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A Trial of HBM9378 in Healthy Chinese Subjects

Primary Purpose

Asthma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HBM9378 (SKB378) Injection
Placebo
Sponsored by
Harbour BioMed (Guangzhou) Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Written informed consent must be obtained. Healthy Chinese male and female subjects aged 18 to 50 years (both included) are enrolled, no clinically significant abnormalities. Total body weight ≥45kg at screening, and body mass index(BMI)between 18 and 28 kg/m2 (inclusive). Female subjects must meet one of the following criteria for participation in this study: Of non-childbearing potential ; Male subjects and female subjects of childbearing potential must use an effective contraceptive method during their participation in this clinical study. Can communicate successfully with the investigator and understand and comply with the requirements of this study. Exclusion Criteria: History of relevant allergy/hypersensitivity. History of any of the following diseases: Any clinically significant comorbidity, as judged by the investigator. Clinical signs of active infection found at screening. Previous malignancy within the past 5 years. Acute or chronic bronchospastic disease within the past 3 years. Subject who are currently suffering from any medical condition. Subjects who have undergone organ transplantation. Received immunosuppressive therapy within 6 months prior to randomization. Received any biological product within 90 days or 5 half-lives (for other study drugs), whichever is longer, prior to randomization, or participated in another clinical study and received a study drug. Received any drug within 4 weeks prior to randomization. Subjects who had an immunization within 4 weeks prior to randomization; subjects who are scheduled to have an immunization during the study or within 4 weeks after the end of study. Donated or lost 400 mL or more blood, or received transfusion of blood or any blood product within 60 days prior to randomization. Subjects who are smokers or have used tobacco or nicotine-containing products within 3 months prior to randomization. Subjects who regularly consumed alcohol within 3 months prior to screening, or who had consumed alcohol after screening and before administration. Subjects who had been exposed to a tuberculosis (TB) patient within 6 months prior to randomization. Subjects who had drug abuse or a positive urine drug screen within 12 months prior to randomization. Pregnant or lactating women. Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody test result, or clinically significantly abnormal syphilis serology test result. History of immunodeficiency disease, including clinically significantly abnormal HIV antibody test result. Clinically significantly abnormal vital signs, physical examination, chest radiography, electrocardiogram , or laboratory tests , as judged by the investigator. In the investigator's judgment, may increase the risk to the subject.

Sites / Locations

  • The Fifth People's Hospital of ChengduRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HBM9378 (SKB378) Injection

Placebo

Arm Description

Dose: 20 mg/60 mg/200 mg/600 mg/900 mg Frequency: Once Injection subcutaneously

Dose: 20 mg/60 mg/200 mg/600 mg/900 mg Frequency: Once Injection subcutaneously

Outcomes

Primary Outcome Measures

Adverse events
Incidence and severity of adverse events
Pharmacokinetics-AUC0-last
Area under the concentration-time curve from time 0 to last time point after HBM9378 administration
Pharmacokinetics-Tmax
Time to Cmax of HBM9378
Pharmacokinetics-Cmax
Maximum observed concentration of HBM9378
Pharmacokinetics-CL/F
Apparent clearance of HBM9378
Pharmacokinetics-Vd/F
Apparent volume of distribution during terminal phase of HBM9378
Pharmacokinetics-T1/2
Terminal elimination half-life of HBM9378

Secondary Outcome Measures

Immunogenicity
The percentage of patients with anti-drug antibodies after administration.

