Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With wAMD, DME and RVO

NCT03790852 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2024-03-20

No results posted yet for this study

Summary

This is a Phase 1b open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of repeated injections of KSI-301 at two dose levels: 2.5 mg and 5 mg

Conditions

Interventions

DRUG

KSI-301

Intravitreal injection

Sponsors & Collaborators

  • Kodiak Sciences Inc

    lead INDUSTRY

Principal Investigators

  • Pablo Velazquez-Martin, MD · Kodiak Sciences Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-26
Primary Completion
2021-06-02
Completion
2022-06-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03790852 on ClinicalTrials.gov