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Clinical Trial Details

Trial ID: L5361
Source ID: NCT05272059
Associated Drug: Mhs552
Title: Multiple Ascending Dose Study of MHS552 in Adults With Type 1 Diabetes Mellitus
Acronym:
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: MHS552|DRUG: Placebo
Outcome Measures: Primary: Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs), Numbers of participants with AEs and SAEs including vital signs, electrocardiograms (ECG) and laboratory results, Part A: up to 12 weeks; Part B: up to 20 weeks | Secondary: Area Under Plasma Concentration-time Curve calculated to the end of a dosing interval (AUCtau) for MHS552, Characterize the AUCtau profile following multiple doses of MHS552, Part A: up to Day 78; Part B: up to Day 134|Maximum ObservBlood Concentrations (Cmax) for MHS552, Characterize the Cmax profile following multiple doses of MHS552, Part A: up to Day 78; Part B: up to Day 134|Time to Reach Maximum Blood Concentrations (Tmax) of MHS552, Characterize the Tmax profile following multiple doses of MHS552, Part A: up to Day 78; Part B: up to Day 134
Sponsor/Collaborators: Sponsor: Novartis Pharmaceuticals
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-09-01
Completion Date: 2025-04-14
Results First Posted:
Last Update Posted: 2023-04-07
Locations:
URL: https://clinicaltrials.gov/show/NCT05272059