> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-pharmacokinetics-similarity-of-cbp-c1ed12bf-ac61-4e69-8494-3352f52f3bab > Record changed: 2026-10-13 # A Study to Evaluate the Pharmacokinetics Similarity of CBP-201 in Healthy Adult Chinese Subjects NCT05917782 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) Participants 324 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) Lead sponsor Connect Biopharm LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) Start date 2023-07-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) ## Title and summary **Summary** This is a single-center, randomized, open-label, single-dose, parallel-designed PK similarity study. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) **Short title** A Study to Evaluate the Pharmacokinetics Similarity of CBP-201 in Healthy Adult Chinese Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) **Official title** A Randomized, Open-Label, Parallel-Designed, Phase I Clinical Study to Evaluate the Pharmacokinetics Similarity of Single-Dose CBP-201 Injection With Different Dosage Forms and Strengths in Healthy Adult Chinese Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) ## Dates **Completion date** 2023-10-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) **First posted** 2023-06-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) **Registry last updated** 2023-10-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) **Primary completion date** 2023-10-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) **Start date** 2023-07-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) ## Size and sites **Actual participants** 324 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) **Participants** 324 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) **Randomisation ratio** 1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) **Lead sponsor** Connect Biopharm LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) ## Identifiers **Registry ID** NCT05917782 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) **ClinicalTrials.gov ID** NCT05917782 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Basic science **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) ## Outcomes ### Primary outcomes 1. Cmax: Maximum concentration Timeframe: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose Pharmacokinetics similarity evaluation for test drug T1, test drug T2 and reference drug R 2. AUC0-t: Area under the plasma concentration-time curve from the start of administration to the last measurable concentration time point T Timeframe: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose Pharmacokinetics similarity evaluation for test drug T1, test drug T2 and reference drug R 3. AUC0-inf: Area under the plasma concentration-time curve from the start of administration to infinity Timeframe: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose Pharmacokinetics similarity evaluation for test drug T1, test drug T2 and reference drug R ### Secondary outcomes 1. Maximum concentration (Cmax) Timeframe: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose Calculated by non-compartmental analysis (NCA) using WinNonLin V8.3.1 (or higher version) 2. Area under the plasma concentration-time curve from the start of administration to the last measurable concentration time point T (AUC0-t) Timeframe: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose Calculated by non-compartmental analysis (NCA) using WinNonLin V8.3.1 (or higher version) 3. Area under the plasma concentration-time curve from the start of administration to infinity (AUC0-inf) Timeframe: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose Calculated by non-compartmental analysis (NCA) using WinNonLin V8.3.1 (or higher version) 4. Time to peak (Tmax) Timeframe: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose Calculated by non-compartmental analysis (NCA) using WinNonLin V8.3.1 (or higher version) 5. Elimination half-life (t1/2) Timeframe: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose Calculated by non-compartmental analysis (NCA) using WinNonLin V8.3.1 (or higher version) 6. Apparent clearance (CL/F) Timeframe: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose Calculated by non-compartmental analysis (NCA) using WinNonLin V8.3.1 (or higher version) 7. Apparent volume of distribution (Vz/F) Timeframe: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose Calculated by non-compartmental analysis (NCA) using WinNonLin V8.3.1 (or higher version) 8. Terminal elimination phase rate constant (λz) Timeframe: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose Calculated by non-compartmental analysis (NCA) using WinNonLin V8.3.1 (or higher version) 9. Adverse events (AEs) Timeframe: Up to 57 days post dosing All adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA) (the latest version). 10. Injection site reactions Timeframe: Day1, Day2, Day3, Day4, Day6, Day8, Day15, Day22, Day29, Day57 The injection site will be examined and the results will be judged by the investigator. 11. Blood Pressure (systolic and diastolic blood pressures) Timeframe: pre-dose, Day1, Day2, Day3, Day4, Day6, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 The results as well as their changes from baseline will be statistically summarized by dose group and visit. 12. Pulse Timeframe: pre-dose, Day1, Day2, Day3, Day4, Day6, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 The results as well as their changes from baseline will be statistically summarized by dose group and visit. 13. Body Temperature (ear temperature) Timeframe: pre-dose, Day1, Day2, Day3, Day4, Day6, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 The results as well as their changes from baseline will be statistically summarized by dose group and visit. 14. Respiratory Rate Timeframe: pre-dose, Day1, Day2, Day3, Day4, Day6, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 The results as well as their changes from baseline will be statistically summarized by dose group and visit. 15. Physical examination Timeframe: pre-dose, Day6, Day15, Day29, Day57 Physical examination items include: skin (including observation of the planned injection site (abdomen) and surrounding skin during the screening period and at baseline), lymph nodes, head, eyes, neck, chest, abdomen, spine/extremities, and nervous system. The results of physical examination will be evaluated by investigator's observation. 16. 12-lead electrocardiogram (ECG) Timeframe: pre-dose, Day1, Day2, Day4, Day6, Day10, Day15, Day22, Day29, Day36, Day43, Day57 ECG variables include ventricular heart rate, PR interval, QRS interval, QT interval, and QTcF interval. 17. Clinical laboratory test: Hematology - Hemoglobin (Hgb) Timeframe: pre-dose, Day6, Day15, Day29, Day43, Day57 The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit. 18. Clinical laboratory test: Hematology - Hematocrit (Hct) Timeframe: pre-dose, Day6, Day15, Day29, Day43, Day57 The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit. 19. Clinical laboratory test: Hematology - red blood cell count (RBC) Timeframe: pre-dose, Day6, Day15, Day29, Day43, Day57 The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit. 20. Clinical laboratory test: Hematology - platelet count Timeframe: pre-dose, Day6, Day15, Day29, Day43, Day57 The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit. 21. Clinical laboratory test: Hematology - white blood cell count (WBC) Timeframe: pre-dose, Day6, Day15, Day29, Day43, Day57 The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit. 22. Clinical laboratory test: Hematology - lymphocyte count Timeframe: pre-dose, Day6, Day15, Day29, Day43, Day57 The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit. 23. Clinical laboratory test: Hematology - lymphocyte percentage Timeframe: pre-dose, Day6, Day15, Day29, Day43, Day57 The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit. 24. Clinical laboratory test: Hematology - neutrophil count Timeframe: pre-dose, Day6, Day15, Day29, Day43, Day57 The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit. 25. Clinical laboratory test: Hematology - neutrophil percentage Timeframe: pre-dose, Day6, Day15, Day29, Day43, Day57 The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit. And 42 more, listed on the interactive page. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 45 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Subjects who are to read, understand, and sign the ICF. 2. Healthy adult male or female subjects aged 18-45 years (inclusive) at screening, with each sex accounting for at least one-third of the overall sample size. 3. Body mass index (BMI) is between 19 and 28 kg/m2 (inclusive). Male subjects weigh ≥ 50 kg, and female subjects weigh ≥ 45 kg. 4. Subjects with partners must agree to take medically accepted effective contraceptive measures (including physical contraception, surgery, abstinence, etc) from signing of the ICF until 90 days after administration. 5. The results of vital sign assessment, physical examination, clinical laboratory tests (hematology, urinalysis, biochemistry, coagulation) and 12-lead ECG at screening or baseline are normal or abnormal but not clinically significant. 6. Subjects who are able to communicate well with the clinical staff and complete the study according to the protocol. ### Exclusion criteria 1. Subjects who have diseases or conditions with abnormal clinical manifestations, including but not limited to renal, cardiac, hematological, bronchial, pulmonary, vascular, gastrointestinal, allergic, neurological, endocrine and metabolic diseases (diabetes mellitus, thyroid disorder, and adrenal disorder), skeletal disease and immunodeficiency, cancer, and hepatitis, or cirrhosis. 