Safety, Tolerability, and Pharmacokinetics of a Single or Multiple Ascending Doses of CPX101
NCT Number: NCT06545162
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Overweight and Obesity
Interventions: BIOLOGICAL: CPX101 or placebo 80mg single dose|BIOLOGICAL: CPX101 or placebo 120mg single dose|BIOLOGICAL: CPX101 or placebo 160mg single dose|BIOLOGICAL: CPX101 or placebo 80mg Q2W|BIOLOGICAL: CPX101 or placebo 120mg Q2W|BIOLOGICAL: CPX101 or placebo 160mg Q2W|BIOLOGICAL: CPX101 or placebo 200mg Q2W
Sponsor: Guangzhou Chia Tai Innovative Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-12

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).

Primary Outcome Measures: The safety of CPX101, 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, Up to 84 days after administration|The tolerability of CPX101, 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, Up to 84 days after administration|The safety of CPX101, 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, Up to 196 days after administration|The tolerability of CPX101, 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, Up to 196 days after administration
Secondary Outcome Measures: Pharmacokinetic (PK) characteristics of CPX101, Measurement of the concentration of CPX101 in serum after single dose injection in healthy participants, Up to 84 days after administration|Preliminary efficacy of CPX101, Evaluate the preliminary efficacy parameters (including body weight loss, waist circumference, BMI et al.) of multiple administration of CPX101 in overweight and obese patients. 1) body weight record the value in kilograms. 2) waist and hip circumference record the value in cm, Waist-to-hip ratio = waist circumference/hip circumference. 3) BMI = weight (kg) / (height \[m\])\^2., At week 16 after administration|Pharmacokinetic (PK) characteristics of CPX101, Measurement of the concentration of CPX101 in serum after multiple administration of CPX101 in overweight and obese patients, Up to 196 days after administration|Immunogenicity of CPX101, Measurement of the anti-CPX101 antibody in serum after multiple administrations in overweight and obese patients, Up to 196 days after administration