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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03971916
Recruitment Status : Completed
First Posted : June 3, 2019
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
Harbour BioMed (Guangzhou) Co. Ltd.

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

Condition or disease Intervention/treatment Phase
Healthy Chinese Volunteers Drug: HBM9161(HL161BKN) Drug: Placebo Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of HBM9161(HL161BKN) in Healthy Chinese Volunteers (Randomized, Single-blinded, Placebo-controlled Trial)
Actual Study Start Date : June 3, 2019
Actual Primary Completion Date : November 6, 2019
Actual Study Completion Date : November 6, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: HBM9161 340mg Drug: HBM9161(HL161BKN)
Subcutaneous injection; Single dose on Day 1
Experimental: HBM9161 510mg Drug: HBM9161(HL161BKN)
Subcutaneous injection; Single dose on Day 1
Experimental: HBM9161 680mg Drug: HBM9161(HL161BKN)
Subcutaneous injection; Single dose on Day 1
Placebo Comparator: Placebo Drug: Placebo
Subcutaneous injection; Single dose on Day 1


Outcome Measures
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Primary Outcome Measures :
  1. The number [N (%)] of subjects with drug-related AEs [ Time Frame: 85 days ]
    The number [N (%)] of subjects with drug-related AEs


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Han Chinese male or female subjects, and his/her biological parents and grandparents are of Han Chinese ethnicity.
  2. Body weight ≥ 50kg with BMI ≥19.0 and <=24.0 kg/m2 at screening and baseline visit.
  3. 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:

  1. Subject has a total IgG level of < 700mg/dL at screening.
  2. 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).
  3. History of relevant allergy/hypersensitivity (including allergy to study drug or its excipients).
  4. Any laboratory values outside the reference range that are of clinical significance according to investigator's clinical judgement.
  5. Subject has estimated creatinine clearance ≤ 80 mL/min calculated by Cockcroft Gault formula at screening.
  6. Subject has any ECG abnormality defined in the protocol (a single repeat will be allowed for eligibility determination) at screening or Day -1:
  7. Positive HIV test result at screening.
  8. Positive testing for HBs Antigen and/or a positive Hepatitis C antibody test result at screening.
  9. Subject has a positive T-cell interferon-γ release assay (TIGRA) result
  10. 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.
  11. 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.
  12. Lactating female subjects.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03971916


Locations
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China
Queen Mary Hospital, Phase 1 Clinical Trials Centre
Hong Kong, China
Sponsors and Collaborators
Harbour BioMed (Guangzhou) Co. Ltd.
Investigators
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Principal Investigator: Desmond Yat Hin YAP Queen Mary Hospital, Phase 1 Clinical Trials Centre
More Information
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Responsible Party: Harbour BioMed (Guangzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT03971916    
Other Study ID Numbers: 9161.1
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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