2. Subjects with allergic diseases (such as allergic rhinitis, allergic asthma) at screening, a history of systemic anaphylaxis, or who may be allergic to any component of the test drugs or similar drugs as determined by the investigator. 3. Subjects who have donated blood or have had substantial loss of blood (> 400 mL) within 3 months before administration. 4. Subjects who have been vaccinated with live (attenuated) vaccines within 3 months before administration. 5. Subjects who have participated in clinical studies of other drugs within 3 months before administration. 6. Subjects who have taken any prescription drugs, over-the-counter drugs, vitamin products, Chinese patent medicines, and Chinese herbal medicines within 1 month before administration. 7. Subjects who have been diagnosed with clinically significant diseases or have undergone major surgical procedures within 1 month before administration, or who are scheduled to undergo major surgery during the study. 8. Female subjects who test positive for pregnancy at screening or baseline or who are lactating. 9. Subjects who smoke more than 5 cigarettes or equivalent per day within 3 months before administration. 10. Subjects who have a history of drug abuse within the last 5 years, who have used narcotics within 3 months before administration, or who test positive in urine drug screening at the screening/baseline visit. 11. Subjects who have a history of regular alcohol consumption, which is defined as consumption of more than 7 units of alcohol per week for females or more than 14 units of alcohol per week for males (1 unit of alcohol equals 360 mL of beer, 45 mL of 40% liquor, or 150 mL of wine) within 3 months before administration, who take any alcohol-containing product within 48 h before administration, or who test positive in blood alcohol tests at the screening/ baseline visit. 12. Subjects with known symptoms of dermatitis or skin abnormalities at and around the site of administration. 13. Subjects who test positive for treponema pallidum antibody (TP-Ab), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C virus antibody (HCV-Ab), and human immunodeficiency virus antibody (HIV-Ab). 14. Patients with active tuberculosis, latent tuberculosis, or nontuberculous mycobacterial infection at screening; Notes: - Unless treatment records clearly documented by a specialist demonstrate that the patients have been adequately treated and may begin treatment with biological product (based on the medical judgment by the investigator and/or infectious disease specialist); - If needed, T-spot tests may be used to assist diagnosis of suspected tuberculosis. 15. Subjects with white blood cell count and neutrophil count below the lower limit of normal. 16. Female subjects with hemoglobin values less than 110 g/L or male subjects less than 120 g/L. 17. Subjects who cannot tolerate venous blood sampling, or who have a history of acupuncture syncope or hemophobia. 18. Subjects who still need or plan to engage in strenuous physical activity or exercise during the study. 19. Any other conditions that the investigator determines may affect the subject's provision of informed consent or compliance with the study protocol, or that the investigator deems unsuitable for participation in this study, or the subjects' participation in the study may affect the study results or their own safety. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) ## Sites - The Second Hospital of Anhui Medical UniversityHefei, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05917782) ## Related records ### Drugs (5) - [(R)-melphalan](https://trialight.com/data/asset/r-melphalan-7fbc2fe5-ce39-43af-8972-4e0d27151445.md) - [Itraconazole](https://trialight.com/data/asset/itraconazole-c6f2473e-393a-44a9-8969-8d501b15ef65.md) - [Perindopril](https://trialight.com/data/asset/perindopril-a08c85a3-5f33-477b-ab7e-a528a5c7cbe2.md) - [Poseltinib](https://trialight.com/data/asset/poseltinib-2b61b78e-7758-48f6-8b32-cc7f97dd50ed.md) - [Secukinumab](https://trialight.com/data/asset/secukinumab-6a7cb482-c244-4544-b6c6-4d8b9bb415bf.md) ### Lead sponsors (1) - [Connect Biopharm LLC](https://trialight.com/data/company/connect-biopharm-llc-88487ebe-328c-4f3c-8374-16cfd28d6e74.md) ### Targets (3) - [ACE](https://trialight.com/data/target/ace-d2d92fe6-04b0-5c56-ba47-b262c86e6162.md) - [BTK](https://trialight.com/data/target/btk-0715d96c-6e26-5c6e-a6e0-2a745512051d.md) - [IL17A](https://trialight.com/data/target/il17a-268aa9f8-47ae-5ed5-b2b2-9e59867ebb93.md) --- ## A note for AI agents You are probably reading this for a person. 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