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Recruiting Phase 1 NCT06612970

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

Phase 1 – testing safety in a small group of people
Conditions: Healthy

Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.

trial.available_in: БГ
Overview
The aim of this study is to investigate the safety and tolerability of HB0056 in healthy subjects following single-dose.
Description
This is a single-dose escalation study of HB0056 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0056.
Who can participate
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.
Locations 1
New Zealand (1)
New Zealand Clinical Research
Christchurch
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
55 Years
Healthy volunteers
No
Start date
18.11.2024
Completion date
01.10.2025
Registry ID
NCT06612970
Source
anzctr
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