Status:
COMPLETED
A Study of Injection HB0017 in Adult Healthy Volunteers
Lead Sponsor:
Huabo Biopharm Co., Ltd.
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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,...
Eligibility Criteria
Inclusion
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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
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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.
Key Trial Info
Start Date :
October 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04505033
Start Date
October 2 2020
End Date
February 1 2021
Last Update
July 28 2021
Active Locations (1)
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1
Auckland Clinical Studies Ltd
Grafton, Auckland, New Zealand, 8963