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Clinical Trial Details

Trial ID: L6133
Source ID: NCT05385575
Associated Drug: Kn056 (0.1mg)
Title: A Study to Evaluate Effects of KN056 in Healthy Participants
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: KN056 (0.1mg)|DRUG: KN056 (0.3mg)|DRUG: KN056 (1.0mg)|DRUG: KN056 (3.0mg)|DRUG: KN056 (6.0mg)|DRUG: KN056 (12.0mg)|DRUG: KN056 (18.0mg)
Outcome Measures: Primary: 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: To evaluate the pharmacokinetic parameters of KN056. Pharmacokinetic parameters will be estimated using non-compartment model analysis with Phoenix WinNolin 8.0, Parameters: AUC0-last, AUC0-inf, MRT, Tmax, Cmax or above and T1/2, CL/F, Vz/F and so on., Day 1, Day 7, Day 14, Day 21, Day 28, Day 42|Immunogenicity of KN056, The immunogenicity of KN056 will be evaluated by detection of ADA, and ADA titer and NAb will be detected in ADA positive samples, 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
Sponsor/Collaborators: Sponsor: Suzhou Alphamab Co., Ltd. | Collaborators: Novotech (Australia) Pty Limited
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 46
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-08-09
Completion Date: 2024-02-29
Results First Posted:
Last Update Posted: 2024-12-30
Locations: Alexandra Cole, Christchurch, 8011, New Zealand
URL: https://clinicaltrials.gov/show/NCT05385575