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

October 29, 2023 updated by: Suzhou Connect Biopharmaceuticals, Ltd.

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.

Study Overview

Status

Completed

Conditions

Healthy Adult Subjects

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

324

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Tian Zhang
Phone Number: (+86)0512-53577866
Email: tzhang@connectpharm.com

Study Locations

China
- Anhui
  - Hefei, Anhui, China, 230000
    - The Second Hospital of Anhui Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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:
- 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test drug (T1): CBP-201 injection (pre-filled syringe, 150 mg/1 mL) Strength: pre-filled syringe, 150 mg/1 mL	Biological: Test drug (T1): CBP-201 injection (pre-filled syringe, 150 mg/1 mL) subcutaneous injection of 2 doses on Day 1
Experimental: Test drug (T2): CBP-201 injection (pre-filled syringe, 300 mg/2 mL) Strength: pre-filled syringe, 300 mg/2 mL	Biological: Test drug (T2): CBP-201 injection (pre-filled syringe, 300 mg/2 mL) subcutaneous injection of 1 dose on Day 1
Active Comparator: Reference drug (R): CBP-201 injection (vial, 150 mg/1 mL) Strength: vial, 150 mg/1 mL	Biological: Reference drug (R): CBP-201 injection (vial, 150 mg/1 mL) subcutaneous injection of 2 doses on Day 1

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Connect Biopharmaceuticals, Ltd.

Investigators

Study Director: Suzhou Connect, Suzhou Connect Biopharmaceuticals, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2023

Primary Completion (Actual)

October 6, 2023

Study Completion (Actual)

October 6, 2023

Study Registration Dates

First Submitted

June 4, 2023

First Submitted That Met QC Criteria

June 14, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 29, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

CBP-201-CN004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Adult Subjects

Biogen

Completed

Multiple Dose Study Of BIIB118 (PF-05251749) In Healthy Volunteers

Healthy Adult Subjects | Healthy Elderly Subjects

United States
Pfizer

Completed

A Phase 1 Study To Characterize The Safety, Tolerability, PK And PK Of Repeat Doses Of PF-06648671 In Healthy Adults And Healthy Elderly Subjects

Healthy Adult Subjects and Healthy Elderly Subjects

Belgium
China Resources Biopharmaceutical Co., Ltd
Peking University Third Hospital

Recruiting

A Trial of CRB4101 in Healthy Subjects

Healthy Adult Subjects

China
Auzone Biological Technology Pty Ltd

Completed

Bioequivalence of TTYP01 Tablets in Healthy Adult Subjects

Healthy Adult Subjects

United States
Mitsubishi Tanabe Pharma Corporation

Completed

Comparative Bioavailability Study of Oral Edaravone Administered Orally and Via a Nasogastric Tube

Healthy Adult Subjects

Japan
Alvotech Swiss AG
Iqvia Pty Ltd

Completed

A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants

Healthy Adult Subjects

New Zealand, United Kingdom
Jiangsu HengRui Medicine Co., Ltd.

Completed

A Bioavailability Study of SHR1459 on Healthy Chinese Volunteers

Healthy Adult Subjects

China
Connect Biopharma Australia Pty Ltd

Completed

Safety, Tolerability and Pharmacokinetics of CBP-174 in Healthy Adults

Healthy Adult Subjects

Australia
Jiangsu HengRui Medicine Co., Ltd.

Completed

A Itraconazole Effect Study of SHR2554 on Healthy Chinese Adult Subjects

Healthy Adult Subjects

China
Nobelpharma

Completed

A Study of NPC-22 in Healthy Adult Males

Healthy Adult Subjects

Japan

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

Novartis Pharmaceuticals

Completed

Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis

Ankylosing Spondylitis

Japan
Leonardo Clavijo
Amgen

Unknown

Effect of Evolocumab in Functional Status and LDL Oxidation of Patients With Peripheral Arterial Disease (Evol-PAD)

Peripheral Arterial Disease

United States

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

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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Healthy Adult Subjects

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations