SA030 Injection in Healthy Participants
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-dose Escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of SA030 Injection in Healthy Participants
This is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of single ascending doses of SA030 injection in healthy participants. The planned dose levels include 100 mg, 200 mg, and 400 mg, with 8 eligible participants enrolled in each dose group.
All participants receive a single administration of the study drug on Day 1 (D1). In each dose group, the first 2 participants are enrolled as sentinel participants and randomized at a 1:1 ratio to receive either SA030 injection or placebo. After a 5-day safety observation period and favorable safety assessment by the investigator, the remaining 6 participants in the group will be enrolled and randomized at a 5:1 ratio to receive SA030 injection or placebo.
For dose escalation, at least 6 out of 8 participants in each dose group must complete the 14-day safety observation period (up to Day 15 [D15]). Subsequent dose escalation to the next higher dose level can only be initiated after safety review and approval by the Safety Review Committee (SRC).
調査の概要
状態
条件
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：Hong Zhang
- 電話番号：+86 15298351869
- メール：zhanghong@siranbio.com
研究場所
-
-
Jilin
-
Changchun、Jilin、中国、130000
- The First Bethune Hospital of Jilin University
-
コンタクト：
- Hong Zhang
- 電話番号：+86 18186870853
- メール：jhongzhang@foxmail.com
-
-
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:
- Participants aged 18 to 55 years, with a BMI of 25-40 kg/m².
- Healthy participants as determined by medical history, physical examination, vital signs, ECG and laboratory assessments.
- Willing to use effective contraception and have no pregnancy plans from screening to 6 months after study drug administration and/or throughout the study, with no intent to donate sperm or ova.
Exclusion Criteria:
-
Medical history：
- Nervous, cardiovascular, hematologic/lymphatic, immune, gastrointestinal, renal, respiratory, endocrine disorders, history of malignancy, or psychiatric/psychological conditions
- Has hypertension at screening (blood pressure ≥150/95 mmHg), diabetes mellitus (FPG ≥7.0 mmol/L and/or HbA1c ≥7.0%), hyperlipidemia (LDL-C ≥4.9 mmol/L or TG ≥500 mg/dL (5.65 mmol/L)), or gout.
- Has a history of bleeding disorders, recent active bleeding, or clinically significant bleeding risk; or has coagulation abnormalities deemed clinically significant by the Investigator at screening.
- Tests positive for HBV, HCV, HIV, or syphilis (positive Treponema pallidum, excluding those with negative RPR).
- Has undergone major surgery within 6 months prior to screening, or plans to undergo surgery during the study period.
- Has severe infection or trauma within 4 weeks prior to screening.
- Has clinically significant hepatic space-occupying lesions, gallbladder lesions, pancreatic or renal abnormalities identified on abdominal ultrasound at screening.
- Has severe allergic diathesis.
- Has prior severe intolerance to subcutaneous injection.
- Has skin abnormalities at injection sites.
- Has risk factors for TdP, requires concurrent use of QT/QTc-prolonging / TdP-inducing drugs, or has high-risk bundle branch block.
-
Has clinically significant laboratory abnormalities at screening as judged by the Investigator.
-
concomitant medications：
- Has received live attenuated vaccine within 1 month prior to screening, or plans to receive live attenuated vaccine during the study period.
- Has used any prescription drugs, herbal medicines, or over-the-counter medications within 14 days prior to administration of the investigational product.
- Has used any over-the-counter medications, herbal medicines or dietary supplements that may significantly affect body weight or metabolism within 1 month prior to screening.
- Has participated in another drug clinical trial within 3 months prior to treatment in this study or within 5 half-lives of the other investigational product ; or has prior use of siRNA or antisense oligonucleotide drugs within 6 months prior to administration of the study drug.
-
Other
- Has non-physiological blood loss ≥ 400 mL within 1 month prior to screening (including trauma, blood sampling, blood donation), or plans to donate blood during the study or within 30 days after study drug administration.
- Has weekly alcohol intake >14 units within 3 months prior to screening ; or has a positive alcohol breath test on the day before dosing ; or is unable to abstain from alcohol during the in-hospital study period.
- Has current or history of illicit drug use/substance abuse, or tests positive on urine drug screen on the day prior to dosing.
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：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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：SA030 Injection, 100 mg
Single subcutaneous injection of SA030 at 100 mg dose, one-time administration. |
Single subcutaneous injection of SA030 injection at a dose of 100 mg, one-time administration on Day 1. |
|
実験的：SA030 Injection, 200mg
Single subcutaneous injection or SA030 at 200 mg dose, one-time administration. |
Single subcutaneous injection of SA030 injection at a dose of 200 mg, one-time administration on Day 1. |
|
実験的：SA030 Injection, 400mg
Single subcutaneous injection or SA030 at 400 mg dose, one-time administration. |
Single subcutaneous injection of SA030 injection at a dose of 400 mg, one-time administration on Day 1. |
|
プラセボコンパレーター：placebo
Single subcutaneous injection of placebo, one-time administration. |
Single subcutaneous injection of placebo, one-time administration. |
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 |
時間枠 |
|---|---|
|
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
時間枠：Approximatly 9 months
|
Approximatly 9 months
|
|
Number of participants with clinically significant laboratory abnormalities
時間枠：Approximatly 9 months
|
Approximatly 9 months
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Peak plasma concentration (Cmax)
時間枠：Pre-dose, multiple timepoints post-dose up to D15
|
Pre-dose, multiple timepoints post-dose up to D15
|
|
Time to peak plasma concentration (Tmax)
時間枠：Pre-dose, multiple timepoints post-dose up to D15
|
Pre-dose, multiple timepoints post-dose up to D15
|
|
Plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t)
時間枠：Pre-dose, multiple timepoints post-dose up to D15
|
Pre-dose, multiple timepoints post-dose up to D15
|
|
Elimination half-life (t1/2)
時間枠：Pre-dose, multiple timepoints post-dose up to D15
|
Pre-dose, multiple timepoints post-dose up to D15
|
|
Changes in BMI
時間枠：baseline, up to 9 months
|
baseline, up to 9 months
|
|
Changes in body fat content
時間枠：baseline, up to 9 months
|
baseline, up to 9 months
|
|
Changes in hepatic fat content
時間枠：baseline, up to 9 months
|
baseline, up to 9 months
|
|
Changes in ALK7 expression
時間枠：baseline, up to 9 months
|
baseline, up to 9 months
|
|
Number of participants with anti-SA030 antibodies (immunogenicity)
時間枠：baseline, up to 9 months
|
baseline, up to 9 months
|
|
Change in QTcF relative to baseline and relative to placebo compared to baseline
時間枠：Pre-dose, multiple timepoints post-dose up to Day 5
|
Pre-dose, multiple timepoints post-dose up to Day 5
|
協力者と研究者
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
本研究に関する用語
キーワード
その他の研究ID番号
- SAOB101-CN
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?
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
米国FDA規制機器製品の研究
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。