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This is a Phase 1A, first in human, randomized, double-blinded, placebo-controlled, dose escalation study of RC010 in healthy adult volunteers. RC010 is a small-molecule drug , being developed as a novel therapeutic treatment for patients with Idiopathic Pulmonary fibrosis (IPF). This study aims to evaluate the safety, tolerability and pharmacokinetics of RC010 after Single ascending doses .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RC010 Inhalation Powder | Experimental | RC010 Inhalation Powder:01.mg、0.3mg、0.75mg、1.5mg and 2mg,Single-dose administration |
|
| RC010 Inhalation Powder placebo | Experimental | RC010 Inhalation Powder placebo:0mg,Single-dose administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RC010 Inhalation Powder | Drug | Participants were randomly assigned to the 0.1, 0.3, 0.75, 1.5 and 2 mg dose groups |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of Treatment-emergent adverse events (TEAEs) | Day1-Day14 | |
| The severity of Treatment-emergent adverse events (TEAEs) | Day 1-Day 14 | |
| The incidence of Serious adverse events (SAEs) | Day 1-Day 14 | |
| The severity of Serious adverse events (SAEs) | Day 1- Day 14 | |
| Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters | Day 1-Day 14 | |
| Number of participants with abnormal clinically significant clinical laboratory results | Day 1- Day 14 | |
| Number of patients with abnormal clinically significant results from physical examination | Day 1-Day 14 |
| 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 | |
|---|---|---|---|---|
| Minghong Shang | Contact | +86-15366078819 | minghongshang@rejutec.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | China |
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| RC010 Inhalation Powder placebo | Drug | Match to RC010 Inhalation Powder 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 |