A Study to Evaluate Single-dose of HB0043 in Healthy Adult Participants

This is a single-dose escalation study of HB0043 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0043.

Inclusion criteria

• Subjects must meet the following criteria to be eligible for study entry:

• 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

Subjects who meet any of the following criteria will be excluded from study entry:

• 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).
• 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.
• Subjects at risk for tuberculosis (TB), specifically subjects with:

• Current clinical, radiographic or laboratorial evidence of active TB;
• Positive interferon-γ release assay (IGRA) test.
• Positive test at screening for any of the following infectious disease tests: Hepatitis B, surface antigen (HBsAg), Hepatitis C virus antibody (HCV Ab), Human immunodeficiency virus antibody (HIV Ab).
• History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).
• A helminth parasitic infection diagnosed within 6 months prior to screening that has not been treated with, or has failed to respond to, standard of care therapy.
• Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to screening.
• Presence of fever (body temperature >37.5°C) (e.g., a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to the first dosing.
• History of drug abuse within 1 year prior to screening, or use of soft drugs (such as marijuana) within 3 months prior to the screening, or hard drugs (such as cocaine, phencyclidine, and crack) within 1 year prior to screening. Positive drug screen (cocaine, methamphetamine, phencyclidine, and Tetrahydrocannabinol) at screening or Day -1.
• History of regular alcohol consumption exceeding 14 drinks/week for female subjects or 21 drinks/week for male subjects (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before screening. Positive Breath Alcohol Test at screening or Day -1.
• Current cigarette smoker (cigarettes or e-cigarettes) who smoke over 5 cigarettes/day within 3 months prior to screening.
• Mental condition rendering the subject incapable of understanding the nature, scope, and possible consequences of the study.
• Pregnant or Breasting feeding subject. Women with positive pregnancy test (hCG). Or subjects who plan to donate sperms or eggs, from dosing until at least 6 months after last dose of investigational medicine.
• Adults under guardianship and people with restriction of freedom by administrative and legal decisions.
• Unlikely to comply with the clinical study protocol, e.g. uncooperative attitude, inability to return for followed-up visit, and improbability of completing the study.
• Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative there of directly involved in the conduct of the study.