CompletedPhase 1

Safety and Tolerability of NTX-101 in Korean Healthy Volunteers

South Korea36 participantsStarted 2021-03-02

Plain-language summary

A double-blinded, placebo controlled, multiple dose, randomized, single site, phase 1 clinical trial to evaluate safety, tolerability, and pharmacokinetics of NTX-101 topical eye drop in Korean healthy volunteers

Who can participate

Age range19 Years – 45 Years

SexALL

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Inclusion criteria

✓. Healthy adult subjects who have voluntarily agreed to the participation of this study upon sufficient explanation of the purpose, procedure, and the characteristics of the experimental drug of the trial prior to participation
✓. Subjects of ages between 19 and 45 years inclusive and with Body Mass Index (BMI) between 18.0 and 27.0

Exclusion criteria

✕. Clinical History
✕. Ocular History
✕. Clinical Examination
✕. AST or ALT \>1.25 x upper limit of normal level
✕. Total bilirubin \>1.5 x upper limit of normal
✕. eGFR level from CKD-EPI equation \< 90 mL/min/1.73m²
✕. Positive blood serum result (HBsAg, HCV Ab, HIV Ab, Syphilis reagin test)
✕. PR interval ≥ 210msec

What they're measuring

Safety Evaluation: Incidence, type, and severity of Adverse Events (AE)

Timeframe: 7 Days

Trial details

NCT IDNCT05041543

SponsorPinotbio, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-15

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