A Phase I Study Evaluating the Safety, Tolerability, PK and PD in Healthy Chinese Volunteers

Study Overview
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Brief Summary
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Trial Objective: To investigate the safety, tolerability, PK, and PD following single ascending doses of HBM9161 in healthy Chinese subjects.

Detailed Description
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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.

Official Title
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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of HBM9161(HL161BKN) in Healthy Chinese Volunteers (Randomized, Single-blinded, Placebo-controlled Trial)

Conditions
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Healthy Chinese Volunteers

Intervention / Treatment
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* Drug: HBM9161(HL161BKN)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HBM9161 340mg<br> | Drug: HBM9161(HL161BKN)<br>* Subcutaneous injection; Single dose on Day 1<br>|
| Experimental: HBM9161 510mg<br> | Drug: HBM9161(HL161BKN)<br>* Subcutaneous injection; Single dose on Day 1<br>|
| Experimental: HBM9161 680mg<br> | Drug: HBM9161(HL161BKN)<br>* Subcutaneous injection; Single dose on Day 1<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Subcutaneous injection; Single dose on Day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number [N (%)] of subjects with drug-related AEs | The number [N (%)] of subjects with drug-related AEs | 85 days |