A Study to Evaluate HB0034 in Healthy Chinese Adult Participants

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT06716151

Run by

Shanghai Huaota Biopharmaceutical Co., Ltd.

People needed

60

Starts

2024-12-06

Expected to finish

2025-11-20

Last updated by the study team

2025-01-20

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Central Hospital affiliated to Shandong First Medical University — Jinan, Shandong, China (enrolling)

Full record on ClinicalTrials.gov

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