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A Study to Evaluate Multi-dose of HB0034 in Healthy Adult Participants

Sponsor
Shanghai Huaota Biopharmaceutical Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05460455
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
14
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following multiple-dose.

Condition or Disease Intervention/Treatment Phase
  • Drug: Recombinant Humanized Anti-IL-36R Monoclonal antibody and Placebo
 Phase 1

Detailed Description

This is a multi-dose escalation study of HB0034 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
A Phase Ic, Randomized, Double-blind, Placebo-controlled, Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HB0034 in Adult Healthy Subjects.
Anticipated Study Start Date :
Oct 31, 2022
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: HB0034 dose group 1

8 subjects receive a multi-dose of HB0034 and 2 subjects receive a multi-dose placebo

Drug: Recombinant Humanized Anti-IL-36R Monoclonal antibody and Placebo
HB0034 and Placebo
Other Names:
  • no other names

    		•
    Active Comparator: HB0034 dose group 2

    8 subjects receive a multi-dose of HB0034 and 2 subjects receive a multi-dose placebo

    Drug: Recombinant Humanized Anti-IL-36R Monoclonal antibody and Placebo
    HB0034 and Placebo
    Other Names:
  • no other names

    		•
    Active Comparator: HB0034 dose group 3

    8 subjects receive a multi-dose of HB0034 and 2 subjects receive a multi-dose placebo

    Drug: Recombinant Humanized Anti-IL-36R Monoclonal antibody and Placebo
    HB0034 and Placebo
    Other Names:
  • no other names

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of subjects with drug related adverse events (AEs) [up to 2000 hours]

      An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational drug

    Secondary Outcome Measures

    1. Cmax [up to 2000 hours]

      The maximum measured concentration of the analysis in plasma

    2. AUC0-infinity [up to 2000 hours]

      The area under the concentration-time curve of the analysis in plasma over the time interval from 0 extrapolated to infinity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy male or female subjects age ≥ 18 and ≤ 55 years.

    • Body Mass Index (BMI) ≥ 17.5 and ≤ 32 kg/m².

    • Normal ECG, blood pressure, respiratory rate, temperature, and heart rate, unless the investigator considers any abnormality to be not clinically significant.

    • Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.

    Exclusion Criteria:

    • History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease.

    • Current or history of malignancy. • Family history of premature Coronary Heart Disease (CHD)

    • History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).

    • Pregnant or Breasting feeding subject. Women with a positive pregnancy test .

    • Further exclusions criteria apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New zealand Clinical Research Auckland New Zealand

    Sponsors and Collaborators

    • Shanghai Huaota Biopharmaceutical Co., Ltd.

    Investigators

    • Principal Investigator: Christian Schwabe, NZCR OpCo limited AKL

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai Huaota Biopharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT05460455
    Other Study ID Numbers:
    • HB0034-03
    First Posted:
    Jul 15, 2022
    Last Update Posted:
    Jul 19, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Antibodies
    Antibodies, Monoclonal

    Study Results

    No Results Posted as of Jul 19, 2022