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

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.

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Recombinant Humanized Anti-IL-36R Monoclonal antibody and Placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand
    • New Zealand Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (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 exclusions criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

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 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
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 2000 hours

Collaborators and Investigators

• Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Christian Schwabe, NZCR OpCo limited AKL

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2022
• Primary Completion (Actual): June 9, 2023
• Study Completion (Actual): December 8, 2023

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 21, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Antibodies; Antibodies, Monoclonal
• Other Study ID Numbers: HB0034-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No