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

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Drug: HB0056; Drug: Placebo

• Registration Number: NCT06612970
• Lead Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-23
• Study First Posted: 2024-09-25
• Study Start: 2024-11-18
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-06-25
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
HB0056 dose group 1	HB0056	HB0056 single dose
HB0056 dose group 2	HB0056	HB0056 single dose
HB0056 dose group 3	HB0056	HB0056 single dose
HB0056 dose group 4	HB0056	HB0056 single dose
HB0056 dose group 5	HB0056	HB0056 single dose
HB0056 dose group 6	HB0056	HB0056 single dose
HB0056 dose group 7	HB0056	HB0056 single dose
Matching placebo for each dose group	Placebo	placebo, single dose

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

New Zealand Clinical Research; 🇳🇿 Christchurch, New Zealand