A Study to Evaluate HB0034 in Healthy Chinese Adult Participants

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06716151

Enrollment

Registered

2024-12-04

Start date

2024-12-06

Completion date

2025-11-20

Last updated

2025-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy subjects

Brief summary

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

DRUGHB0034

Recombinant Humanized Anti-IL-36R Monoclonal antibody

DRUGHB0034 matching placebo

HB0034 matching Palcebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of subjects with drug related adverse events (AEs)	up to 113 days	An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational drug

Secondary

Measure	Time frame	Description
Cmax	Up to 113 days	The maximum measured concentration of the analysis in plasma
AUC0-infinity	up to 113 days	The area under the concentration-time curve of the analysis in plasma over the time interval from 0 extrapolated to infinity

Countries

China

Contacts

Primary ContactYuan Tang

yuan.tang@huaota.com+86 15821321563

Backup ContactQiaoxia Qian

qiaoxia.qian@huaota.com+86 18555690860

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026