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

September 5, 2025 updated by: Shanghai Huaota Biopharmaceutical Co., Ltd.

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • New Zealand
      • Christchurch, New Zealand, 8011
        • Recruiting
        • New Zealand Clinical Research
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: Up to 2700 hours
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
Time Frame: Up to 2700 hours
The maximum measured concentration of the analysis in plasma.
Up to 2700 hours
AUC0-infinity
Time Frame: Up to 2700 hours
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

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Huaota Biopharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Cory Sellwood, New Zealand Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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