A Study to Evaluate HB0034 in Healthy Adult Participants

Study Overview
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Brief Summary
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The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following a single dose.

Detailed Description
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This is a first-in-human (FIH) study of HB0034 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034.

Official Title
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A Phase Ia, Randomized, Double-blind, Placebo-controlled, Single Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HB0034 in Adult Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: HB0034
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 (HCG). Further exclusions criteria apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HB0034 dose group 1<br>HB0034 single dose | Drug: HB0034<br>* Recombinant Humanized Anti-IL-36R Monoclonal antibody<br>* Other names: no other invention names;|
| Active Comparator: HB0034 dose group 2<br>HB0034 single dose | Drug: HB0034<br>* Recombinant Humanized Anti-IL-36R Monoclonal antibody<br>* Other names: no other invention names;|
| Active Comparator: HB0034 dose group 3<br>HB0034 single dose | Drug: HB0034<br>* Recombinant Humanized Anti-IL-36R Monoclonal antibody<br>* Other names: no other invention names;|
| Active Comparator: HB0034 dose group 4<br>HB0034 single dose | Drug: HB0034<br>* Recombinant Humanized Anti-IL-36R Monoclonal antibody<br>* Other names: no other invention names;|
| Active Comparator: HB0034 dose group 5<br>HB0034 single dose | Drug: HB0034<br>* Recombinant Humanized Anti-IL-36R Monoclonal antibody<br>* Other names: no other invention names;|
| Active Comparator: HB0034 dose group 6<br>HB0034 single dose | Drug: HB0034<br>* Recombinant Humanized Anti-IL-36R Monoclonal antibody<br>* Other names: no other invention names;|
| Active Comparator: HB0034 dose group 7<br>HB0034 single dose | Drug: HB0034<br>* Recombinant Humanized Anti-IL-36R Monoclonal antibody<br>* Other names: no other invention names;|
| Placebo Comparator: Matching placebo for each dose group<br>placebo, single dose | Drug: Placebo<br>* Palcebo<br>* Other names: no other invention names;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with drug related adverse events (AEs) | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational drug | up to 2000 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | The maximum measured concentration of the analysis in plasma | up to 2000 hours |