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LNZ100

Phase 1

Presbyopia | Small molecule | Ophthalmology |Milestone Pharmaceuticals Inc.|Last Updated: Apr 23, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

LNZ100 · 1 trial · 1 indication

Phase 1 1
NCT06270030Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Chinese With PresbyopiaPresbyopia
COMPLETED21 Analytics
PHASE1COMPLETED
Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Chinese With Presbyopia
PresbyopiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Cmax
Day 1 and Day 8

Maximum plasma concentrations of LNZ100 and LNZ101

Tmax
Day 1 and Day 8

Time of maximum plasma concentrations of LNZ100 and LNZ101

AUC0-t
Day 1 and Day 8

Area under the concentration-time curve from time 0 to time t of LNZ100 and LNZ100

AUC0-∞
Day 1 and Day 8

Area under the concentration-time curve from time 0 to infinity of LNZ100 and LNZ101

T1/2
Day 1 and Day 8

Terminal half-life of LNZ100 and LNZ101

Safety: adverse event reporting
up to 23 days

The number of patients who experience one or more AE during the treatment period

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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LNZ101 (Aceclidine /Brimonidine) ophthalmic solutionEXPERIMENTALDrug: Aceclidine/Brimonidine ophthalmic solution Other Names: LNZ101
LNZ100 (Aceclidine) ophthalmic solutionEXPERIMENTALDrug: Aceclidine ophthalmic solution Other Names: LNZ100
Placebo (Vehicle) ophthalmic solutionPLACEBO_COMPARATORDrug: Placebo (Vehicle) ophthalmic solution Other Names: NA

Interventions

NameTypeDescription
LNZ101 (Aceclidine /Brimonidine) ophthalmic solutionDRUGOnce daily from day 1 to day 8; Everyday, subject will be administered with 1 drop in each eye followed by another drop in each eye 2 minutes later
LNZ100 (Aceclidine) ophthalmic solutionDRUGOnce daily from day 1 to day 8; Everyday, subject will be administered with 1 drop in each eye followed by another drop in each eye 2 minutes later
Placebo (Vehicle) ophthalmic solutionDRUGOnce daily from day 1 to day 8; Everyday, subject will be administered with 1 drop in each eye followed by another drop in each eye 2 minutes later
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Eligibility Criteria

Age Range45 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria 1. Be able and willing to provide written informed consent prior to any study procedure being performed. 2. Be able to and willing to use investigational products per study requirements and attend all study assessments, including admission to and stay in the CRU on required study...

Countries:China
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Frequently asked questions about LNZ100

What is LNZ100 used for?

LNZ100 is an investigational small molecule being developed for presbyopia, an age-related eye condition that reduces the eye's ability to focus on close objects. It is formulated as an ophthalmic solution, meaning it is applied directly to the eye. The drug is currently in clinical development and has not been approved by regulatory authorities.

Who makes LNZ100?

LNZ100 is being developed by Milestone Pharmaceuticals Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol MIST. The company is conducting clinical trials to evaluate the safety and tolerability of the drug in patients with presbyopia.

What phase is LNZ100 in?

LNZ100 is in Phase 1 clinical development. A Phase 1 trial has been completed, which focused on evaluating the safety, tolerability, and pharmacokinetics of the drug. The drug is still investigational and has not received approval from regulatory agencies for commercial use.

What clinical trials is LNZ100 in?

LNZ100 has been studied in one completed Phase 1 clinical trial, identified as NCT06270030. This trial enrolled 21 healthy adult participants in China and assessed the safety, tolerability, and pharmacokinetics of LNZ100 ophthalmic solutions in individuals with presbyopia.

Is LNZ100 the same as LNZ101?

LNZ100 and LNZ101 are distinct investigational drugs, though they were both evaluated in the same clinical trial, NCT06270030. That trial assessed the safety, tolerability, and pharmacokinetics of both LNZ101 and LNZ100 ophthalmic solutions in healthy adults with presbyopia. They are separate formulations being developed by the same company.