Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT07205432
Eligibility Criteria:
Inclusion Criteria:
Inclusion Criteria for Subjects in SAD part:
1. Age ≥ 18 and \< 65 years at screening.
2. Body mass index (BMI) ≥ 18.5 kg/m² and \< 28.0 kg/m² at screening.
3. Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening.
4. 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:
1. Age ≥ 18 and \< 65 years at screening.
2. BMI ≥ 18.5 kg/m2且 \< 40.0kg/m².
3. Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening.
4. Stable body weight (fluctuation \< 5%) for at least 3 months prior to screening.
5. 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:
1. History of type 1 or type 2 diabetes mellitus, or HbA1c \> 6.5% or fasting plasma glucose \> 7.0 mmol/L at screening.
2. Clinically significant gastric emptying disorders, chronic use of medications directly affecting gastrointestinal motility, severe chronic gastrointestinal diseases, or prior gastrointestinal surgery.
3. History of acute or chronic pancreatitis.
4. Symptomatic gallbladder disease.
5. Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer).
6. Personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2A/2B (MEN 2A/2B).
7. Female subjects with positive pregnancy test or lactation.
Exclusion Criteria for Subjects in MAD part:
1. History of type 1 or type 2 diabetes mellitus, or HbA1c \> 6.5% or fasting plasma glucose \> 7.0 mmol/L at screening.
2. UnderlyingCushing's syndrome, hypothyroidism, PCOS,.
3. 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.
4. History of acute or chronic pancreatitis.
5. Symptomatic gallbladder disease.
6. Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer).
7. Personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2A/2B (MEN 2A/2B).
8. Female subjects with positive pregnancy test or lactation.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07205432
Study Brief:
Protocol Section:
NCT07205432