About this trial
• To assess the safety of multiple oral doses of HDM1002 tablets under different titrations in Chinese overweight and obese adult subjects.
Eligibility criteria
Qualifiers
Chinese subjects aged 18 to 60 years (including 18 years and 60 years old), either male or female subjects;
BMI at 24.0 to 36.0 kg at screening and at random / m2Between (including 24.0 and 36.0 kg / m2);
For fertile subjects, female subjects from 14 days before the informed consent form (ICF) to 30 days after the last administration, male subjects within 90 days after the ICF to the last administration, without birth planning and agreed to highly effective contraception (see Section 5.2.3 for details);
Ability to understand the procedures and methods of this study, voluntarily sign the ICF, and be willing to strictly comply with the clinical trial protocol requirements to complete the relevant process.
Disqualifiers
Chinese subjects aged 18 to 60 years (including 18 years and 60 years old), either male or female subjects;
BMI at 24.0 to 36.0 kg at screening and at random / m2Between (including 24.0 and 36.0 kg / m2);
For fertile subjects, female subjects from 14 days before the informed consent form (ICF) to 30 days after the last administration, male subjects within 90 days after the ICF to the last administration, without birth planning and agreed to highly effective contraception (see Section 5.2.3 for details);
Ability to understand the procedures and methods of this study, voluntarily sign the ICF, and be willing to strictly comply with the clinical trial protocol requirements to complete the relevant process.
Trial design
Treatments tested in this trial
- HDM1002 100 mg QD 12weeks
- HDM1002 200 mg QD 12weeks
- HDM1002 400 mg QD 12weeks,Q 2W for titration
- HDM1002 400 mg QD 12weeks,Q 3W for titration
- Placebo