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This is a Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of RC017 Ophthalmic Ointment Following Single and Multiple Doses in Healthy Adult Participants.RC017 is a small-molecule drug, being developed as a novel therapeutic treatment for patients with Dry Eye Disease (DED) . This study aims to evaluate the safety, tolerability and pharmacokinetics of RC017 after Single and Multiple Doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RC017 Ophthalmic Ointment | Experimental |
| |
| RC017 Ophthalmic Ointment placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RC017 Ophthalmic Ointment | Drug | Participants were randomly assigned to the 3 dose groups |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of Treatment-emergent adverse events (TEAEs) | Day1 to Day 21 | |
| The severity of Treatment-emergent adverse events (TEAEs) | Day 1-Day 21 | |
| The incidence of Serious adverse events (SAEs) | Day 1-Day 21 | |
| The severity of Serious adverse events (SAEs) | Day 1-Day 21 | |
| Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters | Day 1-Day 21 | |
| Number of participants with abnormal clinically significant clinical laboratory results | Day 1- Day 21 | |
| Number of patients with abnormal clinically significant results from physical examination | Day 1-Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | Day 1-Day 14 | |
| AUC from time zero to infinity (AUC0-∞) | Day 1-Day 14 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shang | Contact | +86-15366078819 | minghongshang@rejutec.com.cn |
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| RC017 Ophthalmic Ointment placebo | Drug | Match to RC017 Ophthalmic Ointment dose groups |
|
| Maximum observed concentration (Cmax) |
| Day 1-Day 14 |
| Time of maximum observed concentration (Tmax) | Day 1 - Day 14 |
| Terminal elimination half life(t1/2) | Day 1-Day 14 |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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