UnknownPhase 1

Clinical Evaluation of Safety and Tolerability of KDR2-2 Eye Drops in Healthy Volunteers With Pharmacokinetic Assessment

United States62 participantsStarted 2020-08-26

Plain-language 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. 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.

Who can participate

Age range18 Years – 55 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. 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.

What they're measuring

Incidence of AE reporting for safety and tolerability (SDE)

Timeframe: 31 days

Incidence of SAE reporting for safety and tolerability (SDE)

Timeframe: through study completion, an average of 1 year

Body temperature for safety and tolerability (SDE)

Timeframe: 8 days for follow-up visit

Pulse rate for safety and tolerability (SDE)

Timeframe: 8 days for follow-up visit

Respiration rate for safety and tolerability (SDE)

Timeframe: 8 days for follow-up visit

Blood pressure for safety and tolerability (SDE)

Timeframe: 8 days for follow-up visit

Incidence of discomfort by clinical inquiring and observation for safety and tolerability (SDE)

Timeframe: 8 days for follow-up visit

Incidence of abnomal physical findings for safety and tolerability (SDE)

Timeframe: 8 days for follow-up visit

Trial details

NCT IDNCT04620109

SponsorGuangzhou HuiBoRui Biological Pharmaceutical Technology Co. Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-03-31

Contact for this trial

Kyoko Tagawa

888-228-7425 study.losangeles@parexel.com

View on ClinicalTrials.gov More Corneal Neovascularization trials

Plain-language summary

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. 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.

What they're measuring

Incidence of AE reporting for safety and tolerability (SDE)

Timeframe: 31 days

Incidence of SAE reporting for safety and tolerability (SDE)

Timeframe: through study completion, an average of 1 year

Body temperature for safety and tolerability (SDE)

Timeframe: 8 days for follow-up visit

Pulse rate for safety and tolerability (SDE)

Timeframe: 8 days for follow-up visit

Respiration rate for safety and tolerability (SDE)

Timeframe: 8 days for follow-up visit

Blood pressure for safety and tolerability (SDE)

Timeframe: 8 days for follow-up visit

Incidence of discomfort by clinical inquiring and observation for safety and tolerability (SDE)

Timeframe: 8 days for follow-up visit

Incidence of abnomal physical findings for safety and tolerability (SDE)

Timeframe: 8 days for follow-up visit

Clinical Evaluation of Safety and Tolerability of KDR2-2 Eye Drops in Healthy Volunteers With Pharmacokinetic Assessment

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

Clinical Evaluation of Safety and Tolerability of KDR2-2 Eye Drops in Healthy Volunteers With Pharmacokinetic Assessment

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

Exclusion criteria