A Study to Evaluate HB0034 in Healthy Chinese Adult Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HB0034, HB0034 matching placebo.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following a single dose or multiple dose.
Detailed description
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.
Interventions
- Drug HB0034
Recombinant Humanized Anti-IL-36R Monoclonal antibody - Drug HB0034 matching placebo
HB0034 matching Palcebo
Primary outcome measures
- Percentage of subjects with drug related adverse events (AEs) [Time frame: up to 113 days]
Secondary outcome measures (2)
- Cmax [Time frame: Up to 113 days]
- AUC0-infinity [Time frame: up to 113 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Central Hospital affiliated to Shandong First Medical University — Jinan
Identifiers
NCT: NCT06716151 · HB0034-HV-01-03