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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04505033




Registration number
NCT04505033
Ethics application status
Date submitted
4/08/2020
Date registered
7/08/2020
Date last updated
28/07/2021

Titles & IDs
Public title
A Study of Injection HB0017 in Adult Healthy Volunteers
Scientific title
A Phase I, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HB0017 Following a Single Dose in Adult Healthy Volunteers
Secondary ID [1] 0 0
HB0017-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Subjects 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HB0017
Treatment: Drugs - placebo

Experimental: 50 mg s.c -

Placebo Comparator: 50 mg placebo -

Experimental: 150 mg s.c. -

Placebo Comparator: 150 mg placebo -

Experimental: 300 mg s.c. -

Placebo Comparator: 300 mg placebo -

Experimental: 450 mg s.c. -

Placebo Comparator: 450 mg placebo -


Treatment: Drugs: HB0017
HB0017 at 100 mg/mL (1 mL/vial) in 2 mL glass vial with a rubber stopper. HB0017 will be administered in the abdominal area by a subcutaneous injection in the mornings. A maximum volume of 1 mL is injected per site.

Treatment: Drugs: placebo
A matching injection solution containing a specific volume of normal saline (0.9%, Sodium Chloride Injection USP) and no active substance will be prepared for the subjects who will be assigned to placebo according to the dose schedule.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Timepoint [1] 0 0
113Days.
Secondary outcome [1] 0 0
AUC (Area Under Curve) after single dose
Timepoint [1] 0 0
1month
Secondary outcome [2] 0 0
T1/2 (Elimination Half-life) after single dose
Timepoint [2] 0 0
1month
Secondary outcome [3] 0 0
Cmax (Maximum Serum Concentration) after single dose
Timepoint [3] 0 0
1 month

Eligibility
Key inclusion criteria
-

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

1. Healthy male or female subjects age = 18 and = 55 years.

2. 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.

3. 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;

4. Body Mass Index (BMI) = 18.5 and = 30 kg/m².

5. No clinically significant findings in the medical history and physical examination.

6. No clinically significant laboratory values (including urinalysis), unless the
investigator considers any abnormality to not be clinically significant.

7. Normal ECG, blood pressure, respiratory rate, temperature and heart rate, unless the
investigator considers any abnormality to be not clinically significant.

8. Informed consent must be obtained in writing for all subjects enrolled into the study.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-

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

1. History of clinically significant cardiovascular, respiratory, hepatic, renal,
gastrointestinal, endocrine, hematological, psychiatric or neurological disease.

2. Current or history of malignancy (subjects with squamous cell skin cancer maybe
included based on investigator assessment.).

3. Family history of premature Coronary Heart Disease (CHD).

4. 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.

5. Participation in another research with any investigational product within 28 days or 5
half-lives of the drug, whichever is greater, before screening.

6. Any medical history of asthma, allergic rhinitis or urticarial, or any other
clinically significant allergy reaction including food allergy. Known allergy to
biologics.

7. 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.

8. Had a vaccination with a live attenuated vaccine within 6 months prior to dosing.

9. 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.

10. Positive test for hepatitis B, hepatitis C, or HIV at screening.

11. History of clinically significant opportunistic infection (e.g., invasive candidiasis
or pneumocystis pneumonia).

12. Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g.,
septicemia) within 3 months prior to screening.

13. 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.

14. 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.

15. 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.

16. Current cigarette smoker (cigarettes or e-cigarettes) who smoke over 5 cigarettes per
day within 3 months prior to screening.

17. Mental condition rendering the subject incapable of understanding the nature, scope,
and possible consequences of the study.

18. Pregnant or Breasting feeding subject. Positive pregnancy test (HCG) within 3 days
prior to Day 1.

19. Adults under guardianship and people with restriction of freedom by administrative and
legal decisions.

20. 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.

21. 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2021
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Huabo Biopharm Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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, 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04505033
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries