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Completed

NCT Number: NCT05460455

A Study to Evaluate Multi-dose of HB0034 in Healthy Adult Participants

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New zealand Clinical Research

Auckland, New Zealand

About this study

This is a multi-dose escalation study of HB0034 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034.

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 exclusions criteria apply.

Treatment and study plan

Recombinant Humanized Anti-IL-36R Monoclonal antibody and Placebo

Drug

HB0034 and Placebo

Other names: no other names

Primary outcomes

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

    Time frame: up to 2000 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 outcomes

  1. Cmax

    Time frame: up to 2000 hours

    The maximum measured concentration of the analysis in plasma

  2. AUC0-infinity

    Time frame: up to 2000 hours

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

Sponsors and collaborators

Lead sponsor

Shanghai Huaota Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase Ic, Randomized, Double-blind, Placebo-controlled, Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HB0034 in Adult Healthy Subjects.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 15, 2022
Registry last updated
Jan 23, 2024

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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