Corneal NeovascularizationPhase 1NCT04620109
Clinical Evaluation of Safety and Tolerability of KDR2-2 Eye Drops in Healthy Volunteers With Pharmacokinetic Assessment
A Phase 1 study testing KDR2-2 in people with Corneal Neovascularization, run by Guangzhou HuiBoRui Biological Pharmaceutical Technology Co. Ltd at 1 site in United States.
Trial summary
A Phase 1 randomized, double blinded, placebo-controlled, single dose escalation (SDE) and repeat dose escalation (RDE) study to evaluate safety and tolerability, and PK of KDR2-2 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Neovascularization
- What is being tested?
- KDR2-2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2020to 30 Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must meet all the following criteria to be enrolled in the trial:
- Able to understand and willing to sign the ICF
- Healthy male and female subjects, non-smokers, 18-55 years of age
- With no significant medical history, and in good health as determined by detailed medical history (neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease), full physical examination, vital signs, 12-lead electrocardiogram (ECG), urinalysis and laboratory tests at screening. For eligibility purposes, abnormal laboratory or vital signs results may be repeated once if abnormal result is observed at the initial reading. Moreover, abnormalities found in the ECG may need to be confirmed by repeated measurements.
- Subjects must have adequate organ function according to the following laboratory values at Screening and on Day-1. Repeat testing is allowed for verification, at the discretion of the Investigator:
- Bone marrow function (absolute neutrophil count ≥ 1500/mm3 and platelet count ≥ 100,000/mm3)
Show all 19Show fewer
- Adequate liver function [alanine aminotransferase (ALT) ≤ 1.5 × upper limit normal (ULN) and alkaline phosphatase ≤ 1.5 × ULN, total bilirubin ≤ 1.5 mg/dL]
- Adequate renal function creatinine clearance 60 mL/min based on Cockcroft - Gault equation, or serum creatinine level ≤ 1.5 times the ULN.
- Be a female of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal and have an FSH > 40 mIU/mL, or surgically sterile [defined as having a bilateral oophorectomy, hysterectomy or tubal ligation]) or agree to one of the following to prevent pregnancy and, if a woman of childbearing potential, have a negative serum pregnancy test at screening:
- If a sexually active woman of childbearing potential (sexually active with a non-sterile male partner) agrees to prevent pregnancy by using double methods of contraception as follow until at least 30 days after the administration of the investigational product:
- simultaneous use of intra-uterine contraceptive device, placed at least 4 weeks prior to study drug administration, and condom for the male partner;
- simultaneous use of hormonal contraceptives, starting at least 4 weeks prior to study drug administration and must agree to use the same hormonal contraceptive throughout the study, and condom for the male partner;
- simultaneous use of diaphragm with intravaginally applied spermicide and male condom for the male partner, starting at least 7 days prior to study drug administration.
- Male subjects who are not vasectomized for at least 6 months and who are sexually active with a non-sterile female partner must agree to use double methods of contraception below from the first dose of randomized study drug until 7 days after their dose and must not donate sperm during their study participation period:
- simultaneous use of a male condom and, for the female partner, hormonal contraceptives (used since at least 4 weeks) or intra-uterine contraceptive device (placed since at least 4 weeks);
- simultaneous use of a male condom and, for the female partner, a diaphragm with intravaginally applied spermicide.
- Body mass index (BMI) 19.0-32.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
- Blood pressure ≤ 139/89 mm Hg at screening and on Day -1. If abnormal findings deemed by the Investigator as not clinically significant, it may be repeated.
- Subjects are able to follow the study protocol and complete the trial.
Who cannot join
- Subjects who meet any of the following criteria cannot be enrolled:
- History of severe infection within 4 weeks prior to administration; signs and symptoms of any active infection regardless of severity within 2 weeks prior to administration.
- History of eye infection, or trauma or surgeries including LASIK.
- Subjects with a single eye.
- History of hypersensitivity to similar drugs to KDR2-2 or their excipients.
- Clinically significant abnormalities on ocular examination, including slit lamp, that would hinder the assessment of the eye or data collection at the discretion of the Investigator and/or ophthalmologist.
Show all 21Show fewer
- Any corrected visual acuity < 20/20, or intraocular pressure ≥ 20 mmHg.
- Subjects who wear contact lenses within 1 month prior to administration, or will wear contact lenses during the trial.
- Use of any prescription drugs excluding hormonal contraception, herbal supplements, or nonprescription drugs, including oral anti-histamines (for seasonal allergies) or ophthalmology drugs, within 1 month (30 days) or 5 half-lives (whichever is longer) prior to study drug administration, or dietary supplements within 1 week prior to study drug administration, unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study. Over-the-counter multivitamins will be permitted. If needed, paracetamol/acetaminophen may be used, but must be documented in the concomitant medications/significant non-drug therapies page of the source data. Exclusion applies to the use of Tropicamide 1% for the dilated retinal examination during baseline and final visit. Any questions of concomitant medications should be directed to the Sponsor.
- Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
- Donation of blood 12 week prior to dosing.
- Pregnant, or nursing females.
- A history of psychiatric and psychological condition that, in the judgment of the investigator, may interfere with the planned treatment and follow-up, affect subject compliance or place the subject at high risk from treatment-related complications
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTcF interval > 450 milliseconds [ms], Bazett Formula: QTc = QT/RR0.5）at Screening and on Day -1.
- Active hepatitis B or C. HBV carriers without active disease (HBV DNA titer < 1000 cps/mL or 200 IU/mL), or cured Hepatitis C (negative HCV RNA test) may be enrolled, in the judgement of the investigator.
- Human immunodeficiency virus (HIV) positive.
