This was an open-label, multi-center, FIH study with a single ascending dose (SAD) design that assessed the safety, tolerability and pharmacokinetics (PK) of a single IVT dose of MHU650 in up to 24 participants with macular edema.
A total of up to 4 cohorts were planned to be enrolled, with an additional lower or intermediate cohort of participants. First to third generation Japanese participants could be enrolled in all cohorts but were not required to be enrolled. The screening period for this study will be up to 60 days. A single dose of MHU650 intravitreal injection will be administered at Baseline / Day 1 in the study eye. The follow up period will last until Day 60 / end of study (EOS). A post study safety phone contact call will occur 30 days after the EOS visit.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
MHU650 powder for solution for injection
Novartis Investigative Site
Huntington Beach, California, United States
Novartis Investigative Site
Honolulu, Hawaii, United States
Novartis Investigative Site
Hagerstown, Maryland, United States
Novartis Investigative Site
Austin, Texas, United States
Number of participants with ocular and nonocular adverse events
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.
Time frame: Day 1 to Day 60
Change from baseline in Best Correct Visual Acuity (BCVA ) by dose level and timepoint - Study Eye
Best Correct Visual Acuity was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.
Time frame: Day 1 to Day 60
Change from baseline in Central subfield thickness (CSFT) (µm) in the study eye by dose level and timepoint
Central subfield thickness was measured by spectral domain optical coherence tomography (SD-OCT).
Time frame: Day 1 to Day 60
Change from baseline in Intraocular pressure (IOP) (mmHg) in the study eye by dose level and timepoint
Intraocular pressure was measured per the sites' local standard operating procedures, via tonometry.
Time frame: Day 1 to Day 60
Pharmacokinetics of single dose of MHU650 - Cmax
Assess serum PK profile of MHU650 by Cmax (if feasibile)
Time frame: Days 1, 2, 5, 15, 29, 43 and 60
Pharmacokinetics of single dose of MHU650 - Tmax
Assess serum PK profile of MHU650 by Tmax (if feasibile)
Time frame: Days 1, 2, 5, 15, 29, 43 and 60
Pharmacokinetics of single dose of MHU650 - T1/2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Arecibo, Puerto Rico
Assess serum PK profile of MHU650 by T1/2 (if feasibile)
Time frame: Days 1, 2, 5, 15, 29, 43 and 60
Pharmacokinetics of single dose of MHU650 - AUClast
Assess serum PK profile of MHU650 by AUClast (if feasibile)
Time frame: Days 1, 2, 5, 15, 29, 43 and 60
Pharmacokinetics of single dose of MHU650 - AUCinf
Assess serum PK profile of MHU650 by AUCinf (if feasibile)
Time frame: Days 1, 2, 5, 15, 29, 43 and 60