Full Information

First Posted
February 27, 2023
Last Updated
March 16, 2023
Sponsor
Harbour BioMed (Guangzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05790694
Brief Title
A Trial of HBM9378 in Healthy Chinese Subjects
Official Title
A Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Phase I Clinical Study in Healthy Chinese Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of HBM9378 (SKB378) After Subcutaneous Administration.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 26, 2022 (Actual)
Primary Completion Date
September 22, 2023 (Anticipated)
Study Completion Date
September 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Harbour BioMed (Guangzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The objective is to evaluate the safety, tolerability and pharmacokinetic profile of a single subcutaneous injection of HBM9378 (SKB378) at different doses in healthy Chinese subjects.
Detailed Description
The study will consist of one dose esclation part with a total of 5 dose levels. The Subjects will be randomized to receive HBM9378 as reflected by the guiding principle for the dose esclation/expansion phase. Each dose group includes a screening period, a baseline period, an observational period, and a safety follow-up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HBM9378 (SKB378) Injection
Arm Type
Experimental
Arm Description
Dose: 20 mg/60 mg/200 mg/600 mg/900 mg Frequency: Once Injection subcutaneously
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dose: 20 mg/60 mg/200 mg/600 mg/900 mg Frequency: Once Injection subcutaneously
Intervention Type
Drug
Intervention Name(s)
HBM9378 (SKB378) Injection
Intervention Description
Strength: 225 mg (1.5 mL)/vial
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Strength: 225 mg (1.5 mL)/vial
Primary Outcome Measure Information:
Title
Adverse events
Description
Incidence and severity of adverse events
Time Frame
Strat of Treatment to end of study (approsimately 160days)
Title
Pharmacokinetics-AUC0-last
Description
Area under the concentration-time curve from time 0 to last time point after HBM9378 administration
Time Frame
Strat of Treatment to end of study (approsimately 160days)
Title
Pharmacokinetics-Tmax
Description
Time to Cmax of HBM9378
Time Frame
Strat of Treatment to end of study (approsimately 160days)
Title
Pharmacokinetics-Cmax
Description
Maximum observed concentration of HBM9378
Time Frame
Strat of Treatment to end of study (approsimately 160days)
Title
Pharmacokinetics-CL/F
Description
Apparent clearance of HBM9378
Time Frame
Strat of Treatment to end of study (approsimately 160days)
Title
Pharmacokinetics-Vd/F
Description
Apparent volume of distribution during terminal phase of HBM9378
Time Frame
Strat of Treatment to end of study (approsimately 160days)
Title
Pharmacokinetics-T1/2
Description
Terminal elimination half-life of HBM9378
Time Frame
Strat of Treatment to end of study (approsimately 160days)
Secondary Outcome Measure Information:
Title
Immunogenicity
Description
The percentage of patients with anti-drug antibodies after administration.
Time Frame
Strat of Treatment to end of study (approsimately 160days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Written informed consent must be obtained. Healthy Chinese male and female subjects aged 18 to 50 years (both included) are enrolled, no clinically significant abnormalities. Total body weight ≥45kg at screening, and body mass index(BMI)between 18 and 28 kg/m2 (inclusive). Female subjects must meet one of the following criteria for participation in this study: Of non-childbearing potential ; Male subjects and female subjects of childbearing potential must use an effective contraceptive method during their participation in this clinical study. Can communicate successfully with the investigator and understand and comply with the requirements of this study. Exclusion Criteria: History of relevant allergy/hypersensitivity. History of any of the following diseases: Any clinically significant comorbidity, as judged by the investigator. Clinical signs of active infection found at screening. Previous malignancy within the past 5 years. Acute or chronic bronchospastic disease within the past 3 years. Subject who are currently suffering from any medical condition. Subjects who have undergone organ transplantation. Received immunosuppressive therapy within 6 months prior to randomization. Received any biological product within 90 days or 5 half-lives (for other study drugs), whichever is longer, prior to randomization, or participated in another clinical study and received a study drug. Received any drug within 4 weeks prior to randomization. Subjects who had an immunization within 4 weeks prior to randomization; subjects who are scheduled to have an immunization during the study or within 4 weeks after the end of study. Donated or lost 400 mL or more blood, or received transfusion of blood or any blood product within 60 days prior to randomization. Subjects who are smokers or have used tobacco or nicotine-containing products within 3 months prior to randomization. Subjects who regularly consumed alcohol within 3 months prior to screening, or who had consumed alcohol after screening and before administration. Subjects who had been exposed to a tuberculosis (TB) patient within 6 months prior to randomization. Subjects who had drug abuse or a positive urine drug screen within 12 months prior to randomization. Pregnant or lactating women. Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody test result, or clinically significantly abnormal syphilis serology test result. History of immunodeficiency disease, including clinically significantly abnormal HIV antibody test result. Clinically significantly abnormal vital signs, physical examination, chest radiography, electrocardiogram , or laboratory tests , as judged by the investigator. In the investigator's judgment, may increase the risk to the subject.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Xu, Master
Phone
+86 15198081852
Email
xm15198081852@163.com
Facility Information:
Facility Name
The Fifth People's Hospital of Chengdu
City
Sichuan
State/Province
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Xu

12. IPD Sharing Statement

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A Trial of HBM9378 in Healthy Chinese Subjects

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