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.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06612970

Enrollment

Registered

2024-09-25

Start date

2024-11-18

Completion date

2025-10-01

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

HB0056

Brief summary

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

Detailed description

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

Interventions

DRUGHB0056

HB0056 Injection

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of subjects with drug related adverse events (AEs)	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

Secondary

Measure	Time frame	Description
Cmax	Up to 2700 hours	The maximum measured concentration of the analysis in plasma.
AUC0-infinity	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

Countries

New Zealand

Contacts

Primary ContactJingjing Wang

jingjing.wang@huaota.com086 15002154126

Backup ContactXiaoyan Liu

xiaoyan.liu@huaota.com086 15002154126

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026