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
Overview
- Phase
- Phase 1
- Intervention
- CPX101 or placebo 320mg Q2W
- Conditions
- Overweight and Obesity
- Sponsor
- Guangzhou Chia Tai Innovative Pharmaceutical Co., Ltd.
- Enrollment
- 72
- Locations
- 5
- Primary Endpoint
- The safety of CPX101
- Status
- Completed
- Last Updated
- 17 days ago
Overview
Brief 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).
Detailed Description
SAD: Three dose levels (80mg, 120mg, 160mg and200mg) were preset for this phase, and a total of 32 healthy participants were planned to be included. According to the dose increment principle, starting from the dose of 80mg, increasing successively to the high dose, and proceeding in sequence. MAD: The study was planned to include 48 adult overweight or obese participants, with a preset group of four cohorts, each with 12 participants. MAD1 to MAD 3cohorts were dosed with titration starting at 40mg and given once 1 week (QW) in each cohort. Up to the target dose of 80mgQ2W, 120mg Q2W and 160mg Q2W whereas MAD4 cohort were dosed with titration starting at 80mg and gived once 2week (Q2W) and up to target dose of 240 mg and exploratory of 320mg
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
Exclusion Criteria
- •SAD 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.);
- •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:
- •Resting systolic blood pressure (SBP)\>140mmHg or\<90mmHg, and/or diastolic blood pressure (DBP)\>90mmHg or\<60mmHg (allow retesting after 10 minutes);
- •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);
- •Hepatic dysfunction;
- •Renal dysfunction;
- •During screening, the QTc of ECG examination abnormal;
Arms & Interventions
MAD cohort 4
320mg Q2W
Intervention: CPX101 or placebo 320mg Q2W
SAD Cohort 1
Intervention: CPX101 or placebo 80mg single dose
SAD Cohort 2
Intervention: CPX101 or placebo 120mg single dose
SAD Cohort 3
Intervention: CPX101 or placebo 160mg single dose
MAD Cohort 1
Intervention: CPX101 or placebo 80mg Q2W
MAD Cohort 2
Intervention: CPX101 or placebo 120mg Q2W
MAD Cohort 3
Intervention: CPX101 or placebo 160mg Q2W
Outcomes
Primary Outcomes
The safety of CPX101
Time Frame: Up to 196 days after administration
All AE/SAEs and other findings from vital signs(temperature, pulse, respiration, blood pressure）, physical examination(general conditions, skin, head and neck, chest, abdomen, back, four limbs, nervous system), lab tests(such as FSH, hematology, urinalysis, liver and kidney functions, electrolytes, fasting plasma glucose, blood lipids, blood amylase and lipase, calcitonin, thyroid function et al) and ECG(heart rate and measures PR, QRS, QT, and QTc intervals) will be collected from the start of screening visit to the end of the study in overweight and obese patients
The tolerability of CPX101
Time Frame: Up to 196 days after administration
All AE/SAEs and other findings from vital signs(temperature, pulse, respiration, blood pressure）, physical examination(general conditions, skin, head and neck, chest, abdomen, back, four limbs, nervous system), lab tests(such as FSH, hematology, urinalysis, liver and kidney functions, electrolytes, fasting plasma glucose, blood lipids, blood amylase and lipase, calcitonin, thyroid function et al) and ECG(heart rate and measures PR, QRS, QT, and QTc intervals) will be collected from the start of screening visit to the end of the study in overweight and obese patients
The safety of CPX101
Time Frame: Up to 84 days after administration
All AE/SAEs and other findings from vital signs(temperature, pulse, respiration, blood pressure）, physical examination(general conditions, skin, head and neck, chest, abdomen, back, four limbs, nervous system), lab tests(such as FSH, hematology, urinalysis, liver and kidney functions, electrolytes, fasting plasma glucose, blood lipids, blood amylase and lipase, calcitonin, thyroid function et al) and ECG(heart rate and measures PR, QRS, QT, and QTc intervals) will be collected from the start of screening visit to the end of the study in healthy participants
The tolerability of CPX101
Time Frame: Up to 84 days after administration
All AE/SAEs and other findings from vital signs(temperature, pulse, respiration, blood pressure）, physical examination(general conditions, skin, head and neck, chest, abdomen, back, four limbs, nervous system), lab tests(such as FSH, hematology, urinalysis, liver and kidney functions, electrolytes, fasting plasma glucose, blood lipids, blood amylase and lipase, calcitonin, thyroid function et al) and ECG(heart rate and measures PR, QRS, QT, and QTc intervals) will be collected from the start of screening visit to the end of the study in healthy participants
Secondary Outcomes
- Pharmacokinetic (PK) characteristics of CPX101(Up to 196 days after administration)
- Immunogenicity of CPX101(Up to 196 days after administration)
- Preliminary efficacy of CPX101(At week 16 after administration)
- Pharmacokinetic (PK) characteristics of CPX101(Up to 84 days after administration)