AzTrials
AzTrials

Healthy Adult SubjectsPhase 1NCT05917782

A Study to Evaluate the Pharmacokinetics Similarity of CBP-201 in Healthy Adult Chinese Subjects

A Phase 1 study testing Test drug (T1): CBP-201 injection (pre-filled syringe, 150 mg/1 mL), Test drug (T2): CBP-201 injection (pre-filled syringe, 300 mg/2 mL) and Reference drug (R): CBP-201 injection (vial, 150 mg/1 mL) in people with Healthy Adult Subjects, run by Connect Biopharm LLC at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-center, randomized, open-label, single-dose, parallel-designed PK similarity study. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Adult Subjects
What is being tested?
Test drug (T1): CBP-201 injection (pre-filled syringe, 150 mg/1 mL), Test drug (T2): CBP-201 injection (pre-filled syringe, 300 mg/2 mL) and Reference drug (R): CBP-201 injection (vial, 150 mg/1 mL)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
324 participants
Where
1 siteChina
Study dates
18 Jul 2023to 6 Oct 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects who are to read, understand, and sign the ICF.
  • 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.
  • Body mass index (BMI) is between 19 and 28 kg/m2 (inclusive). Male subjects weigh ≥ 50 kg, and female subjects weigh ≥ 45 kg.
  • 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.
  • 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.
  • Subjects who are able to communicate well with the clinical staff and complete the study according to the protocol.

Who cannot join

  • 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.
  • 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.
  • Subjects who have donated blood or have had substantial loss of blood (> 400 mL) within 3 months before administration.
  • Subjects who have been vaccinated with live (attenuated) vaccines within 3 months before administration.
  • Subjects who have participated in clinical studies of other drugs within 3 months before administration.
  • 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.
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  • 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.
  • Female subjects who test positive for pregnancy at screening or baseline or who are lactating.
  • Subjects who smoke more than 5 cigarettes or equivalent per day within 3 months before administration.
  • 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.
  • 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.
  • Subjects with known symptoms of dermatitis or skin abnormalities at and around the site of administration.
  • 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).
  • 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.
  • Subjects with white blood cell count and neutrophil count below the lower limit of normal.
  • Female subjects with hemoglobin values less than 110 g/L or male subjects less than 120 g/L.
  • Subjects who cannot tolerate venous blood sampling, or who have a history of acupuncture syncope or hemophobia.
  • Subjects who still need or plan to engage in strenuous physical activity or exercise during the study.
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230000

Other trials in China

About this study

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

This is a single-center, randomized, open-label, single-dose, parallel-designed PK similarity study.

Read the detailed description

A total of 324 healthy subjects are planned to be enrolled and randomized into 3 groups at a ratio of 1:1:1, with 108 subjects in each group. They will receive 2 doses of the test drug T1 (CBP-201 injection (pre-filled syringe, 150 mg/1 mL)), 1 dose of the test drug T2 (CBP-201 injection (pre-filled syringe, 300 mg/2 mL)), and 2 doses of the reference drug R (CBP-201 injection (vial, 150 mg/1 mL)), respectively.

The study consists of a screening period (Day-28 to Day-2), a baseline period (Day-1), an administration and observation period (Day1 to Day6), and a follow-up period (Day7 to Day57).

Being tested
Test drug (T1): CBP-201 injection (pre-filled syringe, 150 mg/1 mL), Test drug (T2): CBP-201 injection (pre-filled syringe, 300 mg/2 mL), Reference drug (R): CBP-201 injection (vial, 150 mg/1 mL)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Test drug (T1): CBP-201 injection (pre-filled syringe, 150 mg/1 mL)Biological

    subcutaneous injection of 2 doses on Day 1

  • Test drug (T2): CBP-201 injection (pre-filled syringe, 300 mg/2 mL)Biological

    subcutaneous injection of 1 dose on Day 1

  • Reference drug (R): CBP-201 injection (vial, 150 mg/1 mL)Biological

    subcutaneous injection of 2 doses on Day 1

Study groups in NCT05917782
Study groupRoleWhat they receive
Test drug (T1): CBP-201 injection (pre-filled syringe, 150 mg/1 mL)ExperimentalStrength: pre-filled syringe, 150 mg/1 mL
Receives: Biological: Test drug (T1): CBP-201 injection (pre-filled syringe, 150 mg/1 mL)
Test drug (T2): CBP-201 injection (pre-filled syringe, 300 mg/2 mL)ExperimentalStrength: pre-filled syringe, 300 mg/2 mL
Receives: Biological: Test drug (T2): CBP-201 injection (pre-filled syringe, 300 mg/2 mL)
Reference drug (R): CBP-201 injection (vial, 150 mg/1 mL)Active comparatorStrength: vial, 150 mg/1 mL
Receives: Biological: Reference drug (R): CBP-201 injection (vial, 150 mg/1 mL)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax: Maximum concentration

