Evaluate the Tolerance, Safety and Pharmacokinetics of Germinal Peptide Eye Drops in Healthy Volunteers

NCT03662971 | Completed Phase 1

• 1 other identifier: ZK-SFT-201704
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I Clinical Trial to Evaluate the Tolerance, Safety and Pharmacokinetics of Germinal Peptide Eye Drops in Healthy Volunteers.

Conditions

Corneal Defect

Outcome Measures

Primary Outcomes (1)

• ocular symptoms

  Ocular signs: conjunctival congestion, corneal epithelial injury, conjunctival edema, anterior chamber glow.

  Within two days after administration

Secondary Outcomes (16)

• Area under curve （0-t）

  Within two days after administration

• Area under curve（0-∞）

  Within two days after administration

• Peak concentration

  Within two days after administration

• Peak time

  Within two days after administration

• Half life

  Within two days after administration

Study Arms (8)

0.0005% single-dose

EXPERIMENTAL

Two subjects will be treated with Germinal peptide eye drops 0.0005% single dose.

Drug: Germinal peptide eye drops

0.001% single-dose

EXPERIMENTAL

Ten subjects will be treated with Germinal peptide eye drops 0.001% single dose (eight treatment and two placebo).

Drug: Germinal peptide eye drops

0.002% single-dose

EXPERIMENTAL

Ten subjects will be treated with Germinal peptide eye drops 0.002% single dose (eight treatment and two placebo).

Drug: Germinal peptide eye drops

0.004% single-dose

EXPERIMENTAL

Ten subjects will be treated with Germinal peptide eye drops 0.004% single dose (eight treatment and two placebo).

Drug: Germinal peptide eye drops

0.008% single-dose

EXPERIMENTAL

Ten subjects will be treated with Germinal peptide eye drops 0.008% single dose (eight treatment and two placebo).

Drug: Germinal peptide eye drops

0.002% multiple-dose

EXPERIMENTAL

Ten subjects will be treated with Germinal peptide eye drops 0.002% multiple dose (eight treatment and two placebo).

Drug: Germinal peptide eye drops

0.004% multiple-dose

EXPERIMENTAL

Ten subjects will be treated with Germinal peptide eye drops 0.004% multiple dose (eight treatment and two placebo).

Drug: Germinal peptide eye drops

0.008% multiple-dose

EXPERIMENTAL

Ten subjects will be treated with Germinal peptide eye drops 0.008% multiple dose (eight treatment and two placebo).

Drug: Germinal peptide eye drops

Interventions

Germinal peptide eye drops DRUG

Germinal peptide eye drops of 0.0005%, 0.001%, 0.002%, 0.004% and 0.008%

Also known as: Germinal peptide

0.0005% single-dose; 0.001% single-dose; 0.002% multiple-dose; 0.002% single-dose; 0.004% multiple-dose; 0.004% single-dose; 0.008% multiple-dose; 0.008% single-dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers aged between 18 and 45, both male and female;
• The body mass index was between 19 and 26kg/m2 (including the critical value), the weight of male ≥50kg, and that of female ≥45kg；
• The BCVA of both eyes should be ≥ 1.0, and the intraocular pressure, slit lamp and fundus examination were all normal or abnormal values without clinical significance；
• Before the test, physical examination, vital signs, ECG, laboratory examination were in the normal range or no clinical significance；
• Subjects volunteered to participate in the study and signed ICF.

You may not qualify if:

• Patients with eye diseases, including a history of internal eye surgery or laser surgery;
• History of central nervous system, spirit system, cardiovascular system, kidney system, liver system, respiration system, metabolism and skeletal muscle system;
• Positive results of hepatitis B virus surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies , syphilis spiral antibody (TP-Ab) or r anti-human immunodeficiency virus (HIV) antibodies;
• A significant clinical history of allergic reactions, especially drug allergies, especially allergic to any ingredient in Germinal peptide eye drops;
• Smoking more than 5 cigarettes a day on average;
• Suspicion or actual alcohol dependence; intake of more than 2 units of alcohol per day on average in 3 months (1 unit =10 mL ethanol,, 1 unit =200mL of beer or 25 mL of spirits with 40% alcohol or 83 mL of wine with 12% alcohol) or alcohol test positive;
• History of drug abuse, or a positive urine test of ketamine, morphine, methamphetamine, dimethylamine and tetrahydrocannabinoid;
• Take any medicine within 2 weeks before screening;
• Participated in clinical trials within 3 months before screening;
• Donation or loss of more than 400 ml of blood within 3 months before screening
• Used ophthalmic drugs or eyelash growth fluid within 2 weeks before screening;
• Used contact lenses or cosmetic contact lenses within 2 weeks before screening;
• Pregnant or lactating women and planned pregnancies (including male subjects);
• The researcher considers that it is not suitable for the trial.

Sponsors & Collaborators

• Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.: lead

Study Sites (1)

Xiuli Zhao

Beijing, BJ10, China

Location

Study Officials

• Xiuli Zhao, PhD

  Beijing Tongren Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: September 10, 2018
• Study Start: October 29, 2018
• Primary Completion: December 4, 2018
• Study Completion: October 24, 2019
• Last Updated: February 5, 2020

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)