A Study to Evaluate HB0034 in Healthy Chinese Adult Participants

Shanghai Huaota Biopharmaceutical

Status and phase

Enrolling

Phase 1

Conditions

Healthy

Treatments

Drug: HB0034 matching placebo

Drug: HB0034

Study type

Interventional

Funder types

Industry

Identifiers

NCT06716151

HB0034-HV-01-03

Details and patient eligibility

About

The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following a single dose or multiple dose.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 8 patient groups, including a placebo group

Active Comparator: HB0034 dose group 1

Experimental group

Description: