A Study to Evaluate Features of KN069 in Participants With Obesity or Overweight
ConditionOverweight or Obesity
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-55
SponsorSuzhou Alphamab Co., Ltd.
About this trial
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
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- KN069
Treatment groups
36 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov