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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/NCT05310487




Registration number
NCT05310487
Ethics application status
Date submitted
23/03/2022
Date registered
5/04/2022
Date last updated
27/11/2023

Titles & IDs
Public title
Phase 1 Study of 162, a Novel Neutralizing Antibody Targeting Hepatitis B Surface Antigen, in Healthy Adult Subjects
Scientific title
A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics of 162 With a Single Ascending Dose in Healthy Adult Subjects
Secondary ID [1] 0 0
YST-162-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - 162
Other interventions - Placebo

Experimental: 162 - The dose-escalation stage will be conducted sequentially at 5 dose levels, which are 100 mg in the pre-test, and 200 mg, 400 mg, 800 mg and 1200 mg in the formal test. Two healthy adult subjects will be enrolled at 100 mg dose level and all given 162. At the start of each level with the exception of 100 mg level which there are only two subjects, two sentinel subjects will be randomized 1:1 to 162 or placebo. The remaining subjects will be randomized 5:1 to receive a single ascending dose of 162 or placebo.

Placebo Comparator: placebo - At the start of each level with the exception of 100 mg level which there are only two subjects, two sentinel subjects will be randomized 1:1 to 162 or placebo. The remaining subjects will be randomized 5:1 to receive a single ascending dose of 162 or placebo.


Other interventions: 162
The investigational product 162 is a novel neutralizing antibody targeting HBsAg, for the treatment of patients with chronic hepatitis B

Other interventions: Placebo
an intervention that appearance is the same as 162, but contains no active ingredients
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events
Timepoint [1] 0 0
Day 1-Day 28
Secondary outcome [1] 0 0
Peak Plasma Concentration (Cmax)
Timepoint [1] 0 0
Day 1-Day 28
Secondary outcome [2] 0 0
Area under the plasma concentration versus time curve from time 0 to the last test time(AUC last)
Timepoint [2] 0 0
Day 1-Day 28
Secondary outcome [3] 0 0
Area under the plasma concentration versus time curve from time 0 to infinity time(AUC 0-8)
Timepoint [3] 0 0
Day 1-Day 28
Secondary outcome [4] 0 0
Half life (t1/2)
Timepoint [4] 0 0
Day 1-Day 28
Secondary outcome [5] 0 0
Clearance (Cl)
Timepoint [5] 0 0
Day 1-Day 28
Secondary outcome [6] 0 0
Apparent volume of distribution (Vd)
Timepoint [6] 0 0
Day 1-Day 28
Secondary outcome [7] 0 0
Immunogenicity
Timepoint [7] 0 0
Day 1-Day 28

Eligibility
Key inclusion criteria
1. Volunteer to participate in the study, be able to understand the requirements of a
clinical study, and sign informed consent form.

2. Aged = 18 and = 55 years older, male and female.

3. Body weight = 50 kg for male, body weight = 45 kg for female, and body mass index
(BMI) scores between = 18 kg/m2 and = 32.0 kg/m2.

4. Vital signs, physical examination, laboratory tests and 12-lead ECG, etc. within
normal limits; or, with no clinically significant abnormalities as determined by the
investigator.

5. A male participant must agree to use adequate contraception from screening through at
least 12 weeks after the last dose of investigational product or placebo. Refer to
Section 5.5 for more information on highly effective methods of contraception.

6. Women of childbearing potential must have a negative pregnancy test prior to the
dosing administration, and agree to use adequate contraception from screening through
at least 12 weeks after the last dose of investigational product or placebo. A female
participant of non-childbearing potential will have had at least 12 continuous months
of natural (spontaneous) amenorrhoea, follicle stimulating hormone (FSH) level > 40
mIU/mL at screening, and an appropriate clinical profile (e.g., age appropriate,
history of vasomotor symptoms); or have had surgical bilateral oophorectomy,
hysterectomy or tubal ligation beyond 6 weeks prior to screening. Refer to Section 5.5
for more information on highly effective methods of contraception
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of anaphylaxis or clinically significant drug allergy or drug allergy
witnessed in previous studies with experimental drugs, or allergy to the active
ingredients or excipients of the investigational product.

2. History of allergic reactions to monoclonal antibodies or antibody fragments.

3. History or presence of infectious or non-infectious liver disease, including but not
limited to a history of alcoholic liver disease, non-alcoholic steatohepatitis, drug
or autoimmune liver disease.

4. History or presence of immune-mediated diseases, including but not limited to
idiopathic thrombocytopenic purpura, systemic lupus erythematosus, rheumatoid
arthritis.

5. History or presence of any chronic infectious condition, including but not limited to
tuberculosis or parasitic infections.

6. History of allogenic transplantation of organs, bone marrow or stem cell.

7. Active infection, or screening for infectious disease during the screening period
(HBsAg, hepatitis C virus antibody [HCV-Ab], human immunodeficiency virus antibody
[HIV-Ab], or syphilis antibody [TP-Ab]) is positive.

8. QTcF >450 msec on 3 consecutive ECG recordings conducted at screening or baseline.

9. Alanine transaminase (ALT) > 1.2 × ULN, aspartate aminotransferase (AST) > 1.2 × ULN
or total bilirubin > 1.2 × ULN.

10. Any other concomitant disease, condition or treatment that could interfere with the
conduct of the study or that would, in the opinion of the Investigator or Sponsor,
pose an unacceptable risk to the subject in the study or interfere with the
interpretation of study data.

11. Took any prescription drugs or over-the-counter drugs within 2 weeks prior to
investigational product or placebo administration, or took any drugs within 5
half-lives at the time of investigational product or placebo administration (whichever
is longer), but vitamins, supplements and topical corticosteroids will be permitted
within 2 weeks prior to investigational product or placebo administration; or, took
any herbal medicines within 30 days before investigational product or placebo
administration.

12. Those who have received live or attenuated vaccines (e.g., measles, mumps, rubella,
varicella, yellow fever, rabies, BCG, typhoid vaccine, etc.) within 4 weeks before
screening, or any covid-19 vaccine within 2 weeks before screening.

13. Those who donated plasma within 7 days prior to the dosing administration or donated
or lost blood 500 mL or more within 8 weeks prior to the dosing administration, or
plan to donate during the study or within 8 weeks after the end of the study.

14. Those who underwent surgery within 4 weeks before screening, or plan to undergo
surgery during the study.

15. Those who are participating in other clinical studies, or currently not participating
in a study and have been dosed in another clinical study in the past 4 weeks.

16. Pregnant or lactating women.

17. Those who are determined disqualified to join clinical studies by investigator for
other causes.

Study design
Purpose of the study
Treatment
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 analysing the results/data
Intervention assignment
Parallel
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
30/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/10/2023
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Yangshengtang Co., Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Syneos Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is the first in human study of 162, and the primary objective is to evaluate the safety
and tolerability of 162 with a single ascending dose in healthy adult subjects.

The dose-escalation stage will be conducted sequentially at 5 dose levels, which are 100 mg
in the pre-test, and 200 mg, 400 mg, 800 mg and 1200 mg in the formal test.

Two healthy adult subjects will be enrolled at 100 mg dose level and all given 162. Eight
healthy adult subjects will be enrolled at each remaining dose levels (200 mg, 400 mg, 800 mg
and 1200 mg), respectively.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05310487
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