Phase I Study of XTL6001 Injection in Healthy and Obese Subjects
Recruiting · NCT07205432 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboXTL6001
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Beijing Shijitan Hospital, Capital Medical University - Beijing, Beijing Municipality, China