Phase I Study of XTL6001 Injection in Healthy and Obese Subjects

Официальное название

A Randomized, Double-blind, Placebo-controlled Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Administration of XTL6001 Injection in Healthy and Obese Subjects

Обзор

This is a multicenter, randomized, double-blind, placebo-controlled Phase I study to evaluate safety, PK and PD of single ascending dose (SAD) and multiple ascending dose (MAD) of XTL6001 injection in healthy and obese adult subjects. SAD study: Includes 5 dose cohorts, with 40 subjects planned for enrollment. MAD study Includes 2 dose cohorts, with 30 subjects planned for enrollment.

Вмешательства

• Препарат XTL6001
  XTL6001 is a triple-target Glucagon-like peptide-1 receptor （GLP-1R） relevant agonist, intending to manage overweight/obesity and other metabolic diseases
• Препарат Placebo
  This intervention contains no active ingredients

Первичные конечные точки

• Incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events) [Срок оценки: SAD: up to Day 8 MAD: up to Day 57]

Вторичные конечные точки (12)

• The maximum plasma concentration (Cmax) of XTL6001 [Срок оценки: Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.]
• Tmax of XTL6001 [Срок оценки: Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.]
• Elimination half-life (T1/2) of XTL6001 [Срок оценки: Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.]
• Area under the plasma concentration-time curve during one dosing interval (AUC) 0-tau of XTL6001 [Срок оценки: Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.]
• AUC0-t of XTL6001 [Срок оценки: Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.]
• Body weight [Срок оценки: MAD: up to Day57]
• Body mass index （BMI） [Срок оценки: MAD: up to Day57]
• Waist circumference [Срок оценки: MAD: up to Day57]
• Waist-to-hip ratio [Срок оценки: MAD: up to Day57]
• Blood lipids [Срок оценки: MAD: up to Day57]
• Blood glucose [Срок оценки: MAD: up to Day57]
• Insulin [Срок оценки: MAD: up to Day57]

Критерии участия

Критерии включения

Inclusion Criteria for Subjects in SAD part:

• Age ≥ 18 and < 65 years at screening.
• Body mass index (BMI) ≥ 18.5 kg/m² and < 28.0 kg/m² at screening.
• Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening.
• Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions.

Inclusion Criteria for Subjects in MAD part:

• Age ≥ 18 and < 65 years at screening.
• BMI ≥ 18.5 kg/m2且 < 40.0kg/m².
• Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening.
• Stable body weight (fluctuation < 5%) for at least 3 months prior to screening.
• Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions.

Критерии исключения

Exclusion Criteria for Subjects in SAD part:

• History of type 1 or type 2 diabetes mellitus, or HbA1c > 6.5% or fasting plasma glucose > 7.0 mmol/L at screening.
• Clinically significant gastric emptying disorders, chronic use of medications directly affecting gastrointestinal motility, severe chronic gastrointestinal diseases, or prior gastrointestinal surgery.
• History of acute or chronic pancreatitis.
• Symptomatic gallbladder disease.
• Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer).
• Personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2A/2B (MEN 2A/2B).
• Female subjects with positive pregnancy test or lactation.

Exclusion Criteria for Subjects in MAD part:

• History of type 1 or type 2 diabetes mellitus, or HbA1c > 6.5% or fasting plasma glucose > 7.0 mmol/L at screening.
• UnderlyingCushing's syndrome, hypothyroidism, PCOS,.
• Clinically significant gastric emptying disorders, chronic use of medications directly affecting gastrointestinal motility, severe chronic gastrointestinal diseases, or gastrointestinal surgeries that may compromise safety or data interpretation.
• History of acute or chronic pancreatitis.
• Symptomatic gallbladder disease.
• Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer).
• Personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2A/2B (MEN 2A/2B).
• Female subjects with positive pregnancy test or lactation.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Shijitan Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT07205432 · XTL6001-I-C01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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