- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03971916
A Phase I Study Evaluating the Safety, Tolerability, PK and PD in Healthy Chinese Volunteers
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of HBM9161(HL161BKN) in Healthy Chinese Volunteers (Randomized, Single-blinded, Placebo-controlled Trial)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
HBM9161(HL161BKN) is a human monoclonal antibody. HBM9161 targets the neonatal Fc receptor (FcRn) . The neonatal FcRn is a potential therapeutic target for many autoimmune diseases. This Phase I study will evaluate the safety, tolerability, PK, and PD of subcutaneous (SC) doses of HBM9161(HL161BKN) (abbreviated as HBM9161) in healthy Chinese subjects. Up to 24 healthy Chinese subjects will be randomized into the study. For each dose group, 8 subjects will be randomized (6 subjects to HBM9161 group and 2 subjects to placebo group).
This study will also provide guidance on doses to be used in future studies involving patients with autoimmune diseases.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Hong Kong, China
- Queen Mary Hospital, Phase 1 Clinical Trials Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Han Chinese male or female subjects, and his/her biological parents and grandparents are of Han Chinese ethnicity.
- Body weight ≥ 50kg with BMI ≥19.0 and <=24.0 kg/m2 at screening and baseline visit.
- Generally, in good health with no clinically significant abnormalities as determined by medical history, physical examination, 12-lead ECG and clinical laboratory tests.
Exclusion Criteria:
- Subject has a total IgG level of < 700mg/dL at screening.
- Subject has an active infection or has had a serious infection within 6 weeks prior to Day -1 or infection requiring oral anti-infective agents within 2 weeks prior to Day-1, or subject had a febrile illness or symptomatic, viral, bacterial, or fungal infection within 1 week prior to admission (Day -1).
- History of relevant allergy/hypersensitivity (including allergy to study drug or its excipients).
- Any laboratory values outside the reference range that are of clinical significance according to investigator's clinical judgement.
- Subject has estimated creatinine clearance ≤ 80 mL/min calculated by Cockcroft Gault formula at screening.
- Subject has any ECG abnormality defined in the protocol (a single repeat will be allowed for eligibility determination) at screening or Day -1:
- Positive HIV test result at screening.
- Positive testing for HBs Antigen and/or a positive Hepatitis C antibody test result at screening.
- Subject has a positive T-cell interferon-γ release assay (TIGRA) result
- Subjects who had immunization within 4 weeks before screening; or subjects who plan to have immunization during the study and within 12 weeks after dosing of the study drug.
- For female subjects, positive pregnancy test at screening or Day -1, or planning to become pregnant from screening until 90 days after the dosing of the study drug.
- Lactating female subjects.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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Subcutaneous injection; Single dose on Day 1
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Experimental: HBM9161 340mg
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Subcutaneous injection; Single dose on Day 1
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Experimental: HBM9161 510mg
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Subcutaneous injection; Single dose on Day 1
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Experimental: HBM9161 680mg
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Subcutaneous injection; Single dose on Day 1
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number [N (%)] of subjects with drug-related AEs
Time Frame: 85 days
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The number [N (%)] of subjects with drug-related AEs
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85 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Desmond Yat Hin YAP, Queen Mary Hospital, Phase 1 Clinical Trials Centre
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
- 9161.1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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