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

NCT05917782 | Completed Phase 1

• 1 other identifier: CBP-201-CN004
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adult Subjects

Outcome Measures

Primary Outcomes (3)

• Cmax: Maximum concentration

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

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

• 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

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

• 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

  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)

• Maximum concentration (Cmax)

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

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

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

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

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

• Time to peak (Tmax)

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

• Elimination half-life (t1/2)

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

Study Arms (3)

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

EXPERIMENTAL

Strength: pre-filled syringe, 150 mg/1 mL

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)

EXPERIMENTAL

Strength: pre-filled syringe, 300 mg/2 mL

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 COMPARATOR

Strength: vial, 150 mg/1 mL

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

Interventions

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

subcutaneous injection of 2 doses on Day 1

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) BIOLOGICAL

subcutaneous injection of 1 dose on Day 1

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

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

subcutaneous injection of 2 doses on Day 1

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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:

Sponsors & Collaborators

• Connect Biopharm LLC: lead

Study Sites (1)

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

Location

MeSH Terms

Interventions

Drug Evaluation

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Officials

• Suzhou Connect

  Connect Biopharm LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: June 26, 2023
• Study Start: July 18, 2023
• Primary Completion: October 6, 2023
• Study Completion: October 6, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-10

Locations

CN (1)