
- has a history of Hepatitis C, Hepatitis B or tuberculosis (TB)
- has a history of Human Immunodeficiency Virus (HIV)
- a history of alcohol or drug use within the twelve months prior to study drug administration
- has used any immunosuppressants or chronic anti-inflammatory drugs medication including prescription medication, over-the-counter medication, health/herbal supplement or vitamin by any route of administration within 7 days of Day 1
- has donated blood within 30 days of consenting or has donated plasma within 60 days of consenting
- has participated in a clinical trial of an immunosuppressive drug within 6 months of Day 1
- has received an investigational drug, used an investigational device or received an investigational medical procedure within 60 days of Day 1, or concurrent with participation in this study
- has participated in any observational studies, experimental studies of non-investigational drugs, devices, or medical procedures within 30 days of Day 1, or concurrent with participation in this study
- has participated in a previous trial with TT301/MW189
- has a history of unexplained syncope or fainting from the collection of blood; i.e., autonomic dysfunction.
- Lack of ability to understand verbal and/ or written English
- had significant trauma or surgical procedure within 1 month prior to Screening.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Cohort 1 - TT301/MW189
TT301/MW189 0.075 mg/kg IV (or matched placebo).
Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive
|
0.075 mg/kg IV twice daily on Days 1 through 5
他の名前：
|
|
実験的：Cohort 2 -TT301/MW189
TT301/MW189 0.15 mg/kg IV (or matched placebo).
Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive
|
0.15 mg/kg IV twice daily on Days 1 through 5
他の名前：
|
|
実験的：Cohort 3- TT301/MW189
TT301/MW189 0.25 mg/kg IV (or matched placebo).
Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive
|
0.25 mg/kg IV twice daily on Days 1 through 5
他の名前：
|
|
実験的：Cohort 4- TT301/MW189
TT301/MW189 0.30 mg/kg IV (or matched placebo).
Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive
|
0.30 mg/kg IV twice daily on Days 1 through 5
他の名前：
|
|
プラセボコンパレーター：Placebo
No drug intervention.
|
0.9% 塩化ナトリウム
|
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 |
|---|---|---|
|
Serious Adverse Events
時間枠：4 weeks
|
The number of participants who experienced serious adverse events.
|
4 weeks
|
|
Treatment-Emergent Adverse Events
時間枠：4 weeks
|
The number of participants who experienced treatment-emergent adverse events (TEAEs).
A TEAE is defined as an adverse event that started during the treatment period.
|
4 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pharmacokinetics - Cmax
時間枠：5 days
|
Maximum observed concentration in plasma.
|
5 days
|
|
Pharmacokinetics - Tmax
時間枠：5 days
|
Time to maximum concentration
|
5 days
|
|
Pharmacokinetics - AUC
時間枠：5 days
|
Area under the concentration-time curve
|
5 days
|
|
Pharmacokinetics - T1/2
時間枠：5 days
|
Terminal half-life (T1/2)
|
5 days
|
|
Pharmacokinetics - Kel
時間枠：5 days
|
Elimination rate constant
|
5 days
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディチェア：Linda J. Van Eldik, PhD、University of Kentucky
- 主任研究者：Jeffrey T. Guptill, MD, MA,MHS、Duke University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年3月20日
一次修了 (実際)
2018年6月4日
研究の完了 (実際)
2018年6月4日
試験登録日
最初に提出
2016年10月20日
QC基準を満たした最初の提出物
2016年10月21日
最初の投稿 (見積もり)
2016年10月24日
学習記録の更新
投稿された最後の更新 (実際)
2020年6月16日
QC基準を満たした最後の更新が送信されました
2020年6月2日
最終確認日
2020年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- TT301/MW189 Phase 1b
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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。