- Immunization with a live or attenuated vaccine is prohibited within 4 weeks prior to study drug administration. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed)
- History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]) or positive alcohol breath test at screening
- History of significant drug abuse within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening
- Positive urine drug screen, cotinine test, or alcohol breath test at screening
- Any reason which, in the opinion of the Investigator and Monitor, would prevent the subject from participating in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Parexel International
Glendale, California, 91206
Kyoko Tagawa
About this study
Official title: A Phase 1 Randomized, Double Blinded, Placebo-Controlled Single Dose and Repeat Dose Escalation Study to Evaluate Safety and Tolerability and Pharmacokinetic Characteristics of KDR2-2 in Adult Healthy Male and Female Volunteers
A Phase 1 randomized, double blinded, placebo-controlled, single dose escalation (SDE) and repeat dose escalation (RDE) study to evaluate safety and tolerability, and PK of KDR2-2 in healthy volunteers. The planned single dose levels are 0.03, 0.06, 0.12, and 0.24 mg/eye, and repeat dose levels are 0.06, 0.12, and 0.24 mg/eye, QID, × 6 days (one dose in the morning on Day 7). Subjects are randomized to KDR2-2 or placebo dosing (6:2 for SDE, or 8:2 for RDE) in each cohorts of relative dosing levels.
Read the detailed description
This is a Phase 1 randomized, double blinded, placebo-controlled, single dose and repeat dose escalation study to evaluate safety and tolerability, and PK of KDR2-2 in healthy volunteers.
The trial will include a screening period, a treatment period, and a follow-up period of 7 days for single dose escalation (SDE) or repeat dose escalation (RDE) after last administration. The screening period will be up to 28 days prior to investigational product administration. The screening process will initiate upon completion of the informed consent process. Once consent is provided by each participant, a thorough screening process will take place, including detailed medical history, physical examination and ophthalmology examination, vital signs, concomitant medications, safety labs, 12 lead electrocardiogram, serum pregnancy test, urinalysis, serology panel, assessment of inclusion and exclusion criteria. Upon completion of the screening, qualified subjects will be randomized to KDR2-2 or placebo (6:2 for SDE, or 8:2 for RDE). Each enrolled subject will receive one single or repeat assigned dose of KDR2-2 or placebo. The investigator and subjects will be blinded to treatment assignment. During the study, subjects will be evaluated for safety and tolerability, and PK of KDR2-2. In each cohort, a sentinel group of two subjects will be dosed first: one sentinel with KDR2-2, and the other with the placebo. The remaining subjects of the same cohort will be dosed at least 24 hours after sentinel dosing with approval from the principal investigator upon assessing the sentinel group.
KDR2-2 or placebo will be topically administered in the right eye as a single or repeat instillation on Day 1. Subjects will have end-of-study (EOS) follow-up visits on Day 8 (±1) for SDE or Day 15 (±1) for RDE.
The planned single dose levels are 0.03, 0.06, 0.12, and 0.24 mg/eye, and repeat dose levels are 0.06, 0.12, and 0.24 mg/eye, QID, × 6 days (one dose in the morning on Day 7). The Starting dose of KDR2-2 in repeat dose escalation stage will be at least 2 dose levels below the highest single dose level shown to be safe, for example, if 0.24 mg is proven to be safe during SDE, the starting dose during RDE will be 0.06 mg. Other higher dose level(s) might be optional based on emerging data from this study.
- Conditions
- Corneal Neovascularization
- Being tested
- KDR2-2, Placebo
- Keywords
- Corneal neovascularization
- Medical subject headings
- Corneal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KDR2-2Drug
Also called KDR2-2 suspension eyedrop, KDR2-2 ophthalmic suspension
KDR2-2 is a synthetic anti-angiogenic chemical compound with highly effective inhibition on vascular endothelial growth factor receptor-2 (VEGFR2), and an additional, moderate inhibitory effect on platelet-derived growth factor receptor β (PDGFRβ).
KDR2-2 suspension eye drop is in development for the treatment of corneal neovascularization.
PlaceboDrug
Placebo : the formulation and the product process of placebo are the same as the KDR2-2 eye drops, but without API .
| Study group | Role | What they receive |
|---|---|---|
| SDE Placebo | Placebo comparator | Subjects will receive placebo (drops without drug). Receives: Drug: Placebo |
| SDE 0.03 mg/eye | Active comparator | Actual dose is 0.03 mg/eye by 60μL KDR2-2 eyedrops of a concentration of 0.5 mg/mL for 1 time. Receives: Drug: KDR2-2 |
| SDE 0.06 mg/eye | Active comparator | Actual dose is 0.06 mg/eye by 60μL KDR2-2 eyedrops of a concentration of 1.0 mg/mL for 1 time. Receives: Drug: KDR2-2 |
| SDE 0.12 mg/eye | Active comparator | Actual dose is 0.12 mg/eye by 60μL KDR2-2 eyedrops of a concentration of 2.0 mg/mL for 1 time. Receives: Drug: KDR2-2 |
| SDE 0.24 mg/eye | Active comparator | Actual dose is 0.24 mg/eye by 60μL KDR2-2 eyedrops of a concentration of 4 mg/mL for 1 time. Receives: Drug: KDR2-2 |
| RDE 0.06 mg/eye | Active comparator | The actual dosage is 0.06 mg/eye given 4 times a day for a maximum daily dosage of 0.24mg (60μL KDR2-2 eyedrops concentration of 1.0 mg/mL), which will continues for 6 days plus 1 administration of 0.06 mg/eye in the morning of Day 7. That cohort only started after safety proof from SDE 0.24 mg/eye cohort. Receives: Drug: KDR2-2 |
| RDE 0.12 mg/eye | Active comparator | The actual dosage is 0.12 mg/eye given 4 times a day for a maximum daily dosage of 0.48mg (60μL KDR2-2 eyedrops concentration of 2.0 mg/mL), which will continues for 6 days plus 1 administration of 0.12 mg/eye in the morning of Day 7. That cohort might be optional based on emerging data from this study. Receives: Drug: KDR2-2 |
| RDE 0.24 mg/eye | Active comparator | The actual dosage is 0.24 mg/eye given 4 times a day for a maximum daily dosage of 0.96mg (60μL KDR2-2 eyedrops concentration of 4.0 mg/mL), which will continues for 6 days plus 1 administration of 0.24 mg/eye in the morning of Day 7. That cohort might be optional based on emerging data from this study. Receives: Drug: KDR2-2 |
| RDE Placebo | Placebo comparator | Subjects will receive placebo (drops without drug). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AE reporting for safety and tolerability (SDE)
AEs are documented and recorded per Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
Measured: 31 days
Incidence of SAE reporting for safety and tolerability (SDE)
Measured: through study completion, an average of 1 year
Body temperature for safety and tolerability (SDE)
Measured: 8 days for follow-up visit
Pulse rate for safety and tolerability (SDE)
Measured: 8 days for follow-up visit
Respiration rate for safety and tolerability (SDE)
Measured: 8 days for follow-up visit
Blood pressure for safety and tolerability (SDE)
Measured: 8 days for follow-up visit
Incidence of discomfort by clinical inquiring and observation for safety and tolerability (SDE)
Measured: 8 days for follow-up visit
Incidence of abnomal physical findings for safety and tolerability (SDE)
Via physical examination. Full physical examination including the cardiovascular, pulmonary, gastrointestinal, and nerve system and skin will be performed at screening and end of study visits, and partial physical examination can be done to assess any abnormalities or change from baseline, including focused skin and cardiopulmonary examination, and as clinically indicated.
