Clinical Trials/NCT06547775

NCT06547775

Recruiting

Phase 1

A Randomized, Double-blind and Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN069 in Chinese Male Participants With Obesity or Overweight

Suzhou Alphamab Co., Ltd.1 site in 1 country36 target enrollmentAugust 2, 2024

ConditionsOverweight or Obesity

InterventionsKN069

Overview

Phase: Phase 1
Intervention: KN069
Conditions: Overweight or Obesity
Sponsor: Suzhou Alphamab Co., Ltd.
Enrollment: 36
Locations: 1
Primary Endpoint: Frequency and severity of adverse events
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 KN069 in Chinese male participants with Obesity or Overweight.

Registry

clinicaltrials.gov

Start Date

August 2, 2024

End Date

June 30, 2027

Last Updated

7 months ago

Study Type

Interventional

Study Design

Sequential

Sex

Male

Investigators

Sponsor

Suzhou Alphamab Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male, 18-55 years old (including threshold);
•Body mass index (BMI)：24.0 kg/m2≤BMI\<35 kg/m2；
•HbA1c\<6.5%；3.9mmol/L≤Fasting blood glucose level \<7.0mmol/L；
•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.

Exclusion Criteria

•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 of acute or chronic pancreatitis; A personal or family history of medullary thyroid cancer or multiple endocrine adenoma syndrome type 2; A history of other malignancies;
•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 had cholecystolithiasis (removal of gallstones) or cholecystectomy (removal of gall bladder) in the past;
•Allergies to KN069 excipients or drugs similar to KN069 in structure or KN069 in the same category;
•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;
•Have undergone any major surgery or surgery affecting drug absorption, distribution, metabolism, excretion within the 3 months prior to screening, or are scheduled to undergo surgery during the trial period (major surgery is defined as surgery on the intracranial, chest, abdomen, pelvic, or limb organs that result in major tissue trauma and require long-term recovery).
•Drinking more than 14 units of alcohol per week (1 unit =360ml beer or 45ml liquor with 40% alcohol or 150ml wine) in the 3 months before or during the screening period, alcohol cannot be banned during the hospital stay, and alcohol consumption cannot be limited to less than 2 units of alcohol per day during the post-discharge visit.
•Blood donation or blood loss ≥ 300 mL within 3 months prior to screening, or blood/blood components donation planned during the trial or within 1 month after the final study visit.
•Received administration of other drugs/vaccines in clinical trials within 2 months prior to screening; In other clinical trials at the time of screening;

Arms & Interventions

Group 1: KN069 Dose 1

Participants will receive a single SC KN069 12mg.

Intervention: KN069

Group 2: KN069 Dose 2

Participants will receive a single SC KN069 30mg.

Intervention: KN069

Group 3: KN069 Dose 3

Participants will receive a single SC KN069 60mg.

Intervention: KN069

Group 4: KN069 Dose 4

Participants will receive a single SC KN069 120mg.

Intervention: KN069

Group 5: KN069 Dose 5

Participants will receive a single SC KN069 240mg.

Intervention: KN069

Outcomes

Primary Outcomes

Frequency and severity of adverse events

Time Frame: Up to Day 42

Secondary Outcomes

To evaluate the Area under the plasma concentration versus time curve (AUC) of KN069(Up to Day 42)
To evaluate the plasma concentration of KN069(Up to Day 42)
To evaluate the weight (kg) change from baseline(Up to Day 42)
To evaluate the BMI (kg/m^2) change from baseline(Up to Day 42)
Number of Participants with Anti-KN069 Antibodies(Up to Day 42)
To evaluate the waist circumference (cm) change from baseline(Up to Day 42)