A Study to Assess the Adverse Events and How Oral ABBV-1606 Moves Through the Body of Healthy Adult Participants.
A First-in-Human Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABBV-1606 in Healthy Adult Subjects
This study will assess the adverse events, tolerability, and how oral ascending doses of ABBV-1606 moves through the body of healthy adult participants.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：ABBVIE CALL CENTER
- 電話番号：844-663-3742
- メール：abbvieclinicaltrials@abbvie.com
研究場所
-
-
Illinois
-
Grayslake、Illinois、アメリカ、60030
- Acpru /Id# 277795
-
-
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:
- BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- Total body weight > 50.0 kg at Screening.
- A condition of general good health, based upon the results of a medical history, physical examination, neurological examination, vital signs, laboratory profile, and a 12-lead ECG.
Exclusion Criteria:
- History of any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, immunological, neurological, pulmonary, metabolic, endocrine or psychiatric disease or disorder, active or chronic infectious diseases or any uncontrolled medical illness.
- History of any vasculitis-related conditions, or any confirmed autoimmune or connective tissue diseases (e.g., Systemic Lupus Erythematosus, Sjogren's Syndrome, inflammatory bowel disease, etc.) as per the Investigator judgement.
- History of unexplained purpura or skin rash, or unexplained signs or symptoms suggestive of vasculitis (including, but not limited to, fever, weight loss, arthralgia or arthritis, myalgia, hematuria, abdominal pain, gastrointestinal bleeding, etc.) that is not resolved for at least 30 days prior to dosing.
- History of any abnormal result for Antinuclear antibody (ANA) or Antineutrophil cytoplasmic antibody (ANCA) at Screening
- Abnormal result for C-Reactive Protein (CRP) or Erythrocyte Sedimentation Rate (ESR), or fibrinogen > the Upper limit of normal (ULN) at Screening.
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：基礎科学
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- 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：ABBV-1606 or Placebo Group 1
Participants will receive a single oral dose of ABBV-1606 or placebo group 1 on day 1. |
Oral Solution Oral Solution |
|
実験的：ABBV-1606 or Placebo Group 2
Participants will receive a single oral dose of ABBV-1606 or placebo group 2 on day 1. |
Oral Solution Oral Solution |
|
実験的：ABBV-1606 or Placebo Group 3
Participants will receive a single oral dose of ABBV-1606 or placebo group 3 on day 1. |
Oral Solution Oral Solution |
|
実験的：ABBV-1606 or Placebo Group 4
Participants will receive a single oral dose of ABBV-1606 or placebo group 4 on day 1. |
Oral Solution Oral Solution |
|
実験的：ABBV-1606 or Placebo Group 5
Participants will receive a single oral dose of ABBV-1606 or placebo group 5 on day 1. |
Oral Solution Oral Solution |
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 Experiencing Adverse Events
時間枠：Up to approximately 35 days
|
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment |
Up to approximately 35 days
|
|
Maximum observed plasma concentration (Cmax) of ABBV-1606
時間枠：Up to approximately 5 days
|
Cmax of ABBV-1606 |
Up to approximately 5 days
|
|
Time to maximum observed plasma concentration (Cmax) (Tmax) of ABBV-1606
時間枠：Up to approximately 5 days
|
Tmax of ABBV-1606 |
Up to approximately 5 days
|
|
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCt) of ABBV-1606
時間枠：Up to approximately 5 days
|
AUCt of ABBV-1606 |
Up to approximately 5 days
|
|
Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of ABBV-1606
時間枠：Up to approximately 5 days
|
AUCinf of ABBV-1606 |
Up to approximately 5 days
|
|
Apparent terminal phase elimination constant (β) of ABBV-1606
時間枠：Up to approximately 5 days
|
β of ABBV-1606 |
Up to approximately 5 days
|
|
Terminal Phase Elimination Half-Life (t1/2) of ABBV-1606
時間枠：Up to approximately 5 days
|
t1/2 of ABBV-1606 |
Up to approximately 5 days
|
|
Apparent clearance (CL/F) of ABBV-1606
時間枠：Up to approximately 5 days
|
CL/F of ABBV-1606 |
Up to approximately 5 days
|
|
Apparent volume of distribution (Vz/F) of ABBV-1606
時間枠：Up to approximately 5 days
|
Vz/F of ABBV-1606 |
Up to approximately 5 days
|
|
Dose Normalized Cmax of ABBV-1606
時間枠：Up to approximately 5 days
|
Dose Normalized Cmax of ABBV-1606 will be assessed. |
Up to approximately 5 days
|
|
Dose Normalized AUC of ABBV-1606
時間枠：Up to approximately 5 days
|
Dose Normalized AUC of ABBV-1606 will be assessed. |
Up to approximately 5 days
|
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：ABBVIE INC.、AbbVie
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
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