A Clinical trial to study to evaluate effect of compound 1334 H ophthalmic solution in healthy subjects

A RANDOMIZED, DOUBLE-MASKED, PLACEBO-CONTROLLED, PARALLEL-GROUPS, SINGLE DAY, DOSE ESCALATION STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF COMPOUND 1334H OPHTHALMIC SOLUTION IN HEALTHY SUBJECTS

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/002953

Enrollment

Registered

2010-11-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Compound 1334H: dose escalation study Control Intervention1: Placebo: Placebo matchin intervention compound 1334H

Eligibility

Inclusion criteria

Inclusion criteria: Healthy male and female subjects, 18 to 45 years of age, subjects having weight at least 50Kg and the subjects body mass index (BMI) must be within 18.5 ? 25.0 (Kg/m2) (inclusive),Corrected Snellen visual acuity > 20/25 in both eyes,Intraocular pressure (IOP) completion,Willing to comply with scheduled visits, treatment plans, laboratory assessments and other study-related procedures,Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), oral or long acting injected contraceptives] from at least 2 months prior to study entry and through the duration of the study; or postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject); with a negative urine pregnancy test,Provide written informed consent to participate.

Exclusion criteria

Exclusion criteria: History of ocular surgery, trauma, or chronic ocular disease,Current use of contact lenses or discontinuation of contact lens use less than 2 weeks of the first dosing day,Any ocular abnormalities or ocular symptoms,Use of ocular agents (including eye drops) within the past 2 months or anticipated use of ocular agents during the study period,Alcohol dependence, alcohol abuse or drug abuse with any recreational drug within past one year,Smoking or consumption of tobacco products,Use of enzyme-modifying drugs in the previous 30 days before day 1 of this study,Systemic corticosteroid use within the past 6 months.

Design outcomes

Primary

Measure	Time frame
Physical examination, vital signs measurement, clinical laboratory evaluation, ECG, slit lamp biomicroscopy, dilated fundoscopy, snellen visual acuity, evaluation of ocular comfort, adverse event and serious adverse event evaluation. PK parametersTimepoint: Screening, check-in, in-study, check-out, post-study	—

Secondary

Measure	Time frame
NATimepoint: NA	—

Countries

India

Contacts

Public ContactDr Mudgal Kothekar MD

Sun Pharma Advanced Research Company Limited

Clinical.Trials@sparcmail.com912266455645

Outcome results