Measured: 8 days for follow-up visit
Visual acuity for safety and tolerability (SDE)
Measured: 8 days for follow-up visit
Intraocular pressure for safety and tolerability (SDE)
Via tonopen or Goldmann tonometer.
Measured: 8 days for follow-up visit
Incidence of abnomal extraocular and anterior segament findings for safety and tolerability (SDE)
Via bare eye and a slit lamp microscopy. Examination includes eyelid, cornea, anterior chamber, lens and conjunctiva (palpebral and bulbar).
Fluorescein staining of cornea and conjunctival surfaces under a slit lamp microscopy.
Measured: 8 days for follow-up visit
White blood cell, red blood cell, platelet count, absolute neutrophils, monocytes , lymphocytes esoinophils and basophils (SDE)
Unit: X10E3/uL. In hematology for safety and tolerability
Measured: 8 days for follow-up visit
Percentage of netrophils, monocytes, lymphocytes, eosinophils, basophils, hematocrit and mean cellular HGB concentration in hematology (SDE)
Unit: %. In hematology for safety and tolerability
Measured: 8 days for follow-up visit
Mean cellulara HGB in hematology (SDE)
Unit: pg. In hematology for safety and tolerability
Measured: 8 days for follow-up visit
Mean cellular volume in hematology (SDE)
Unit: fL. In hematology for safety and tolerability
Measured: 8 days for follow-up visit
Hemoglobin in hematology (SDE)
Unit: g/dL. In hematology for safety and tolerability
Measured: 8 days for follow-up visit
Weight (SDE)
Unit: kg. In chemistry for GFP calculation
Measured: 8 days for follow-up visit
Akaline phosphatase, ALT, amylase, AST, creatine kinase, GGT and LDH in chemistry (SDE)
Unit: U/L. In chemistry for safety and tolerability
Measured: 8 days for follow-up visit
Serum chloride, potassium and sodium in chemistry (SDE)
Unit: mmol/L. In chemistry for safety and tolerability
Measured: 8 days for follow-up visit
Direct bilirubin, total bilirubin, urea nitrogen, calcium, cholesterol, creatinine, fasting glucose, triglycerides and uric acid in chemistry (SDE)
Unit: mg/dL. In chemistry for safety and tolerability
Measured: 8 days for follow-up visit
GFR estimate (Cockcroft-Gault) in chemistry (SDE)
Unit: mL/min. In chemistry for safety and tolerability
Measured: 8 days for follow-up visit
Albumin, globulin, total protein in chemistry (SDE)
Unit: g/dL. In chemistry for safety and tolerability
Measured: 8 days for follow-up visit
A/G ratio in chemistry (SDE)
Unit: NA. In chemistry for safety and tolerability
Measured: 8 days for follow-up visit
Partial thromboplastin time, prothrombin time and thrombin time in coagulation (SDE)
Unit: second. Unit: second. In coagulation for safety and tolerability
Measured: 8 days for follow-up visit
Fibrinogen in coagulation (SDE)
Unit: mg/dL. In coagulation for safety and tolerability
Measured: 8 days for follow-up visit
International normalized ratio in coagulation (SDE)
Unit: NA In coagulation for safety and tolerability
Measured: 8 days for follow-up visit
Incidence of abnormal urine analysis by blood, glucose, ketones, leukocyte, protein, nitrite, bilirubin and urobilinogen in urine analysis (SDE)
Unit: QUAL. In urine analysis for safety and tolerability
Measured: 8 days for follow-up visit
PH in urine analysis (SDE)
Unit: NA In urine analysis for safety and tolerability
Measured: 8 days for follow-up visit
Specific gravity in urine analysis (SDE)
Unit: NA In urine analysis for safety and tolerability
Measured: 8 days for follow-up visit
Heart rate for safety and tolerability (SDE)
By triplicate 12-lead electrocardiogram
Measured: 8 days for follow-up visit
QRS wave interval, QT interval, QTC interval, PQ interval, P wave interval and RR interval for safety and tolerability (SDE)
By triplicate 12-lead electrocardiogram
Measured: 8 days for follow-up visit
QRS angle value for safety and tolerability (SDE)
By triplicate 12-lead electrocardiogram
Measured: 8 days for follow-up visit
QTCF value for safety and tolerability (SDE)
By triplicate 12-lead electrocardiogram
Measured: 8 days for follow-up visit
Satisfaction assessed by Ocular Surface Disease Index (OSDI) questionnaires for safety and tolerability (SDE)
0-100 points. Higher score means more severe discomfort of ocular surface.
