Phase I Study of XTL6001 Injection in Healthy and Obese Subjects

Inclusion criteria

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.

Exclusion criteria

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.