RecruitingPhase 1NCT06716151

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

Sponsor

Shanghai Huaota Biopharmaceutical Co., Ltd.

Enrollment

60 participants

Start Date

Dec 6, 2024

Study Type

INTERVENTIONAL

Conditions

Healthy

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.

Eligibility

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria4

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 Criteria4

\- 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.

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Interventions

DRUGHB0034

Recombinant Humanized Anti-IL-36R Monoclonal antibody

DRUGHB0034 matching placebo

HB0034 matching Palcebo

Locations(1)

Central Hospital affiliated to Shandong First Medical University

Jinan, Shandong, China

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