Measured: 8 days for follow-up visit
Satisfaction assessed by National Eye Institute 25-Item Visual Function (NEI-VFQ25) questionnaires for safety and tolerability (SDE)
0-100 points. Higher score means better vision function.
Measured: 8 days for follow-up visit
Incidence of AE reporting for safety and tolerability (RDE)
AEs are documented and recorded per Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
Measured: 48 days
Incidence of SAE reporting for safety and tolerability (RDE)
Measured: Through study completion, an average of 1 year
Body temperature for safety and tolerability (RDE)
Measured: 15 days for follow-up visit
Pulse rate for safety and tolerability (RDE)
Measured: 15 days for follow-up visit
Respiration rate for safety and tolerability (RDE)
Measured: 15 days for follow-up visit
Blood pressure for safety and tolerability (RDE)
Measured: 15 days for follow-up visit
Incidence of discomfort by clinical inquiring and observation for safety and tolerability (RDE)
Measured: 15 days for follow-up visit
Incidence of abnomal physical findings for safety and tolerability (RDE)
Via physical examination. Full physical examination including the cardiovascular, pulmonary, gastrointestinal, and nerve system and skin will be performed at screening and end of study visits, and partial physical examination can be done to assess any abnormalities or change from baseline, including focused skin and cardiopulmonary examination, and as clinically indicated.
Measured: 15 days for follow-up visit
Visual acuity for safety and tolerability (RDE)
Measured: 15 days for follow-up visit
Intraocular pressure for safety and tolerability (RDE)
Via tonopen or Goldmann tonometer.
Measured: 15 days for follow-up visit
Incidence of abnomal extraocular and anterior segament findings for safety and tolerability (RDE)
Via bare eye and a slit lamp microscopy. Examination includes eyelid, cornea, anterior chamber, lens and conjunctiva (palpebral and bulbar).
Fluorescein staining of cornea and conjunctival surfaces under a slit lamp microscopy.
Measured: 15 days for follow-up visit
Incidence of abnormal findings from dilated fundus exam (RDE)
Dilated fundus exam for once at D15.
Measured: 15 days for follow-up visit
White blood cell, red blood cell, platelet count, absolute neutrophils, monocytes , lymphocytes esoinophils and basophils in hematology for safety and tolerability (RDE)
Unit: X10E3/uL. In hematology for safety and tolerability
Measured: 15 days for follow-up visit
Percentage of netrophils, monocytes, lymphocytes, eosinophils, basophils, hematocrit and mean cellular HGB CON/MCHC in hematology (RDE)
Unit: %. In hematology for safety and tolerability
Measured: 15 days for follow-up visit
Mean cellulara HGB in hematology (RDE)
Unit: pg. In hematology for safety and tolerability
Measured: 15 days for follow-up visit
Mean cellular volume in hematology (RDE)
Unit: fL. In hematology for safety and tolerability
Measured: 15 days for follow-up visit
Hemoglobin in hematology (RDE)
Unit: g/dL . In hematology for safety and tolerability
Measured: 15 days for follow-up visit
Weight (RDE)
Unit: kg. In chemistry for GFP calculation
Measured: 15 days for follow-up visit
Akaline phosphatase, ALT, amylase, AST, creatine kinase, GGT and LDH in chemistry (RDE)
Unit: U/L. In chemistry for safety and tolerability
Measured: 15 days for follow-up visit
Serum chloride, potassium and sodium in chemistry (RDE)
Unit: mmol/L. In chemistry for safety and tolerability
Measured: 15 days for follow-up visit
Direct bilirubin, total bilirubin, urea nitrogen, calcium, cholesterol, creatinine, fasting glucose, triglycerides and uric acid in chemistry (RDE)
Unit: mg/dL. In chemistry for safety and tolerability
Measured: 15 days for follow-up visit
GFR estimate (Cockcroft-Gault) in chemistry (RDE)
Unit: mL/min. In chemistry for safety and tolerability
Measured: 15 days for follow-up visit
Albumin, globulin, total protein in chemistry (RDE)
Unit: g/dL. In chemistry for safety and tolerability
Measured: 15 days for follow-up visit
A/G ratio in chemistry (RDE)
Unit: NA. In chemistry for safety and tolerability
Measured: 15 days for follow-up visit
Partial thromboplastin time, prothrombin time and thrombin time in chemistry (RDE)
Unit: second. In coagulation for safety and tolerability
Measured: 15 days for follow-up visit
Fibrinogen in coagulation (RDE)
Unit: mg/dL. In coagulation for safety and tolerability
Measured: 15 days for follow-up visit
International normalized ratio in coagulation (RDE)
Unit: NA. In coagulation for safety and tolerability
Measured: 15 days for follow-up visit
Incidence of abnormal urine analysis by blood, glucose, ketones, leukocyte, protein, nitrite, bilirubin and urobilinogen in urine analysis (RDE)
Unit: QUAL. In urine analysis for safety and tolerability
Measured: 15 days for follow-up visit
PH in urine analysis (RDE)
Unit: NA. In urine analysis for safety and tolerability
Measured: 15 days for follow-up visit
Specific gravity in urine analysis (RDE)
Unit: NA. In urine analysis for safety and tolerability
Measured: 15 days for follow-up visit
Heart rate for safety and tolerability (RDE)
By triplicate 12-lead electrocardiogram
Measured: 15 days for follow-up visit
QRS wave interval, QT interval, QTC interval, PQ interval, P wave interval and RR interval for safety and tolerability (RDE)
By triplicate 12-lead electrocardiogram
Measured: 15 days for follow-up visit
QRS angle value for safety and tolerability (RDE)
By triplicate 12-lead electrocardiogram
Measured: 15 days for follow-up visit
QTCF value for safety and tolerability (RDE)
By triplicate 12-lead electrocardiogram
Measured: 15 days for follow-up visit
Satisfaction assessed by Ocular Surface Disease Index (OSDI) questionnaires for safety and tolerability (RDE)
0-100 points. Higher score means more severe discomfort of ocular surface.
Measured: 15 days for follow-up visit
Satisfaction assessed by National Eye Institute 25-Item Visual Function (NEI-VFQ25) questionnaires for safety and tolerability (RDE)
0-100 points. Higher score means better vision function.
Measured: 15 days for follow-up visit
Secondary outcomes (12)
AUC0-∞ in each SDE cohort
Measured: 2 days
AUC0-t in each SDE cohort
Measured: 2 days
Cmax in each SDE cohort
Measured: 2 days
t1/2 in each SDE cohort
Measured: 2 days
CL in each SDE cohort
Measured: 2 days
Vd in each SDE cohort
Measured: 2 days
AUC0-∞ in each RDE cohort
Measured: 8 days
AUC0-t in each RDE cohort
Measured: 8 days
Cmax in each RDE cohort
Measured: 8 days
t1/2 in each RDE cohort
Measured: 8 days
CL in each RDE cohort
Measured: 8 days
Vd in each RDE cohort
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start26 Aug 2020
- Primary completion31 Mar 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal NeovascularizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou HuiBoRui Biological Pharmaceutical Technology Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620109
- Sponsor's protocol ID
- HBR2019-101
- Status last verified
- Nov 2020
- First submitted
- 19 Oct 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double Blinded, Placebo-Controlled Single Dose and Repeat Dose Escalation Study to Evaluate Safety and Tolerability and Pharmacokinetic Characteristics of KDR2-2 in Adult Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT04620109
- Acronym / sponsor ID
- HBR2019-101
- Conditions
- Corneal Neovascularization
- Keywords
- Corneal neovascularization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Guangzhou HuiBoRui Biological Pharmaceutical Technology Co. LtdIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1 randomized, double blinded, placebo-controlled, single dose escalation (SDE) and repeat dose escalation (RDE) study to evaluate safety and tolerability, and PK of KDR2-2 in healthy volunteers. The planned single dose levels are 0.03, 0.06, 0.12, and 0.24 mg/eye, and repeat dose levels are 0.06, 0.12, and 0.24 mg/eye, QID, × 6 days (one dose in the morning on Day 7). Subjects are randomized to KDR2-2 or placebo dosing (6:2 for SDE, or 8:2 for RDE) in each cohorts of relative dosing levels.
Detailed description
This is a Phase 1 randomized, double blinded, placebo-controlled, single dose and repeat dose escalation study to evaluate safety and tolerability, and PK of KDR2-2 in healthy volunteers.
The trial will include a screening period, a treatment period, and a follow-up period of 7 days for single dose escalation (SDE) or repeat dose escalation (RDE) after last administration. The screening period will be up to 28 days prior to investigational product administration. The screening process will initiate upon completion of the informed consent process. Once consent is provided by each participant, a thorough screening process will take place, including detailed medical history, physical examination and ophthalmology examination, vital signs, concomitant medications, safety labs, 12 lead electrocardiogram, serum pregnancy test, urinalysis, serology panel, assessment of inclusion and exclusion criteria. Upon completion of the screening, qualified subjects will be randomized to KDR2-2 or placebo (6:2 for SDE, or 8:2 for RDE). Each enrolled subject will receive one single or repeat assigned dose of KDR2-2 or placebo. The investigator and subjects will be blinded to treatment assignment. During the study, subjects will be evaluated for safety and tolerability, and PK of KDR2-2. In each cohort, a sentinel group of two subjects will be dosed first: one sentinel with KDR2-2, and the other with the placebo. The remaining subjects of the same cohort will be dosed at least 24 hours after sentinel dosing with approval from the principal investigator upon assessing the sentinel group.
KDR2-2 or placebo will be topically administered in the right eye as a single or repeat instillation on Day 1. Subjects will have end-of-study (EOS) follow-up visits on Day 8 (±1) for SDE or Day 15 (±1) for RDE.
