Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of QLS2319 in Healthy Subjects and Cancer Cachexia

Официальное название

A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLS2319 for Injection/Placebo Following Single-Dose Administration in Healthy Subjects and Multiple-Dose Administration in Subjects With Cancer Cachexia.

Обзор

Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of QLS2319 in Healthy Subjects and Cancer Cachexia

Подробное описание

This study is a first-in-human, dose-escalation trial in healthy adult participants and cancer cachexia to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of QLS2319.

The target population of dose escalation part is healthy adult participants, and the dose expansion part will enroll patients with cancer cachexia.

Вмешательства

• Препарат QLS2319
  QLS2319 will be administered via subcutaneous injection
• Препарат Placebo
  placebo will be administered via subcutaneous injection

Первичные конечные точки

• Phase Ia：Safety and tolerability after a single subcutaneous injection of QLS2319/placebo [Срок оценки: Up to Day 99]
• Phase Ib：Safety and tolerability after multiple subcutaneous injections of QLS2319 [Срок оценки: Up to 12 weeks]

Критерии участия

Критерии включения

Ia phase:

• Male and female subjects aged 18-55 years (inclusive), at the time of signing the ICF.;
• Body weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI = weight (kg)/height 2 (m) 2) of 18.5-26 kg/m2 (inclusive);
• Participants (including their partners) who have no plan to become pregnant and voluntarily use effective contraception from screening to 6 months after the last dose;

Ib phase:

• Subjects aged ≥ 18 years at screening;
• Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures;
• ECOG performance status score of 0, 1;
• Cancer cachexia documented in medical records; -

Критерии исключения

Ia phase:

• Subjects with clinically significant abnormal laboratory findings, or with clinically significant diseases or conditions, who are considered by the investigator to be ineligible for enrollment in this study.
• History of HIV infection, syphilis, hepatitis B, or hepatitis C;
• History of recurrent infections or active infections；
• Subjects who, in the judgment of the investigator, are not suitable for participation in the study.

Ib phase:

• Current active reversible causes of decreased food intake
• Cachexia caused by other reasons
• Receiving tube feedings or parenteral nutrition within 28 days prior to the first administration of the investigational product
• Presence of concomitant conditions, other than neoplastic cachexia, which are deemed by the investigator to cause difficulty in oral intake or malabsorption of ingested food.
• Subjects with known allergy to QLS2319 or any of its components, or with a history of severe allergic reactions or uncontrolled allergic asthma.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun-Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT07735104 · QLS2319-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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