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

NCT ID: NCT06612970

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-18

Study Completion Date

2025-10-01

Brief Summary

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

Detailed Description

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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HB0056 dose group 1

HB0056 single dose

Group Type ACTIVE_COMPARATOR

HB0056

Intervention Type DRUG

HB0056 Injection

HB0056 dose group 2

HB0056 single dose

Group Type ACTIVE_COMPARATOR

HB0056

Intervention Type DRUG

HB0056 Injection

HB0056 dose group 3

HB0056 single dose

Group Type ACTIVE_COMPARATOR

HB0056

Intervention Type DRUG

HB0056 Injection

HB0056 dose group 4

HB0056 single dose

Group Type ACTIVE_COMPARATOR

HB0056

Intervention Type DRUG

HB0056 Injection

HB0056 dose group 5

HB0056 single dose

Group Type ACTIVE_COMPARATOR

HB0056

Intervention Type DRUG

HB0056 Injection

HB0056 dose group 6

HB0056 single dose

Group Type ACTIVE_COMPARATOR

HB0056

Intervention Type DRUG

HB0056 Injection

HB0056 dose group 7

HB0056 single dose

Group Type ACTIVE_COMPARATOR

HB0056

Intervention Type DRUG

HB0056 Injection

Matching placebo for each dose group

placebo, single dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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HB0056

HB0056 Injection

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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Targeting TSLP and IL-11 IgG1-type Bispecific Antibody No other invention name

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Huaota Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cory Sellwood

Role: PRINCIPAL_INVESTIGATOR

New Zealand Clinical Research

Locations

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New Zealand Clinical Research

Christchurch, , New Zealand

Site Status RECRUITING

Countries

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New Zealand

Central Contacts

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Jingjing Wang

Role: CONTACT

086 15002154126

Xiaoyan Liu

Role: CONTACT

086 15002154126

Facility Contacts

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Lucia Druzianic

Role: primary

+ 64 9 373 3474 ext. 7221

Other Identifiers

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HB0056-HV-01-01

Identifier Type: -

Identifier Source: org_study_id

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