A Study to Evaluate HB0034 in Healthy Chinese Adult Participants

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Drug: HB0034; Drug: HB0034 matching placebo

• Registration Number: NCT06716151
• Lead Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

This study consisted of a single-dose escalation study and a multi-dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034 in Chinese healthy subjects.

Study Timeline

• Study First Submitted: 2024-11-29
• Study First Submitted QC: 2024-11-29
• Study First Posted: 2024-12-04
• Study Start: 2024-12-06
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-20
• Primary Completion: 2025-11-20
• Study Completion: 2025-11-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 exclusion criterias apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator: HB0034 dose group 1	HB0034	6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
Active Comparator: HB0034 dose group 2	HB0034	6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
Active Comparator: HB0034 dose group 5	HB0034	6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
Active Comparator: HB0034 dose group 6	HB0034	8 subjects receive a multi-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
Placebo group	HB0034 matching placebo	17 subjects receive placebo
Active Comparator: HB0034 dose group 3	HB0034	6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
Active Comparator: HB0034 dose group 7	HB0034	8 subjects receive a multi-dose of HB0034 a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
Active Comparator: HB0034 dose group 4	HB0034	6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with drug related adverse events (AEs)	up to 113 days	An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational drug

Secondary Outcome Measures

Name	Time	Method
Cmax	Up to 113 days	The maximum measured concentration of the analysis in plasma
AUC0-infinity	up to 113 days	The area under the concentration-time curve of the analysis in plasma over the time interval from 0 extrapolated to infinity

Trial Locations

Locations (1)

Central Hospital affiliated to Shandong First Medical University; 🇨🇳 Jinan, Shandong, China