A Study to Evaluate Single-dose of HB0056 in Healthy Adult Participants

A Phase 1a, Randomized, Double-blind, Placebo-controlled, Single Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HB0056 in Adult Healthy Subjects.

The aim of this study is to investigate the safety and tolerability of HB0056 in healthy subjects following single-dose.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: HB0056

Detailed Description

This is a single-dose escalation study of HB0056 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0056.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jingjing Wang; Phone Number: 086 15002154126; Email: jingjing.wang@huaota.com
• Study Contact Backup: Name: Xiaoyan Liu; Phone Number: 086 15002154126; Email: xiaoyan.liu@huaota.com

Study Locations

• New Zealand
  • Christchurch, New Zealand, 8011
    • Recruiting
    • New Zealand Clinical Research
    • Contact: Lucia Druzianic; Phone Number: + 64 9 373 3474 ext. 7221; Email: lucy.druzianic@nzcr.co.nz

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) ≥ 18 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 applied.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Matching placebo for each dose group; placebo, single dose	Drug: Placebo; Placebo; Other Names: No other invention name
Active Comparator: HB0056 dose group 1; HB0056 single dose	Drug: HB0056; HB0056 Injection; Other Names: Targeting TSLP and IL-11 IgG1-type Bispecific Antibody
Active Comparator: HB0056 dose group 2; HB0056 single dose	Drug: HB0056; HB0056 Injection; Other Names: Targeting TSLP and IL-11 IgG1-type Bispecific Antibody
Active Comparator: HB0056 dose group 3; HB0056 single dose	Drug: HB0056; HB0056 Injection; Other Names: Targeting TSLP and IL-11 IgG1-type Bispecific Antibody
Active Comparator: HB0056 dose group 4; HB0056 single dose	Drug: HB0056; HB0056 Injection; Other Names: Targeting TSLP and IL-11 IgG1-type Bispecific Antibody
Active Comparator: HB0056 dose group 5; HB0056 single dose	Drug: HB0056; HB0056 Injection; Other Names: Targeting TSLP and IL-11 IgG1-type Bispecific Antibody
Active Comparator: HB0056 dose group 6; HB0056 single dose	Drug: HB0056; HB0056 Injection; Other Names: Targeting TSLP and IL-11 IgG1-type Bispecific Antibody
Active Comparator: HB0056 dose group 7; HB0056 single dose	Drug: HB0056; HB0056 Injection; Other Names: Targeting TSLP and IL-11 IgG1-type Bispecific Antibody

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 2700 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	The maximum measured concentration of the analysis in plasma.	Up to 2700 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 2700 hours

Collaborators and Investigators

• Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Cory Sellwood, New Zealand Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2024
• Primary Completion (Actual): June 13, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: HB0056
• Additional Relevant MeSH Terms: Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: HB0056-HV-01-01

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
• product manufactured in and exported from the U.S.: No