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placebo by subcutaneous (SC) administration. Forty subjects (10 subjects per cohort for SC administration) will be randomized and assigned to up to 4 sequential doses cohorts of HB0017 (50 mg, 150 mg, 300 mg and 450 mg) or matching placebo. Each cohort of ten volunteers will be randomly assigned to receive either a single dose of HB0017 or matching placebo at a ratio of 4:1. Starting with the lowest dose, each of the subsequent doses will be administered only if the preceding dose was determined to be safe and well tolerated. The decision to escalate the next dose will be made jointly by the sponsor s medical expert and the investigator based upon review of 15-day blinded safety data prior to dosing each cohort.
Enrollment
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Volunteers
Inclusion criteria
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:
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:
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
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:
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.
Primary purpose
Allocation
Interventional model
Masking
40 participants in 8 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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