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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/NCT05385575




Registration number
NCT05385575
Ethics application status
Date submitted
18/05/2022
Date registered
23/05/2022
Date last updated
13/05/2024

Titles & IDs
Public title
A Study to Evaluate Effects of KN056 in Healthy Participants
Scientific title
A Randomized, Double-blind and Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN056 in Healthy Participants
Secondary ID [1] 0 0
KN056-A-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - KN056 (0.1mg)
Treatment: Drugs - KN056 (0.3mg)
Treatment: Drugs - KN056 (1.0mg)
Treatment: Drugs - KN056 (3.0mg)
Treatment: Drugs - KN056 (6.0mg)
Treatment: Drugs - KN056 (12.0mg)
Treatment: Drugs - KN056 (18.0mg)

Experimental: Cohort 1 - Participant will receive 0.1mg of single dose by subcutaneous injection of KN056

Experimental: Cohort 2 - Participant will receive 0.3mg of single dose by subcutaneous injection of KN056

Experimental: Cohort 3 - Participant will receive 1.0mg of single dose by subcutaneous injection of KN056 or placebo

Experimental: Cohort 4 - Participant will receive 3.0mg single subcutaneous dose of KN056 or placebo

Experimental: Cohort 5 - Participant will receive 6.0mg of single dose by subcutaneous injection of KN056 or placebo

Experimental: Cohort 6 - Participant will receive 12.0mg of single dose by subcutaneous injection of KN056 or placebo

Experimental: Cohort 7 - Participant will receive 18.0mg of single dose by subcutaneous injection of KN056 or placebo


Treatment: Drugs: KN056 (0.1mg)
The participants will receive assigned single dose of KN056 on Day 1

Treatment: Drugs: KN056 (0.3mg)
The participants will receive assigned single dose of KN056 on Day 1

Treatment: Drugs: KN056 (1.0mg)
The participants will receive assigned single dose of KN056 or placebo on Day 1

Treatment: Drugs: KN056 (3.0mg)
The participants will receive assigned single dose of KN056 or placebo on Day 1

Treatment: Drugs: KN056 (6.0mg)
The participants will receive assigned single dose of KN056 or placebo on Day 1

Treatment: Drugs: KN056 (12.0mg)
The participants will receive assigned single dose of KN056 or placebo on Day 1

Treatment: Drugs: KN056 (18.0mg)
The participants will receive assigned single dose of KN056 or placebo on Day 1
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of treatment-emergent adverse events (TEAEs) and treatment related (TRAEs). TEAEs will be measured as per the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0.
Timepoint [1] 0 0
Up to 45 days
Primary outcome [2] 0 0
Severity of TEAEs and treatment related TEAEs. TEAEs will be measured as per the Common Terminology Criteria for (CTCAE) v5.0
Timepoint [2] 0 0
Up to 45 days
Primary outcome [3] 0 0
Number of participants with abnormal clinically significant laboratory results.
Timepoint [3] 0 0
Up to 45 days
Primary outcome [4] 0 0
Number of participants with abnormal clinically significant vital signs.
Timepoint [4] 0 0
Up to 45 days
Primary outcome [5] 0 0
Number of participants with abnormal clinically significant electrocardiogram (ECG)
Timepoint [5] 0 0
Up to 45 days
Secondary outcome [1] 0 0
To evaluate the pharmacokinetic parameters of KN056. Pharmacokinetic parameters will be estimated using non-compartment model analysis with Phoenix WinNolin 8.0
Timepoint [1] 0 0
Day 1, Day 7, Day 14, Day 21, Day 28, Day 42
Secondary outcome [2] 0 0
Immunogenicity of KN056
Timepoint [2] 0 0
Up to 45 days
Secondary outcome [3] 0 0
The efficacy of KN056 by analyzing fasting blood glucose
Timepoint [3] 0 0
Up to 45 days
Secondary outcome [4] 0 0
The efficacy of KN056 through Oral Glucose Tolerance test (OGTT)
Timepoint [4] 0 0
Up to 45 days
Secondary outcome [5] 0 0
The efficacy of KN056 by analyzing HbA1c (Glycosylated hemoglobin) changes
Timepoint [5] 0 0
Up to 45 days

Eligibility
Key inclusion criteria
1. Healthy male or female subjects (not be breastfeeding);

2. Aged between 18 and 55 (including thresholds) at the time of signing Informed Consent
Form;

3. Body mass index (BMI) between 18.5 and 35.0 kg/m2 (excluding the threshold);

4. 3.5mmol/L(63 mg/dL) less than or equal to Fasting blood glucose level less than
6.1mmol/L(110 mg/dL).

