A Study of Injection HB0017 in Adult Healthy Volunteers

Inclusion criteria

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

• Healthy male or female subjects age ≥ 18 and ≤ 55 years.
• Females of childbearing potential who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomized since at least 6 months) must be willing to use one of the following acceptable contraceptive method throughout the study and for 112 days after the study drug administration:

• Simultaneous use of intra-uterine contraceptive device without hormone release system placed at least 4 weeks prior to study drug administration, and condom for the male partner;
• Simultaneous use of diaphragm with intravaginally applied spermicide and male condom for the male partner, starting at least 21 days prior to study drug administration.
• Male subjects who are not vasectomized for at least 6 months, and who are sexually active with non-sterile female partner [sterile female partners include post-menopausal women (absence of menses for 12 months prior to drug administration) or women who have had a tubal ligation, hysterectomy, or bilateral oophorectomy (at least 6 months prior to drug administration)] must be willing to use one of the following acceptable contraceptive method throughout the study and for 112 days after the study drug administration:

• simultaneous use of condom, and for the female partner hormonal contraceptives (used since at least 4 weeks) or intra-uterine contraceptive device (placed since at least 4 weeks);
• simultaneous use of male condom, and for the female partner, diaphragm with intravaginally applied spermicide;
• Body Mass Index (BMI) ≥ 18.5 and ≤ 30 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 in writing for all subjects enrolled into the study.

Exclusion criteria

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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 (subjects with squamous cell skin cancer maybe included based on investigator assessment.).
• 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 counter medications 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.
• Any medical history of asthma, allergic rhinitis or urticarial, or any other clinically significant allergy reaction including food allergy. Known allergy to biologics.
• Blood or plasma donation of more than 500 mL during the previous 2 months and/or more than 50 mL in the 2 weeks prior to screening.
• Had a vaccination with a live attenuated vaccine within 6 months prior to dosing.
• Subjects at risk for tuberculosis (TB), specifically subjects with:

• Current clinical, radiographic or laboratorial evidence of active TB.
• History of active tuberculosis or exposure to endemic areas within 8 weeks prior to QuantiFERON®-TB testing performed at screening.
• Positive QuantiFERON®-TB test with positive chest X-ray, indicating possible tuberculosis infection. Subjects with positive QuantiFERON®-TB test with documented completion of treatment for latent TB can be included into the study.
• Positive test for hepatitis B, hepatitis C, or HIV at screening.
• History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).
• Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to screening.
• Presence of fever (body temperature > 37.6°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 per 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. Positive pregnancy test (HCG) within 3 days prior to Day 1.
• 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 thereof directly involved in the conduct of the study.