First-In-Human (FIH), Single Ascending Dose (SAD) Study and Multiple Ascending Dose (MAD) Study of SP-101 Injection

Официальное название

A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of SP-101 Injection Following Single and Multiple Intravenous Doses in Healthy Adult Subjects

Обзор

The goal of this First-In-Human (FIH) trial is to learn about safety, tolerability and pharmacokinetics of single and multiple ascending doses of SP-101 in healthy adult volunteers.

Вмешательства

• Препарат SP-101 injection
  SP-101 is non-competitive antagonist against NMDA receptor and is administered by intravenous infusion.
• Препарат Placebo
  Participants will be randomly assigned to the experimental group and placebo groups at ratio of 3:1. Participants assigned to the experimental group will be administered SP-101 by intravenous infusion. Accordingly, participants assigned to the placebo group will be administered placebo by intravenous infusion.

Первичные конечные точки

• Treatment Emergent Adverse Events, throughout study completion [Срок оценки: Through study completion, an average of 10 days for SAD and an average of 28 days for MAD]

Вторичные конечные точки (7)

• Pharmacokinetic Parameter-AUC₀-inf [Срок оценки: From 0 hour before dosing to 72 hours after dosing]
• Pharmacokinetic Parameter-AUC₀-last [Срок оценки: From 0 hour before dosing to 72 hours after dosing]
• Pharmacokinetic Parameter-Cmax [Срок оценки: From 0 hour before dosing to 72 hours after dosing]
• Pharmacokinetic Parameter-Tmax [Срок оценки: From 0 hour before dosing to 72 hours after dosing]
• Pharmacokinetic Parameter-T½ [Срок оценки: From 0 hour before dosing to 72 hours after dosing]
• Pharmacokinetic Parameter-CL [Срок оценки: From 0 hour before dosing to 72 hours after dosing]
• Pharmacokinetic Parameter- Vz [Срок оценки: From 0 hour before dosing to 72 hours after dosing]

Критерии участия

Критерии включения

• Willing and able to sign written informed consent;
• Aged 18 to 45 years old (inclusive), healthy males or females (male-to-female ratio is 1:1);
• Efficient contraceptive mean required by the protocol, and no plans for fertility, sperm donation or egg donation until 3 months after the last intravenous infusion;
• Body weight:≥50 kg (Male),≥45 kg (Female), Body Mass Index (BMI) of 18 to 28 kg/m2;
• Normal laboratory tests results, physical examination, medical history and surgical history review, 12-lead Electrocardiogram recording, and with no evidence of active and chronic diseases;
• willing and able to comply with all study procedures, restrictions, and visit schedules and to communicate effectively with the investigator;

Критерии исключения

• Individuals with special dietary requirements who cannot adhere to a unified diet (e.g., intolerance to standard meal foods, or those with dysphagia);
• History of intolerance to IV infusion (e.g., severe pain) or unsuitable venous access (e.g., sclerotic, atrophic veins), difficulties with or contraindications to blood sampling; or a history of needle- or blood-injury-related phobia or syncope;
• Lactation or a positive pregnancy test at screening or baseline;
• Any febrile illness or active infection within 14 days prior to the first dose;
• Evidence of drug / substance abuse within the past 5 years, and/or habitual use of any drugs/substances, or a positive urine drug test at screening or baseline;
• Abnormal renal function (eGFR < 90 mL/min/1.73 m²);
• History of QTc prolongation or demonstration of a clinically relevant ECG abnormality at screening;
• Excessive consumption of nicotine products within 3 months prior to screening (average daily cigarette consumption >5 cigarettes), or inability to stop using any tobacco products during the trial, or a positive nicotine test;
• Previous participation in this study; treatment with an investigational product within 30 days prior to study initiation; or planning participation in another clinical trial during the study period;
• Positive test result at screening for any of the following: hepatitis B surface antigen (HBsAg), antibody to hepatitis C virus (anti-HCV), antibody to human immunodeficiency virus (anti-HIV), or treponemal antibody for syphilis;
• Any abnormal results during screening that is deemed clinically significant by the investigator, e.g., resting pulse <55 or >100 bpm; SBP ≥140 or <90 mmHg; DBP ≥100 or <60 mmHg, or ECG, or abnormal laboratory tests results, clinically relevant;
• Significant blood loss (≥200 mL) within 60 days prior to dosing（including trauma, blood sampling, blood donation, etc.）; or planning blood donation during the study or within 30 days post-dose;
• History of alcohol abuse, or average weekly alcohol consumption greater than 14 units within 3 months prior to screening or a positive alcohol breath test at baseline or inability to abstain from alcohol for the duration of the study;
• Excessive daily consumption of tea, coffee, and/or caffeine-rich beverages for a prolonged period within 3 months prior to screening; or intake of xanthine/caffeine-containing or grapefruit-containing foods or beverages (e.g., coffee, strong tea, chocolate, grapefruit) within 24 hours prior to the first intravenous infusion;
• Using any prescription drugs, OTC medications (excluding hormonal contraceptives, topically applied eye/nose drops and creams with no systemic exposure risk), Chinese herbal medicines, or food supplements such as vitamins and calcium supplements within 14 days prior to screening or during the screening period, unless prior approval has been obtained from the Investigator and Sponsor;
• Using any drugs that inhibit or induce the activity of hepatic drug-metabolizing enzymes within 30 days prior to screening;
• History of a major surgical procedure within the past 6 months prior to screening, or planned elective surgery during the course of the study;
• Current or past history of psychiatric and/or , neurological diseases, and abnormalities of the motor or sensory systems, whether confirmed or suspected;
• Any clinically significant disease, or any clinically significant illness, condition, or other finding that, in the investigator's opinion, would pose a risk to subject safety or interfere with the conduct, progress, or completion of the study.;
• History or current using of hallucinations, which is viewed unsuitable for by investigator;
• History or current presence of psychiatric disorders and/or brain dysfunction;
• History of known or suspected hypersensitivity or allergic reaction to any component of the investigational product or to related compounds, drugs, or foods;
• Any other condition or reason that, in the opinion of the Investigator, would make the subject unsuitable for participation in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Mental Health Center (SMHC) — Шанхай

Идентификаторы

NCT: NCT07334249 · SP-CN_101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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