5. Are reliable and willing to make themselves available for the duration of the study
and are willing to follow study procedures and are willing to follow study
restrictions;

6. Are able and willing to sign the ICF.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Those who have a history of chronic diseases or are currently suffering from obvious
systemic diseases, such as diseases of cardiovascular system, respiratory system,
endocrine and metabolic system, urinary system, digestive system, blood system,
autoimmune system, neurological or psychiatric system, bacterial or viral infection;

2. History or presence of pancreatitis (history of chronic pancreatitis or idiopathic
acute pancreatitis)

3. History of GI disorder (for example, relevant esophageal reflux or gall bladder
disease) or any GI disease which impacts gastric emptying (for example, gastric bypass
surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated
by GLP-1 analogs or DPP-IV inhibitors;

4. Participants with dyslipidemia (Total Cholesterol more than 6mmol/L and/or
Triglyceride more than or equal to 1.7 mmol/L);

5. Participants had cholecystolithiasis (removal of gallstones) and/or cholecystectomy
(removal of gall bladder) in the past;

6. A personal or family history of medullary thyroid cancer or multiple endocrine adenoma
syndrome type 2 (MEN2);

7. Allergies to GLP-1 analogues, or KN056 related compounds;

8. A history of medicine abuse/dependence or narcotics abuse within 1 year prior to the
screening and/or show positive findings on urinary drug screening;

9. Previous alcoholism or have regular alcohol consumption (drinking more than 14 units
of alcohol per week in the 3 months prior to the screening, are unwilling to stop
alcohol consumption from at least 48 hours before landing in Phase I ward (D-2) to the
end of discharge from the clinical research unit (CRU), or are unwilling to limit
intake to a maximum of 2 units per day on all other days from screening through
follow-up (1 unit =12oz or 360 mL of beer; 5oz or 150 mL of wine; 1.5oz or 45 mL of
distilled spirits);

10. Smokers who have smoked more than 10 cigarettes or equivalent in nicotine
(e-cigarettes/vaping) daily within 3 months prior to screening or are unwilling to
refrain from smoking on the day of drug administration or are unable to abide by
clinical research unit (CRU) restrictions;

11. Blood donation or blood loss = 300 mL within 3 months prior to screening (except
female physical blood loss), or blood/blood components donation planned during the
trial or within 1 month after the final study visit;

12. Those who participated in any drug/vaccine clinical trial, and the last administration
of the trial was within 3 months or 5 half-lives of the drug/vaccine prior to dosing
of study drug, whichever is longer;

13. Received vaccination within 14 days prior to screening, or have vaccination schedule
during the trial (from screening to the final visit), including inactivated vaccine,
live attenuated vaccine, recombinant protein vaccine, recombinant adenovirus vaccine,
RNA vaccine, DNA vaccine, COVID-19 vaccine;

14. Use medication (including prescription drugs, over-the-counter drugs, herbal medicine)
with the exception of vitamin/mineral supplements, paracetamol, topical medication,
and contraceptives within 14 days prior to dosing;

15. Have abnormal and clinically significant results of physical examination, vital signs,
abdominal B-ultrasonography (liver, gallbladder, pancreas, spleen and kidneys) or
thyroid B-ultrasonography, and may increases the risks associated with participating
in the study;

16. Have abnormal and clinically significant results of Hematology, Urinalysis, blood
biochemistry, serum lipase, calcitonin, thyroid function and glycosylated hemoglobin
(HbA1c>40mmol/mol (5.8%)) and may increases the risks of participants in the study;

17. ECG shows increased heart rate (>100 beats/min), arrhythmia, significant QT/QTc
interval prolongation (QTcF (Frederica values) >450ms for males and > 470ms for
females) and other manifestations, which are clinically significant;

18. Evidence of hepatitis B or positive hepatitis B surface antigen at screening; evidence
of hepatitis C or hepatitis C antibody at screening; evidence of AIDS and/or positive
HIV antibodies at screening; evidence of syphilis and/or syphilis test is positive at
screening;

19. The result of coronavirus nucleic acid test (COVID-19) is positive at screening or
admission (Day-2)

20. Participants that refuse to stay abstinent, and refuse to consistently use a form of
highly effective birth control in combination with a barrier method if heterosexually
active starting at Screening (signing the ICF) and continuing throughout the clinical
study period, and to 3 months after administration of KN056 or Placebo, or
participants tell that their partners refuse to do so;

Examples of highly effective forms of contraception include:

- Implant contraceptive (e.g. Jadelle®)

- Intra-uterine device (IUD) containing either copper or levonorgestrel (e.g.
Mirena®)

- Male sterilization (vasectomy)

- Female sterilization (e.g. bilateral tubal ligation ('clipping or tying tubes')
or hysterectomy)

- Injectable contraceptive (e.g. Depo Provera)

- Oral Contraceptive Pill (combined hormonal contraceptive pill or progestogen-only
'mini-pill')

These requirements do not apply to female participants in a same sex relationship and
female participants of nonchildbearing potential.

Female participants of nonchildbearing potential should meet one of the following
conditions:

- Must have a confirmed clinical history of sterility (documented hysterectomy,
bilateral salpingectomy, or bilateral oophorectomy, as confirmed by review of the
subjects' medical records, medical examination, or medical history interview)

- Must be postmenopausal as defined as: amenorrhea for = 12 months prior to
screening and a laboratory confirmed serum follicle-stimulating hormone (FSH)
level = 40 IU/L at screening.

21. Female participants of childbearing potential (no matter homosexuality or
heterosexuality) with positive pregnancy test at Screening and Day -1;

22. Participants that plan to donate sperms/eggs from dosing until 3 months after
administration of KN056 or Placebo;

23. Participants with any inappropriate factor for participation in this study considered
by the investigator or sponsor;

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 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
9/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/02/2024
Sample size
Target
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Suzhou Alphamab Co., Ltd.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 1, First-in-human, double-blinded, placebo-controlled study which aims to
investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the
immunogenicity of KN056 in healthy participants.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05385575
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alexandra Cole
Address 0 0
New Zealand Clinical Research
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