Actively Recruiting
A Study to Evaluate Single-dose of HB0043 in Healthy Adult Participants
Led by Shanghai Huaota Biopharmaceutical Co., Ltd. · Updated on 2025-05-31
52
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this study is to investigate the safety and tolerability of HB0043 in healthy subjects following single-dose.
CONDITIONS
Official Title
A Study to Evaluate Single-dose of HB0043 in Healthy Adult Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male or female subjects aged 18 to 55 years
- Men and women of reproductive potential willing to use highly effective birth control during the study and for 6 months after dosing
- Body Mass Index (BMI) between 18 and 32 kg/m�b2
- No clinically significant findings in medical history and physical examination
- No clinically significant abnormal laboratory values unless deemed not significant by investigator
- Normal ECG, blood pressure, respiratory rate, temperature, and heart rate unless abnormalities are not clinically significant
- Must provide informed consent to participate in the study
You will not qualify if you...
- History of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease
- Current or history of cancer
- Family history of premature Coronary Heart Disease (CHD)
- Use of drugs with known organ toxicity within 3 months or any prescription medication within 14 days prior to randomization
- Participation in another investigational study within 28 days or 5 half-lives of the drug prior to screening
- Known allergy to biologic agents
- Plasma donation within 7 days or blood loss of 500 mL or more within 8 weeks prior to dosing
- Vaccination with live attenuated vaccine within 1 month prior to dosing
- Risk or evidence of active tuberculosis
- Positive screening tests for Hepatitis B, Hepatitis C, or HIV
- History of serious opportunistic infections
- Untreated or unresolved helminth parasitic infection within 6 months prior to screening
- Serious local or systemic infection within 3 months prior to screening
- Fever over 37.5�b0C within 2 weeks prior to dosing
- History of recent drug abuse or positive drug screen
- Excessive alcohol consumption within 6 months prior to screening
- Smoking more than 5 cigarettes per day within 3 months prior to screening
- Mental condition preventing understanding of the study
- Pregnant or breastfeeding women, positive pregnancy test, or planning to donate sperm or eggs during and 6 months after study
- Adults under guardianship or with legal restrictions on freedom
- Unlikely to comply with study protocol or complete the study
- Study staff or relatives directly involved in the study conduct
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
New Zealand Clinical Research , Grafton, Auckland, 3 Ferncroft Street,
Auckland, Grafton, New Zealand
Actively Recruiting
Research Team
X
xuewen Gan
CONTACT
X
xueqiong wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
7
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