The planned single dose levels are 0.03, 0.06, 0.12, and 0.24 mg/eye, and repeat dose levels are 0.06, 0.12, and 0.24 mg/eye, QID, × 6 days (one dose in the morning on Day 7). The Starting dose of KDR2-2 in repeat dose escalation stage will be at least 2 dose levels below the highest single dose level shown to be safe, for example, if 0.24 mg is proven to be safe during SDE, the starting dose during RDE will be 0.06 mg. Other higher dose level(s) might be optional based on emerging data from this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| SDE Placebo | Placebo comparator | Drug: PlaceboSubjects will receive placebo (drops without drug). |
| SDE 0.03 mg/eye | Active comparator | Drug: KDR2-2Actual dose is 0.03 mg/eye by 60μL KDR2-2 eyedrops of a concentration of 0.5 mg/mL for 1 time. |
| SDE 0.06 mg/eye | Active comparator | Drug: KDR2-2Actual dose is 0.06 mg/eye by 60μL KDR2-2 eyedrops of a concentration of 1.0 mg/mL for 1 time. |
| SDE 0.12 mg/eye | Active comparator | Drug: KDR2-2Actual dose is 0.12 mg/eye by 60μL KDR2-2 eyedrops of a concentration of 2.0 mg/mL for 1 time. |
| SDE 0.24 mg/eye | Active comparator | Drug: KDR2-2Actual dose is 0.24 mg/eye by 60μL KDR2-2 eyedrops of a concentration of 4 mg/mL for 1 time. |
| RDE 0.06 mg/eye | Active comparator | Drug: KDR2-2The actual dosage is 0.06 mg/eye given 4 times a day for a maximum daily dosage of 0.24mg (60μL KDR2-2 eyedrops concentration of 1.0 mg/mL), which will continues for 6 days plus 1 administration of 0.06 mg/eye in the morning of Day 7. That cohort only started after safety proof from SDE 0.24 mg/eye cohort. |
| RDE 0.12 mg/eye | Active comparator | Drug: KDR2-2The actual dosage is 0.12 mg/eye given 4 times a day for a maximum daily dosage of 0.48mg (60μL KDR2-2 eyedrops concentration of 2.0 mg/mL), which will continues for 6 days plus 1 administration of 0.12 mg/eye in the morning of Day 7. That cohort might be optional based on emerging data from this study. |
| RDE 0.24 mg/eye | Active comparator | Drug: KDR2-2The actual dosage is 0.24 mg/eye given 4 times a day for a maximum daily dosage of 0.96mg (60μL KDR2-2 eyedrops concentration of 4.0 mg/mL), which will continues for 6 days plus 1 administration of 0.24 mg/eye in the morning of Day 7. That cohort might be optional based on emerging data from this study. |
| RDE Placebo | Placebo comparator | Drug: PlaceboSubjects will receive placebo (drops without drug). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Able to understand and willing to sign the ICF
- Healthy male and female subjects, non-smokers, 18-55 years of age
- With no significant medical history, and in good health as determined by detailed medical history (neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease), full physical examination, vital signs, 12-lead electrocardiogram (ECG), urinalysis and laboratory tests at screening. For eligibility purposes, abnormal laboratory or vital signs results may be repeated once if abnormal result is observed at the initial reading. Moreover, abnormalities found in the ECG may need to be confirmed by repeated measurements.
- Subjects must have adequate organ function according to the following laboratory values at Screening and on Day-1. Repeat testing is allowed for verification, at the discretion of the Investigator:
- Be a female of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal and have an FSH > 40 mIU/mL, or surgically sterile [defined as having a bilateral oophorectomy, hysterectomy or tubal ligation]) or agree to one of the following to prevent pregnancy and, if a woman of childbearing potential, have a negative serum pregnancy test at screening:
Key exclusion criteria (21 listed)
- History of severe infection within 4 weeks prior to administration; signs and symptoms of any active infection regardless of severity within 2 weeks prior to administration.
- History of eye infection, or trauma or surgeries including LASIK.
- Subjects with a single eye.
- History of hypersensitivity to similar drugs to KDR2-2 or their excipients.
- Clinically significant abnormalities on ocular examination, including slit lamp, that would hinder the assessment of the eye or data collection at the discretion of the Investigator and/or ophthalmologist.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KDR2-2Also: KDR2-2 suspension eyedrop, KDR2-2 ophthalmic suspensionKDR2-2 is a synthetic anti-angiogenic chemical compound with highly effective inhibition on vascular endothelial growth factor receptor-2 (VEGFR2), and an additional, moderate inhibitory effect on platelet-derived growth factor receptor β (PDGFRβ). KDR2-2 suspension eye drop is in development for the treatment of corneal neovascularization. | Drug | RDE 0.06 mg/eye, RDE 0.12 mg/eye, RDE 0.24 mg/eye, SDE 0.03 mg/eye, SDE 0.06 mg/eye, SDE 0.12 mg/eye, SDE 0.24 mg/eye |
| PlaceboPlacebo : the formulation and the product process of placebo are the same as the KDR2-2 eye drops, but without API . | Drug | RDE Placebo, SDE Placebo |
Primary outcome
Incidence of AE reporting for safety and tolerability (SDE)
Time frame: 31 days
AEs are documented and recorded per Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
Incidence of SAE reporting for safety and tolerability (SDE)
Time frame: through study completion, an average of 1 year
Body temperature for safety and tolerability (SDE)
Time frame: 8 days for follow-up visit
Pulse rate for safety and tolerability (SDE)
Time frame: 8 days for follow-up visit
Respiration rate for safety and tolerability (SDE)
Time frame: 8 days for follow-up visit
Blood pressure for safety and tolerability (SDE)
Time frame: 8 days for follow-up visit
Incidence of discomfort by clinical inquiring and observation for safety and tolerability (SDE)
Time frame: 8 days for follow-up visit
Incidence of abnomal physical findings for safety and tolerability (SDE)
Time frame: 8 days for follow-up visit
Via physical examination. Full physical examination including the cardiovascular, pulmonary, gastrointestinal, and nerve system and skin will be performed at screening and end of study visits, and partial physical examination can be done to assess any abnormalities or change from baseline, including focused skin and cardiopulmonary examination, and as clinically indicated.
Visual acuity for safety and tolerability (SDE)
Time frame: 8 days for follow-up visit
Intraocular pressure for safety and tolerability (SDE)
Time frame: 8 days for follow-up visit
Via tonopen or Goldmann tonometer.
Incidence of abnomal extraocular and anterior segament findings for safety and tolerability (SDE)
Time frame: 8 days for follow-up visit
Via bare eye and a slit lamp microscopy. Examination includes eyelid, cornea, anterior chamber, lens and conjunctiva (palpebral and bulbar). Fluorescein staining of cornea and conjunctival surfaces under a slit lamp microscopy.
