A Study to Evaluate Features of KN069 in Participants With Obesity or Overweight

Last updated: September 3, 2024
Sponsor: Suzhou Alphamab Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

KN069

Clinical Study ID

NCT06547775
KN069-A-101
  • Ages 18-55
  • Male
  • Accepts Healthy Volunteers

Study 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 KN069 in Chinese male participants with Obesity or Overweight.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male, 18-55 years old (including threshold);

  2. Body mass index (BMI):24.0 kg/m2≤BMI<35 kg/m2;

  3. HbA1c<6.5%;3.9mmol/L≤Fasting blood glucose level <7.0mmol/L;

  4. Are reliable and willing to make themselves available for the duration of the studyand are willing to follow study procedures and are willing to follow studyrestrictions; Are able and willing to sign the ICF.

Exclusion

Exclusion Criteria:

  1. Those who have a history of chronic diseases or are currently suffering from obvioussystemic 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 of acute or chronic pancreatitis; A personal or family history of medullarythyroid cancer or multiple endocrine adenoma syndrome type 2; A history of othermalignancies;

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

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

  5. Allergies to KN069 excipients or drugs similar to KN069 in structure or KN069 in thesame category;

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

  7. Have undergone any major surgery or surgery affecting drug absorption, distribution,metabolism, excretion within the 3 months prior to screening, or are scheduled toundergo surgery during the trial period (major surgery is defined as surgery on theintracranial, chest, abdomen, pelvic, or limb organs that result in major tissuetrauma and require long-term recovery).

  8. Drinking more than 14 units of alcohol per week (1 unit =360ml beer or 45ml liquorwith 40% alcohol or 150ml wine) in the 3 months before or during the screeningperiod, alcohol cannot be banned during the hospital stay, and alcohol consumptioncannot be limited to less than 2 units of alcohol per day during the post-dischargevisit.

  9. Blood donation or blood loss ≥ 300 mL within 3 months prior to screening, orblood/blood components donation planned during the trial or within 1 month after thefinal study visit.

  10. Received administration of other drugs/vaccines in clinical trials within 2 monthsprior to screening; In other clinical trials at the time of screening;

  11. People who diet or undergo weight loss treatment within 2 months (for whateverreason) before administration, or who have made significant changes in theirlifestyle habits.;

  12. Received vaccination within 14 days prior to screening, or have vaccination scheduleduring the trial, including inactivated vaccine, live attenuated vaccine,recombinant protein vaccine, recombinant adenovirus vaccine, RNA vaccine, DNAvaccine, COVID-19 vaccine;

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

  14. Use of GLP-1 analogues, GLP-1 receptor agonists, or any other formulations relatedto incretin and other drugs that the investigator believes may affect the trialwithin the 3 months prior to administration.

  15. Any abnormal patients who met the following criteria during screening: 1) serumalanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkalinephosphatase (ALP) exceeded the upper limit of the reference value range by 2 times;Serum total bilirubin (TBIl) exceeded 1.5 times the upper limit of the referencevalue range; 2) Fasting triglyceride (TG) ≥5.6mmol/L; 3) Physical examination, vitalsigns, electrocardiogram, laboratory examination, imaging and other abnormalitieshave clinical significance, and the investigator judges that they may pose a majorrisk to the subjects or interfere with the evaluation of safety, PK or PD resultsand are not suitable to participate in the trial;

  16. Positive breath test for alcohol (>0 mg/100 mL);

  17. Evidence of hepatitis B/hepatitis C/HIV/syphilis.

  18. Urine screen positive for drug abuse.

  19. Participants that refuse to stay abstinent, and refuse to consistently use a form ofhighly effective birth control method starting at Screening (signing the ICF) andcontinuing throughout the clinical study period, and to 3 months afteradministration of IP; or to have a birth plan during the screening period until 3months after dosing;

  20. Participants that plan to donate sperms from dosing until 3 months afteradministration of IP.

  21. Due to trauma, surgery, allergies or skin lesions, the abdominal skin is notsuitable for subcutaneous injection.

  22. Other factors that the investigator considers unacceptable for participation in thestudy.

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: KN069
Phase: 1
Study Start date:
August 02, 2024
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan
    China

    Site Not Available

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