Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of OC-01 in Adult Chinese With Dry Eye Disease

NCT05576415 | Completed Phase 1 FDA Drug

• 1 other identifier: JX03003
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the pharmacokinetics (PK) in adult Chinese subjects with dry eye disease (DED)1 after bilateral nasal spray administration of OC-01 (varenicline solution) Nasal Spray at a concentration of 0.6 mg/mL.

Conditions

Dry Eye Disease

Keywords

OC-01 (Varenicline Solution); Dry Eye Disease

Outcome Measures

Primary Outcomes (6)

• Cmax of varenicline after the first dosing at Visit 1 [Day 1] and after the last dosing at Visit 3 [Day 28], respectively.

  To evaluate the Cmax of varenicline in adult Chinese with dry eye disease (DED) after the first dosing at Visit 1 \[Day 1\] and after the last dosing at Visit 3 \[Day 28\], respectively.

  Visit 1 [Day 1]: From predose of the 1st dosing to 12 hours post-dose. Visit 3 [Day 28]: From predose of the last dosing to 120 hours post-dose.

• Tmax of varenicline after the first dosing at Visit 1 [Day 1] and after the last dosing at Visit 3 [Day 28], respectively.

  To evaluate the Tmax of varenicline in adult Chinese subjects with DED after the first dosing at Visit 1 \[Day 1\] and after the last dosing at Visit 3 \[Day 28\], respectively.

  Visit 1 [Day 1]: From predose of the 1st dosing to 12 hours post-dose. Visit 3 [Day 28]: From predose of the last dosing to 120 hours post-dose.

• AUCtau(Area under the concentration-time curve during a dosing interval) of varenicline after the first dosing at Visit 1 [Day 1] and after the last dosing at Visit 3 [Day 28], respectively.

  To evaluate the AUCtau of varenicline in adult Chinese subjects with DED after the first dosing at Visit 1 \[Day 1\] and after the last dosing at Visit 3 \[Day 28\], respectively.

  Visit 1 [Day 1]: From predose of the 1st dosing to 12 hours post-dose. Visit 3 [Day 28]: From predose of the last dosing to 120 hours post-dose.

• AUC0-last(Area under the concentration-time curve from time 0 to the time of the last measured non-zero concentration) of varenicline after the first dosing at Visit 1 [Day 1] and after the last dosing at Visit 3 [Day 28], respectively.

  To evaluate the AUC0-last of varenicline in adult Chinese subjects with DED after the first dosing at Visit 1 \[Day 1\] and after the last dosing at Visit 3 \[Day 28\], respectively.

  Visit 1 [Day 1]: From predose of the 1st dosing to 12 hours post-dose. Visit 3 [Day 28]: From predose of the last dosing to 120 hours post-dose.

• T1/2 of varenicline after the last dosing at Visit 3 [Day 28]

  To evaluate the T1/2 of varenicline after the last dosing at Visit 3 \[Day 28\] in adult Chinese subjects with DED.

  Visit 3 [Day 28]: From predose of the last dosing to 120 hours post-dose

• λz of varenicline after the last dosing at Visit 3 [Day 28]

  To evaluate the λz of varenicline after the last dosing at Visit 3 \[Day 28\] in adult Chinese subjects with DED.

  Visit 3 [Day 28]: From predose of the last dosing to 120 hours post-dose

Secondary Outcomes (2)

• Change from baseline in Schirmer's Test Score (STS) at Visit 1 [Day 1], Visit 2 [Day 14] and Visit 3 [Day 28]

  From Day 1 to Day 28

• Change from baseline in Eye Dryness Score (EDS) at Visit 2 [Day 14] and Visit 3 [Day 28]

  From Day 14 to Day 28

Study Arms (1)

OC-01

EXPERIMENTAL

Drug: Varenicline Tartrate Nasal Spray

Interventions

Varenicline Tartrate Nasal Spray DRUG

Intranasal delivery of OC-01 (varenicline solution) 0.6 mg/mL twice a day (BID) for 28 days.

Also known as: OC-01 (varenicline solution) Nasal Spray

OC-01

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to the Screening Visit

You may not qualify if:

• Have had any intraocular surgery (such as cataract surgery) or extraocular surgery in either eye within three months or refractive surgery (e.g., laser-assisted in-situ keratomileusis, laser epithelial keratomileusis, photorefractive keratectomy or corneal implant) within 12 months of the Screening Visit
• Have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, acute conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with DED are allowed.
• Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)
• Have a known hypersensitivity to any of the procedural agents or investigational product components
• Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject.

Sponsors & Collaborators

• Corxel Pharmaceuticals: lead
• Oyster Point Pharma, Inc.: collaborator

Study Sites (1)

Huashan Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Nasal Sprays

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• LU, Doctor

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

• ZHANG, Doctor

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

• DING

  Corxel Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 12, 2022
• Study Start: December 7, 2022
• Primary Completion: April 27, 2023
• Study Completion: April 27, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-04

Locations

CN (1)