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

Last updated: January 2, 2025
Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Placebo

HB0056

Clinical Study ID

NCT06612970
HB0056-HV-01-01
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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, unlessthe investigator considers any abnormality to be not clinically significant.

  • Signed and dated written informed consent prior to admission to the study inaccordance with GCP and local legislation.

Exclusion

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 HeartDisease (CHD)

  • History of clinically significant opportunistic infection (e.g., invasivecandidiasis or pneumocystis pneumonia).

  • Pregnant or Breasting feeding subject. Women with a positive pregnancy test .

  • Further exclusions criteria applied.

Study Design

Total Participants: 46
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
November 18, 2024
Estimated Completion Date:
October 01, 2025

Study Description

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

Connect with a study center

  • New Zealand Clinical Research

    Christchurch, 8011
    New Zealand

    Active - Recruiting

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