RecruitingPhase 1NCT06612970

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

A Phase 1a, Randomized, Double-blind, Placebo-controlled, Single Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HB0056 in Adult Healthy Subjects.

Sponsor

Shanghai Huaota Biopharmaceutical Co., Ltd.

Enrollment

46 participants

Start Date

Nov 18, 2024

Study Type

INTERVENTIONAL

Conditions

Healthy

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria4

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 Criteria5

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.

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