A Randomized, Double-blind, Placebo-controlled, Dose Escalation, Phase I Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of CPX101 in Healthy Volunteers and Overweight or Obese Patients With Multiple Doses
This randomized, double-blind, placebo-controlled Phase I clinical study was designed to evaluate the tolerability and safety, PK profile, immunogenicity of CPX101 in a single dose in healthy participants and multiple doses in overweight and obese patients, and to initially explore the efficacy of multiple doses in weight loss. The study was divided into two parts: single administration and dose escalation (SAD) and multiple administration and dose escalation (MAD).
∙ SAD inclusion criteria:
• Healthy male or female participants aged 18 to 65 (inclusive) at the time of signing the informed consent form;
• When screening, body mass index (BMI)\>20 and\<28 kg/m2;
• During the entire study period, participants must agree to maintain stable dietary and physical activity habits, and have no plans to change their dietary or exercise habits or lose weight;
• Participants are able to understand and voluntarily sign a written Informed Consent Form (ICF), and are able to complete the relevant procedures and checks in accordance with the protocol;
• Female participants must meet the following conditions:
‣ No possibility of reproduction;
⁃ Possible fertility: The serum pregnancy test result was negative during screening, and effective contraceptive measures were agreed to be taken throughout the entire trial period and within 12 weeks after the last dose. Egg donation is not allowed within 12 weeks after the last dose;
• Male participants whose female partners have the potential to conceive must take effective contraceptive measures throughout the entire trial period and within 12 weeks after the last dose, and are not allowed to donate sperm.
∙ MAD inclusion criteria:
• Male or female participants aged 18 to 75 (inclusive) at the time of signing the informed consent form;
• When screening, obese individuals with 28 ≤ BMI\<40kg/m2, or overweight individuals with 24 ≤ BMI\<28kg/m2 and at least one of the following weight related comorbidities;
• During the first 3 months of screening, the weight remained stable;
• Willing to maintain a stable diet and exercise habits according to the research protocol throughout the entire study period;
• Participants are able to understand and voluntarily sign a written informed consent form (ICF), and are able to complete the relevant procedures and checks in accordance with the protocol;
• Female participants must meet the following conditions:
‣ No possibility of reproduction;
⁃ Possible fertility: The serum pregnancy test result was negative during screening, and effective contraceptive measures were agreed to be taken throughout the entire trial period and within 12 weeks after the last dose. Egg donation is not allowed within 12 weeks after the last dose;
• Male participants whose female partners have the potential to conceive must take effective contraceptive measures throughout the entire trial period and within 12 weeks after the last dose, and are not allowed to donate sperm.