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Completed

NCT Number: NCT05064345

A Study to Evaluate HB0034 in Healthy Adult Participants

The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following a single 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 first-in-human (FIH) 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 (HCG).
  • Further exclusions criteria apply.

Treatment and study plan

HB0034

Drug

Recombinant Humanized Anti-IL-36R Monoclonal antibody

Other names: no other invention names

Placebo

Drug

Palcebo

Other names: no other invention 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

Other outcomes

  1. 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 Ia, Randomized, Double-blind, Placebo-controlled, Single Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HB0034 in Adult Healthy Subjects

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 1, 2021
Registry last updated
Sep 14, 2022

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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