A Phase 1 interventional study of Single dose of rhEGF 10mcg/ml or placebo and Single dose of rhEGF 50mcg/ml or placebo in Dry Eye Syndromes, sponsored by Daewoong Bio Inc.. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 51 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-02.
Sponsored by Daewoong Bio Inc. · Phase 1, Interventional, and Screening
A randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of the Pharmacokinetics, safety, and tolerability of rhEGF eye drops in healthy male subjects
Primary Objective: To evaluate safety and tolerability of rhEGF eye drop/ Secondary Objective: To evaluate PK of rhEGF eye drop
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 48 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Daewoong Bio Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
single dose of rhEGF 10mcg/mL eye drop or single dose of placebo \*single dose means daily dose (administration twice daily)
Drug: Single dose of rhEGF 10mcg/ml or placebo
single dose of rhEGF 50mcg/mL eye drop or single dose of placebo \*single dose means daily dose (administration twice daily)
Drug: Single dose of rhEGF 50mcg/ml or placebo
single dose of rhEGF 100mcg/mL eye drop or single dose of placebo \*single dose means daily dose (administration twice daily)
Drug: Single dose of rhEGF 100mcg/ml or placebo
multiple dose of rhEGF 10mcg/mL eye drop or multiple dose of placebo
Drug: Multiple dose of rhEGF 10mcg/ml or placebo
multiple dose of rhEGF 50mcg/mL eye drop or multiple dose of placebo
Drug: Multiple dose of rhEGF 50mcg/ml or placebo
multiple dose of rhEGF 100mcg/mL eye drop or multiple dose of placebo
Drug: Multiple dose of rhEGF 100mcg/ml or placebo
6 subjects will be assigned to rhEGF 10mcg/ml eye drop and 2 subjects will be assigned to placebo
6 subjects will be assigned to rhEGF 50mcg/ml eye drop and 2 subjects will be assigned to placebo
6 subjects will be assigned to rhEGF 100mcg/ml eye drop and 2 subjects will be assigned to placebo
6 subjects will be assigned to rhEGF 10mcg/ml eye drop and 2 subjects will be assigned to placebo
6 subjects will be assigned to rhEGF 50mcg/ml eye drop and 2 subjects will be assigned to placebo
6 subjects will be assigned to rhEGF 100mcg/ml eye drop and 2 subjects will be assigned to placebo
Incidence of treatment emergent adverse events
* sign and symptoms of AE * physical exam, vital signs, ECG exam, lab test * ophthalmic exam: schirmer's test, TBUT test, slit lamp exam etc * Immunogenicity test (anti-drug antibody)
Time frame: 14 days from baseline
PK characteristics
Cmax in single dose administration period
Time frame: 14 days from baseline
PK characteristics
AUC in single dose administration period
Time frame: 14 days from baseline
PK characteristics
Cmax in multiple dose adminitration period
Time frame: 14 days from baseline
PK characteristics
AUC in multiple dose administration period
Time frame: 14 days from baseline
PK characteristics
Cav in multiple dose administration period
Time frame: 14 days from baseline
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Daewoong Bio Inc.