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RecruitingNCT06612970Updated Sep 8, 2025

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

A Phase 1 interventional study of HB0056 and Placebo in Healthy, sponsored by Shanghai Huaota Biopharmaceutical Co., Ltd.. Recruiting at 1 site in New Zealand. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-08.

Sponsored by Shanghai Huaota Biopharmaceutical Co., Ltd. · Phase 1, Interventional, and Other

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 10 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Healthy

Keywords

  • HB0056
03

In context

Lead sponsor

Shanghai Huaota Biopharmaceutical Co., Ltd. is the lead sponsor of 16 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
46 participants (estimated)

Study arms

  • Active comparator
    HB0056 dose group 1

    HB0056 single dose

    Drug: HB0056

  • Active comparator
    HB0056 dose group 2

    HB0056 single dose

    Drug: HB0056

  • Active comparator
    HB0056 dose group 3

    HB0056 single dose

    Drug: HB0056

  • Active comparator
    HB0056 dose group 4

    HB0056 single dose

    Drug: HB0056

  • Active comparator
    HB0056 dose group 5

    HB0056 single dose

    Drug: HB0056

  • Active comparator
    HB0056 dose group 6

    HB0056 single dose

    Drug: HB0056

  • Active comparator
    HB0056 dose group 7

    HB0056 single dose

    Drug: HB0056

  • Placebo comparator
    Matching placebo for each dose group

    placebo, single dose

    Drug: Placebo

Interventions

  • DrugHB0056

    HB0056 Injection

    Also known as: Targeting TSLP and IL-11 IgG1-type Bispecific Antibody

  • DrugPlacebo

    Placebo

    Also known as: No other invention name

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Up to 2700 hours

Secondary outcomes

  1. Cmax

    The maximum measured concentration of the analysis in plasma.

    Time frame: Up to 2700 hours

  2. AUC0-infinity

    The area under the concentration-time curve of the analysis in plasma over the time interval from 0 extrapolated to infinity

    Time frame: Up to 2700 hours

07

Study locations

1 of 1 sites recruiting
  • New Zealand Clinical Research
    Christchurch, 8011, New Zealand
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06612970
Lead sponsor
Shanghai Huaota Biopharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Sep 25, 2024
Start date
Nov 18, 2024
Primary completion
Jun 13, 2025
Completion
Oct 1, 2025 (estimated)
Last update
Sep 8, 2025

Study contacts

Jingjing Wang
Contact
jingjing.wang@huaota.com
086 15002154126
Xiaoyan Liu
Contact
xiaoyan.liu@huaota.com
086 15002154126
Cory Sellwood
principal investigator · New Zealand Clinical Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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