A Study to Evaluate HB0034 in Healthy Chinese Adult Participants

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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: HB0034; Drug: HB0034 matching placebo

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yuan Tang; Phone Number: +86 15821321563; Email: yuan.tang@huaota.com
• Study Contact Backup: Name: Qiaoxia Qian; Phone Number: +86 18555690860; Email: qiaoxia.qian@huaota.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Central Hospital Affiliated to Shandong First Medical University
      • Contact: Qing Wen
      • Contact: Li Cuigang; Phone Number: +860531-55566416; Email: zxyyywsy@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Comparator: HB0034 dose group 1; 6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody	Drug: HB0034; Recombinant Humanized Anti-IL-36R Monoclonal antibody
Experimental: Active Comparator: HB0034 dose group 2; 6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody	Drug: HB0034; Recombinant Humanized Anti-IL-36R Monoclonal antibody
Experimental: Active Comparator: HB0034 dose group 3; 6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody	Drug: HB0034; Recombinant Humanized Anti-IL-36R Monoclonal antibody
Experimental: Active Comparator: HB0034 dose group 4; 6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody	Drug: HB0034; Recombinant Humanized Anti-IL-36R Monoclonal antibody
Experimental: Active Comparator: HB0034 dose group 5; 6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody	Drug: HB0034; Recombinant Humanized Anti-IL-36R Monoclonal antibody
Experimental: Active Comparator: HB0034 dose group 6; 8 subjects receive a multi-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody	Drug: HB0034; Recombinant Humanized Anti-IL-36R Monoclonal antibody
Experimental: Active Comparator: HB0034 dose group 7; 8 subjects receive a multi-dose of HB0034 a recombinant humanized anti-IL-36R IgG1 monoclonal antibody	Drug: HB0034; Recombinant Humanized Anti-IL-36R Monoclonal antibody
Placebo Comparator: Placebo group; 17 subjects receive placebo	Drug: HB0034 matching placebo; HB0034 matching Palcebo

What is the study measuring?

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 the investigational drug	up to 113 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2024
• Primary Completion (Estimated): November 20, 2025
• Study Completion (Estimated): November 20, 2025

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: November 29, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Healthy subjects
• Other Study ID Numbers: HB0034-HV-01-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No