White blood cell, red blood cell, platelet count, absolute neutrophils, monocytes , lymphocytes esoinophils and basophils (SDE)
Time frame: 8 days for follow-up visit
Unit: X10E3/uL. In hematology for safety and tolerability
Percentage of netrophils, monocytes, lymphocytes, eosinophils, basophils, hematocrit and mean cellular HGB concentration in hematology (SDE)
Time frame: 8 days for follow-up visit
Unit: %. In hematology for safety and tolerability
Mean cellulara HGB in hematology (SDE)
Time frame: 8 days for follow-up visit
Unit: pg. In hematology for safety and tolerability
Mean cellular volume in hematology (SDE)
Time frame: 8 days for follow-up visit
Unit: fL. In hematology for safety and tolerability
Hemoglobin in hematology (SDE)
Time frame: 8 days for follow-up visit
Unit: g/dL. In hematology for safety and tolerability
Weight (SDE)
Time frame: 8 days for follow-up visit
Unit: kg. In chemistry for GFP calculation
Akaline phosphatase, ALT, amylase, AST, creatine kinase, GGT and LDH in chemistry (SDE)
Time frame: 8 days for follow-up visit
Unit: U/L. In chemistry for safety and tolerability
Serum chloride, potassium and sodium in chemistry (SDE)
Time frame: 8 days for follow-up visit
Unit: mmol/L. In chemistry for safety and tolerability
Direct bilirubin, total bilirubin, urea nitrogen, calcium, cholesterol, creatinine, fasting glucose, triglycerides and uric acid in chemistry (SDE)
Time frame: 8 days for follow-up visit
Unit: mg/dL. In chemistry for safety and tolerability
GFR estimate (Cockcroft-Gault) in chemistry (SDE)
Time frame: 8 days for follow-up visit
Unit: mL/min. In chemistry for safety and tolerability
Albumin, globulin, total protein in chemistry (SDE)
Time frame: 8 days for follow-up visit
Unit: g/dL. In chemistry for safety and tolerability
A/G ratio in chemistry (SDE)
Time frame: 8 days for follow-up visit
Unit: NA. In chemistry for safety and tolerability
Partial thromboplastin time, prothrombin time and thrombin time in coagulation (SDE)
Time frame: 8 days for follow-up visit
Unit: second. Unit: second. In coagulation for safety and tolerability
Fibrinogen in coagulation (SDE)
Time frame: 8 days for follow-up visit
Unit: mg/dL. In coagulation for safety and tolerability
International normalized ratio in coagulation (SDE)
Time frame: 8 days for follow-up visit
Unit: NA In coagulation for safety and tolerability
Incidence of abnormal urine analysis by blood, glucose, ketones, leukocyte, protein, nitrite, bilirubin and urobilinogen in urine analysis (SDE)
Time frame: 8 days for follow-up visit
Unit: QUAL. In urine analysis for safety and tolerability
PH in urine analysis (SDE)
Time frame: 8 days for follow-up visit
Unit: NA In urine analysis for safety and tolerability
Specific gravity in urine analysis (SDE)
Time frame: 8 days for follow-up visit
Unit: NA In urine analysis for safety and tolerability
Heart rate for safety and tolerability (SDE)
Time frame: 8 days for follow-up visit
By triplicate 12-lead electrocardiogram
QRS wave interval, QT interval, QTC interval, PQ interval, P wave interval and RR interval for safety and tolerability (SDE)
Time frame: 8 days for follow-up visit
By triplicate 12-lead electrocardiogram
QRS angle value for safety and tolerability (SDE)
Time frame: 8 days for follow-up visit
By triplicate 12-lead electrocardiogram
QTCF value for safety and tolerability (SDE)
Time frame: 8 days for follow-up visit
By triplicate 12-lead electrocardiogram
Satisfaction assessed by Ocular Surface Disease Index (OSDI) questionnaires for safety and tolerability (SDE)
Time frame: 8 days for follow-up visit
0-100 points. Higher score means more severe discomfort of ocular surface.
Satisfaction assessed by National Eye Institute 25-Item Visual Function (NEI-VFQ25) questionnaires for safety and tolerability (SDE)
Time frame: 8 days for follow-up visit
0-100 points. Higher score means better vision function.
Incidence of AE reporting for safety and tolerability (RDE)
Time frame: 48 days
AEs are documented and recorded per Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
Incidence of SAE reporting for safety and tolerability (RDE)
Time frame: Through study completion, an average of 1 year
Body temperature for safety and tolerability (RDE)
Time frame: 15 days for follow-up visit
Pulse rate for safety and tolerability (RDE)
Time frame: 15 days for follow-up visit
Respiration rate for safety and tolerability (RDE)
Time frame: 15 days for follow-up visit
Blood pressure for safety and tolerability (RDE)
Time frame: 15 days for follow-up visit
Incidence of discomfort by clinical inquiring and observation for safety and tolerability (RDE)
Time frame: 15 days for follow-up visit
Incidence of abnomal physical findings for safety and tolerability (RDE)
Time frame: 15 days for follow-up visit
Via physical examination. Full physical examination including the cardiovascular, pulmonary, gastrointestinal, and nerve system and skin will be performed at screening and end of study visits, and partial physical examination can be done to assess any abnormalities or change from baseline, including focused skin and cardiopulmonary examination, and as clinically indicated.
Visual acuity for safety and tolerability (RDE)
Time frame: 15 days for follow-up visit
Intraocular pressure for safety and tolerability (RDE)
Time frame: 15 days for follow-up visit
Via tonopen or Goldmann tonometer.
Incidence of abnomal extraocular and anterior segament findings for safety and tolerability (RDE)
Time frame: 15 days for follow-up visit
Via bare eye and a slit lamp microscopy. Examination includes eyelid, cornea, anterior chamber, lens and conjunctiva (palpebral and bulbar). Fluorescein staining of cornea and conjunctival surfaces under a slit lamp microscopy.
Incidence of abnormal findings from dilated fundus exam (RDE)
Time frame: 15 days for follow-up visit
Dilated fundus exam for once at D15.
