A Study to Evaluate Effects of KN056 in Healthy Participants

NCT05385575 | Completed Phase 1 DMC

• 1 other identifier: KN056-A-101
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (5)

• 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.

  Up to 45 days

• Severity of TEAEs and treatment related TEAEs. TEAEs will be measured as per the Common Terminology Criteria for (CTCAE) v5.0

  Up to 45 days

• Number of participants with abnormal clinically significant laboratory results.

  Clinical laboratory includes hematology, biochemistry, lipase, calcitonin, thyroid function, Abdominal and thyroid B-ultrasonography, and urinalysis.

  Up to 45 days

• Number of participants with abnormal clinically significant vital signs.

  Vital signs include Includes blood pressure (systolic and diastolic), respiration, temperature and pulse.

  Up to 45 days

• Number of participants with abnormal clinically significant electrocardiogram (ECG)

  12-lead ECG will be performed.

  Up to 45 days

Secondary Outcomes (5)

• To evaluate the pharmacokinetic parameters of KN056. Pharmacokinetic parameters will be estimated using non-compartment model analysis with Phoenix WinNolin 8.0

  Day 1, Day 7, Day 14, Day 21, Day 28, Day 42

• Immunogenicity of KN056

  Up to 45 days

• The efficacy of KN056 by analyzing fasting blood glucose

  Up to 45 days

• The efficacy of KN056 through Oral Glucose Tolerance test (OGTT)

  Up to 45 days

• The efficacy of KN056 by analyzing HbA1c (Glycosylated hemoglobin) changes

  Up to 45 days

Study Arms (7)

Cohort 1

EXPERIMENTAL

Participant will receive 0.1mg of single dose by subcutaneous injection of KN056

Drug: KN056 (0.1mg)

Cohort 2

EXPERIMENTAL

Participant will receive 0.3mg of single dose by subcutaneous injection of KN056

Drug: KN056 (0.3mg)

Cohort 3

EXPERIMENTAL

Participant will receive 1.0mg of single dose by subcutaneous injection of KN056 or placebo

Drug: KN056 (1.0mg)

Cohort 4

EXPERIMENTAL

Participant will receive 3.0mg single subcutaneous dose of KN056 or placebo

Drug: KN056 (3.0mg)

Cohort 5

EXPERIMENTAL

Participant will receive 6.0mg of single dose by subcutaneous injection of KN056 or placebo

Drug: KN056 (6.0mg)

Cohort 6

EXPERIMENTAL

Participant will receive 12.0mg of single dose by subcutaneous injection of KN056 or placebo

Drug: KN056 (12.0mg)

Cohort 7

EXPERIMENTAL

Participant will receive 18.0mg of single dose by subcutaneous injection of KN056 or placebo

Drug: KN056 (18.0mg)

Interventions

KN056 (0.1mg) DRUG

The participants will receive assigned single dose of KN056 on Day 1

Cohort 1

KN056 (0.3mg) DRUG

The participants will receive assigned single dose of KN056 on Day 1

Cohort 2

KN056 (1.0mg) DRUG

The participants will receive assigned single dose of KN056 or placebo on Day 1

Cohort 3

KN056 (3.0mg) DRUG

The participants will receive assigned single dose of KN056 or placebo on Day 1

Cohort 4

KN056 (6.0mg) DRUG

The participants will receive assigned single dose of KN056 or placebo on Day 1

Cohort 5

KN056 (12.0mg) DRUG

The participants will receive assigned single dose of KN056 or placebo on Day 1

Cohort 6

KN056 (18.0mg) DRUG

The participants will receive assigned single dose of KN056 or placebo on Day 1

Cohort 7

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects (not be breastfeeding);
• Aged between 18 and 55 (including thresholds) at the time of signing Informed Consent Form;
• Body mass index (BMI) between 18.5 and 35.0 kg/m2 (excluding the threshold);
• mmol/L(63 mg/dL) less than or equal to Fasting blood glucose level less than 6.1mmol/L(110 mg/dL).
• 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;
• Are able and willing to sign the ICF.

You may not qualify if:

• 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;
• History or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis)
• 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;
• Participants with dyslipidemia (Total Cholesterol more than 6mmol/L and/or Triglyceride more than or equal to 1.7 mmol/L);
• Participants had cholecystolithiasis (removal of gallstones) and/or cholecystectomy (removal of gall bladder) in the past;
• A personal or family history of medullary thyroid cancer or multiple endocrine adenoma syndrome type 2 (MEN2);
• Allergies to GLP-1 analogues, or KN056 related compounds;
• 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;
• 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);
• 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;
• 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;
• 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;
• 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;
• 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;
• 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;

Sponsors & Collaborators

• Suzhou Alphamab Co., Ltd.: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (1)

Alexandra Cole

Christchurch, Christchurch, 8011, New Zealand

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Alexandra Cole

  New Zealand Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 23, 2022
• Study Start: August 9, 2022
• Primary Completion: December 22, 2023
• Study Completion: February 29, 2024
• Last Updated: December 30, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)