A Study to Evaluate Single-dose of HB0043 in Healthy Adult Participants (NCT06999083) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate Single-dose of HB0043 in Healthy Adult Participants
New Zealand52 participantsStarted 2025-06-03
Plain-language summary
The aim of this study is to investigate the safety and tolerability of HB0043 in healthy subjects following single-dose.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy male or female subjects age ≥ 18 and ≤ 55 years.
. Men and women of reproductive potential, willing to practice a highly effective method of birth control for the duration of the study and continuing for 6 months after receiving the last dose of drug administration. Highly effective methods of birth control include sexual abstinence (men, women); vasectomy or a condom (men) in combination with other barrier methods, hormonal birth control or IUD (women).
. Body Mass Index (BMI) ≥ 18 and ≤ 32 kg/m².
. No clinically significant findings in the medical history and physical examination.
. No clinically significant laboratory values (including urinalysis), unless the investigator considers any abnormality to not be clinically significant.
. Normal ECG, blood pressure, respiratory rate, temperature and heart rate, unless the investigator considers any abnormality to be not clinically significant.
. Informed consent must be obtained for all subjects enrolled into the study.
Exclusion criteria
. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of subjects with drug related adverse events (AEs)
. Family history of premature Coronary Heart Disease (CHD).
. Treatment in the previous 3 months with any drug known to have a well-defined potential for toxicity to a major organ. Exposure to any prescription medication 14 days prior to randomization, to herbal remedies or over-the countermedications (except for the occasional use of acetaminophen \[up to 2,000 mg per day\]) 7 days prior to randomization.
. Participation in another research with any investigational product within 28 days or 5 half-lives of the drug, whichever is greater, before screening.
. Known allergy to biologics.
. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing
. Had a vaccination with a live attenuated vaccine within 1 months prior to dosing.