White blood cell, red blood cell, platelet count, absolute neutrophils, monocytes , lymphocytes esoinophils and basophils in hematology for safety and tolerability (RDE)
Time frame: 15 days for follow-up visit
Unit: X10E3/uL. In hematology for safety and tolerability
Percentage of netrophils, monocytes, lymphocytes, eosinophils, basophils, hematocrit and mean cellular HGB CON/MCHC in hematology (RDE)
Time frame: 15 days for follow-up visit
Unit: %. In hematology for safety and tolerability
Mean cellulara HGB in hematology (RDE)
Time frame: 15 days for follow-up visit
Unit: pg. In hematology for safety and tolerability
Mean cellular volume in hematology (RDE)
Time frame: 15 days for follow-up visit
Unit: fL. In hematology for safety and tolerability
Hemoglobin in hematology (RDE)
Time frame: 15 days for follow-up visit
Unit: g/dL . In hematology for safety and tolerability
Weight (RDE)
Time frame: 15 days for follow-up visit
Unit: kg. In chemistry for GFP calculation
Akaline phosphatase, ALT, amylase, AST, creatine kinase, GGT and LDH in chemistry (RDE)
Time frame: 15 days for follow-up visit
Unit: U/L. In chemistry for safety and tolerability
Serum chloride, potassium and sodium in chemistry (RDE)
Time frame: 15 days for follow-up visit
Unit: mmol/L. In chemistry for safety and tolerability
Direct bilirubin, total bilirubin, urea nitrogen, calcium, cholesterol, creatinine, fasting glucose, triglycerides and uric acid in chemistry (RDE)
Time frame: 15 days for follow-up visit
Unit: mg/dL. In chemistry for safety and tolerability
GFR estimate (Cockcroft-Gault) in chemistry (RDE)
Time frame: 15 days for follow-up visit
Unit: mL/min. In chemistry for safety and tolerability
Albumin, globulin, total protein in chemistry (RDE)
Time frame: 15 days for follow-up visit
Unit: g/dL. In chemistry for safety and tolerability
A/G ratio in chemistry (RDE)
Time frame: 15 days for follow-up visit
Unit: NA. In chemistry for safety and tolerability
Partial thromboplastin time, prothrombin time and thrombin time in chemistry (RDE)
Time frame: 15 days for follow-up visit
Unit: second. In coagulation for safety and tolerability
Fibrinogen in coagulation (RDE)
Time frame: 15 days for follow-up visit
Unit: mg/dL. In coagulation for safety and tolerability
International normalized ratio in coagulation (RDE)
Time frame: 15 days for follow-up visit
Unit: NA. In coagulation for safety and tolerability
Incidence of abnormal urine analysis by blood, glucose, ketones, leukocyte, protein, nitrite, bilirubin and urobilinogen in urine analysis (RDE)
Time frame: 15 days for follow-up visit
Unit: QUAL. In urine analysis for safety and tolerability
PH in urine analysis (RDE)
Time frame: 15 days for follow-up visit
Unit: NA. In urine analysis for safety and tolerability
Specific gravity in urine analysis (RDE)
Time frame: 15 days for follow-up visit
Unit: NA. In urine analysis for safety and tolerability
Heart rate for safety and tolerability (RDE)
Time frame: 15 days for follow-up visit
By triplicate 12-lead electrocardiogram
QRS wave interval, QT interval, QTC interval, PQ interval, P wave interval and RR interval for safety and tolerability (RDE)
Time frame: 15 days for follow-up visit
By triplicate 12-lead electrocardiogram
QRS angle value for safety and tolerability (RDE)
Time frame: 15 days for follow-up visit
By triplicate 12-lead electrocardiogram
QTCF value for safety and tolerability (RDE)
Time frame: 15 days for follow-up visit
By triplicate 12-lead electrocardiogram
Satisfaction assessed by Ocular Surface Disease Index (OSDI) questionnaires for safety and tolerability (RDE)
Time frame: 15 days for follow-up visit
0-100 points. Higher score means more severe discomfort of ocular surface.
Satisfaction assessed by National Eye Institute 25-Item Visual Function (NEI-VFQ25) questionnaires for safety and tolerability (RDE)
Time frame: 15 days for follow-up visit
0-100 points. Higher score means better vision function.
12 secondary outcomes
AUC0-∞ in each SDE cohort
Time frame: 2 days
AUC0-t in each SDE cohort
Time frame: 2 days
Cmax in each SDE cohort
Time frame: 2 days
t1/2 in each SDE cohort
Time frame: 2 days
CL in each SDE cohort
Time frame: 2 days
Vd in each SDE cohort
Time frame: 2 days
AUC0-∞ in each RDE cohort
Time frame: 8 days
AUC0-t in each RDE cohort
Time frame: 8 days
Cmax in each RDE cohort
Time frame: 8 days
t1/2 in each RDE cohort
Time frame: 8 days
CL in each RDE cohort
Time frame: 8 days
Vd in each RDE cohort
Time frame: 8 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
Related trials for Corneal Neovascularization
RecruitingPhase 2/3
Corneal Crosslinking for Treatment of Corneal Neovascularization
Corneal Neovascularization
Recruiting
Fine-needle Diathermy Combined With Subconjunctival Bevacizumab for Corneal Neovascularization
Corneal Neovascularisation
RecruitingPhase 1/2
Clinical Study of Intrastromal Anti-VEGF Injection for Corneal Neovascularization.
Herpes Simplex Keratitis, Corneal Neovascularization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KDR2-2 in people with Corneal Neovascularization, run by Guangzhou HuiBoRui Biological Pharmaceutical Technology Co. Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyoko Tagawa (888-228-7425, study.losangeles@parexel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AE reporting for safety and tolerability (SDE) (time frame: 31 days). The study lists 71 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.