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NCT Number: NCT06716151

A Study to Evaluate HB0034 in Healthy Chinese Adult Participants

The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following a single dose or multiple dose.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Central Hospital affiliated to Shandong First Medical University

Jinan, Shandong, China

Location status: Recruiting

Location contact

Li Cuigang

CONTACT

[email protected]

+860531-55566416

Qing Wen

CONTACT

About this study

This study consisted of a single-dose escalation study and a multi-dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034 in Chinese healthy subjects.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male or female subjects age ≥ 18 and ≤ 55 years.
  • Body Mass Index (BMI) ≥ 17.5 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 exclusion criterias apply.

Treatment and study plan

HB0034

Drug

Recombinant Humanized Anti-IL-36R Monoclonal antibody

HB0034 matching placebo

Drug

HB0034 matching Palcebo

Primary outcomes

  1. Percentage of subjects with drug related adverse events (AEs)

    Time frame: up to 113 days

    An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational drug

Secondary outcomes

  1. Cmax

    Time frame: Up to 113 days

    The maximum measured concentration of the analysis in plasma

  2. AUC0-infinity

    Time frame: up to 113 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Qiaoxia Qian

CONTACT

[email protected]

+86 18555690860

Yuan Tang

CONTACT

[email protected]

+86 15821321563

Sponsors and collaborators

Lead sponsor

Shanghai Huaota Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase I, Randomized, Double-blind, Placebo-controlled, Single/mulit Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HB0034 in Adult Healthy Subjects

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2024
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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