A Study to Evaluate Effects of KN056 in Healthy Subjects

• Status: Not yet recruiting
• Trial end date: 2023-07-08
• Target enrollment: 0
• Participant gender: All

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 immune response of KN056 in healthy participants.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Suzhou Alphamab Co., Ltd.
• Collaborator: Novotech (Australia) Pty Limited

Criteria

Inclusion Criteria:

1. Healthy male or female subjects;

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)≤Fasting blood glucose level <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.

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), elevation in serum amylase or lipase (above the upper limit of normal [ULN]);

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. Subjects with dyslipidemia (Total Cholesterol >6mmol/L and/or Triglyceride ≥1.7 mmol/L);

5. Subjects 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 4 months prior to screening;

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 pancreatic amylase and 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;

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

20. Subjects that refuse to use effective contraception from signing the ICF until 3 months after the administration of KN056 or Placebo, or subjects tell that their partners refuse to do so; Female subjects with positive pregnancy test;

Effective contraceptions includes:

• 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')

• Vaginal contraceptive ring (e.g. NuvaRing®)

• Male condoms

• Female condoms

• Female diaphragm ('cap')

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

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