Safety, Tolerability, and Pharmacokinetics of a Single or Multiple Ascending Doses of CPX101 (NCT06545162) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability, and Pharmacokinetics of a Single or Multiple Ascending Doses of CPX101
China72 participantsStarted 2024-12-04
Plain-language summary
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).
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
Exclusion criteria
✕. When screening, if there is a medical history or clinical evidence showing that participants have obvious accompanying diseases (including but not limited to cardiovascular, respiratory, digestive, urinary, neurological/psychiatric, blood, immune, endocrine and metabolic, infection, etc.);
What they're measuring
1
The safety of CPX101
Timeframe: Up to 84 days after administration
2
The tolerability of CPX101
Timeframe: Up to 84 days after administration
3
The safety of CPX101
Timeframe: Up to 196 days after administration
4
The tolerability of CPX101
Timeframe: Up to 196 days after administration
Trial details
NCT IDNCT06545162
SponsorGuangzhou Chia Tai Innovative Pharmaceutical Co., Ltd.
✕. During the screening period, acute diseases with clinical significance (such as gastrointestinal diseases, gallbladder diseases, pancreatitis), infections (such as influenza, upper respiratory tract infections), which are judged by the investigator to be not suitable for participants in the trial;
✕. Use any prescription medication (excluding hormonal contraceptives), over-the-counter medication, herbal medicine, or health supplement within the first 30 days of randomization;
✕. When screening, the physical examination or laboratory test results meet any of the following criteria:
✕. When screening, the heart rate should be greater than 100 beats per minute or less than 50 beats per minute (allowing for retesting after 10 minutes);