A Study to Evaluate Single-dose of HB0056 in Healthy Adult Participants

Shanghai Huaota Biopharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: HB0056; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06612970

HB0056-HV-01-01

Details and patient eligibility

About

The aim of this study is to investigate the safety and tolerability of HB0056 in healthy subjects following single-dose.

Full description

This is a single-dose escalation study of HB0056 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0056.

Enrollment: 46 estimated 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) ≥ 18 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 applied.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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46 participants in 8 patient groups, including a placebo group

HB0056 dose group 1

Active Comparator group

Description:

HB0056 single dose

Treatment:

Drug: HB0056

HB0056 dose group 2

Active Comparator group

Description:

HB0056 single dose

Treatment:

Drug: HB0056

HB0056 dose group 3

Active Comparator group

Description:

HB0056 single dose

Treatment:

Drug: HB0056

HB0056 dose group 4

Active Comparator group

Description:

HB0056 single dose

Treatment:

Drug: HB0056

HB0056 dose group 5

Active Comparator group

Description:

HB0056 single dose

Treatment:

Drug: HB0056

HB0056 dose group 6

Active Comparator group

Description:

HB0056 single dose

Treatment:

Drug: HB0056

HB0056 dose group 7

Active Comparator group

Description:

HB0056 single dose

Treatment:

Drug: HB0056

Matching placebo for each dose group

Placebo Comparator group

Description:

placebo, single dose

Treatment:

Drug: Placebo