    Pharmacokinetics similarity evaluation for test drug T1, test drug T2 and reference drug R

    Measured: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose

  2. AUC0-t: Area under the plasma concentration-time curve from the start of administration to the last measurable concentration time point T

    Pharmacokinetics similarity evaluation for test drug T1, test drug T2 and reference drug R

    Measured: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose

  3. AUC0-inf: Area under the plasma concentration-time curve from the start of administration to infinity

    Pharmacokinetics similarity evaluation for test drug T1, test drug T2 and reference drug R

    Measured: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose

Secondary outcomes (67)

  1. Maximum concentration (Cmax)

    Calculated by non-compartmental analysis (NCA) using WinNonLin V8.3.1 (or higher version)

    Measured: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose

  2. Area under the plasma concentration-time curve from the start of administration to the last measurable concentration time point T (AUC0-t)

    Calculated by non-compartmental analysis (NCA) using WinNonLin V8.3.1 (or higher version)

    Measured: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose

  3. Area under the plasma concentration-time curve from the start of administration to infinity (AUC0-inf)

    Calculated by non-compartmental analysis (NCA) using WinNonLin V8.3.1 (or higher version)

    Measured: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose

  4. Time to peak (Tmax)

    Calculated by non-compartmental analysis (NCA) using WinNonLin V8.3.1 (or higher version)

    Measured: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose

  5. Elimination half-life (t1/2)

    Calculated by non-compartmental analysis (NCA) using WinNonLin V8.3.1 (or higher version)

    Measured: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose

  6. Apparent clearance (CL/F)

    Calculated by non-compartmental analysis (NCA) using WinNonLin V8.3.1 (or higher version)

    Measured: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose

  7. Apparent volume of distribution (Vz/F)

    Calculated by non-compartmental analysis (NCA) using WinNonLin V8.3.1 (or higher version)

    Measured: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose

  8. Terminal elimination phase rate constant (λz)

    Calculated by non-compartmental analysis (NCA) using WinNonLin V8.3.1 (or higher version)

    Measured: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose

  9. Adverse events (AEs)

    All adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA) (the latest version).

    Measured: Up to 57 days post dosing

  10. Injection site reactions

    The injection site will be examined and the results will be judged by the investigator.

    Measured: Day1, Day2, Day3, Day4, Day6, Day8, Day15, Day22, Day29, Day57

  11. Blood Pressure (systolic and diastolic blood pressures)

    The results as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day1, Day2, Day3, Day4, Day6, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57

  12. Pulse

    The results as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day1, Day2, Day3, Day4, Day6, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57

  13. Body Temperature (ear temperature)

    The results as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day1, Day2, Day3, Day4, Day6, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57

  14. Respiratory Rate

    The results as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day1, Day2, Day3, Day4, Day6, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57

  15. Physical examination

    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.

    Measured: pre-dose, Day6, Day15, Day29, Day57

  16. 12-lead electrocardiogram (ECG)

    ECG variables include ventricular heart rate, PR interval, QRS interval, QT interval, and QTcF interval.

    Measured: pre-dose, Day1, Day2, Day4, Day6, Day10, Day15, Day22, Day29, Day36, Day43, Day57

  17. Clinical laboratory test: Hematology - Hemoglobin (Hgb)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  18. Clinical laboratory test: Hematology - Hematocrit (Hct)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  19. Clinical laboratory test: Hematology - red blood cell count (RBC)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  20. Clinical laboratory test: Hematology - platelet count

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  21. Clinical laboratory test: Hematology - white blood cell count (WBC)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  22. Clinical laboratory test: Hematology - lymphocyte count

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  23. Clinical laboratory test: Hematology - lymphocyte percentage

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  24. Clinical laboratory test: Hematology - neutrophil count

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  25. Clinical laboratory test: Hematology - neutrophil percentage

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  26. Clinical laboratory test: Hematology - monocyte count

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  27. Clinical laboratory test: Hematology - monocyte percentage

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  28. Clinical laboratory test: Hematology - eosinophil count

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  29. Clinical laboratory test: Hematology - eosinophil percentage

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  30. Clinical laboratory test: Hematology - basophil count

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  31. Clinical laboratory test: Hematology - basophil percentage

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  32. Clinical laboratory test: Hematology - mean corpuscular hemoglobin (MCH)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  33. Clinical laboratory test: Hematology - mean corpuscular volume (MCV)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  34. Clinical laboratory test: Urinalysis

    Urine protein, cast, urine red blood cells, urine white blood cells, urine pH, urine ketone body, glucose urine, urine bilirubin, and urine occult blood

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  35. Clinical laboratory test: Biochemistry - Glucose (Glu)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  36. Clinical laboratory test: Biochemistry - alanine aminotransferase (ALT)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  37. Clinical laboratory test: Biochemistry - aspartate aminotransferase (AST)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  38. Clinical laboratory test: Biochemistry - alkaline phosphatase (ALP)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  39. Clinical laboratory test: Biochemistry - lactate dehydrogenase (LDH)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  40. Clinical laboratory test: Biochemistry - gamma-glutamyltransferase (γ-GGT)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  41. Clinical laboratory test: Biochemistry - serum total protein (TP)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  42. Clinical laboratory test: Biochemistry - albumin (ALB)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  43. Clinical laboratory test: Biochemistry - total bilirubin (TBIL)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  44. Clinical laboratory test: Biochemistry - direct bilirubin (DBIL)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  45. Clinical laboratory test: Biochemistry - blood urea nitrogen (BUN)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  46. Clinical laboratory test: Biochemistry - creatinine (Crea)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  47. Clinical laboratory test: Biochemistry - sodium (Na)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  48. Clinical laboratory test: Biochemistry - potassium (K)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  49. Clinical laboratory test: Biochemistry - chlorine (Cl)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  50. Clinical laboratory test: Biochemistry - calcium (Ca)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  51. Clinical laboratory test: Biochemistry - phosphorus (P)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  52. Clinical laboratory test: Biochemistry - triglycerides (TG)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  53. Clinical laboratory test: Biochemistry - total cholesterol (TC)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  54. Clinical laboratory test: Biochemistry - high-density lipoprotein cholesterol (HDL-C)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  55. Clinical laboratory test: Biochemistry - low-density lipoprotein cholesterol (LDL-C)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  56. Clinical laboratory test: Biochemistry - uric acid (UA)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  57. Clinical laboratory test: Biochemistry - creatine kinase (CK)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  58. Clinical laboratory test: Coagulation - International normalized ratio (INR)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  59. Clinical laboratory test: Coagulation - prothrombin time (PT)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  60. Clinical laboratory test: Coagulation - activated partial thromboplastin time (APTT)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  61. Clinical laboratory test: Coagulation - fibrinogen (FIB)

    The results of clinical laboratory tests, as well as their changes from baseline will be statistically summarized by dose group and visit.

    Measured: pre-dose, Day6, Day15, Day29, Day43, Day57

  62. Clinical laboratory test: Pregnancy test

    Blood pregnancy test (for females only)

    Measured: pre-dose, Day15, Day29, Day43, Day57

  63. Clinical laboratory test: Infectious serology

    Hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, Treponema pallidum antibody, and human immunodeficiency virus antibody

    Measured: pre-dose

  64. Clinical laboratory test: Blood alcohol test

    Blood alcohol test

    Measured: pre-dose

  65. Clinical laboratory test: Urine drug abuse screening

    Morphine, methamphetamine, ketamine, methylenedioxy methylamphetamine, marijuana, and cocaine

    Measured: pre-dose

  66. T-Spot

    If necessary, T-spot screening can be performed for priorly infected or suspected patients

    Measured: pre-dose

  67. Immunogenicity: The positive rate and titer of anti-drug antibody (ADA), and the positive rate of neutralizing antibody (Nab, in case of ADA positive results)

    Immunogenicity will be analyzed based on IMS. The number and percentage of subjects positive for CBP-201 ADA and Nab will be summarized by dose group.

    Measured: pre-dose, Day11, Day29, Day43, Day57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2023
  2. Study start18 Jul 2023
  3. Primary completion6 Oct 2023
  4. Study completion6 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
324 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05917782
Sponsor's protocol ID
CBP-201-CN004
Status last verified
Oct 2023
First submitted
4 Jun 2023
Last updated
31 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Test drug (T1): CBP-201 injection (pre-filled syringe, 150 mg/1 mL), Test drug (T2): CBP-201 injection (pre-filled syringe, 300 mg/2 mL) and Reference drug (R): CBP-201 injection (vial, 150 mg/1 mL) in people with Healthy Adult Subjects, run by Connect Biopharm LLC at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax: Maximum concentration (time frame: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05917782.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.

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