A Study to Evaluate Multi-dose of HB0034 in Healthy Adult Participants

Shanghai Huaota Biopharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Recombinant Humanized Anti-IL-36R Monoclonal antibody and Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05460455

HB0034-03

Details and patient eligibility

About

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

Full description

This is a multi-dose escalation study of HB0034 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034.

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 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 exclusions criteria apply.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups

HB0034 dose group 1

Active Comparator group

Description:

8 subjects receive a multi-dose of HB0034 and 2 subjects receive a multi-dose placebo

Treatment:

Drug: Recombinant Humanized Anti-IL-36R Monoclonal antibody and Placebo

HB0034 dose group 2

Active Comparator group

Description:

8 subjects receive a multi-dose of HB0034 and 2 subjects receive a multi-dose placebo

Treatment:

Drug: Recombinant Humanized Anti-IL-36R Monoclonal antibody and Placebo

HB0034 dose group 3

Active Comparator group

Description:

8 subjects receive a multi-dose of HB0034 and 2 subjects receive a multi-dose placebo

Treatment:

Drug: Recombinant Humanized Anti-IL-36R Monoclonal antibody and Placebo