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This is a Randomized, Single-blind, Placebo-Controlled Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of Subcutaneously Administered RBD1119 in Healthy Participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RBD1119 SAD experimental group | Experimental | Subjects in SAD experimental groups will receive a single subcutaneous injection of RBD1119 on Day 1. |
|
| Placebo SAD group | Placebo Comparator | Subjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RBD1119 | Drug | Subcutaneously Administered RBD1119 in Healthy Subjects. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0 | Up to Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0 | After day 85 | |
| To characterize the pharmacokinetics (PK) as maximum plasma concentration (Cmax) of RBD1119 in healthy participants | Up to 48 hours post-dose |
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Main Inclusion Criteria:
Main Exclusion Criteria:
Any uncontrolled or serious disease that may interfere with participation in the clinical trial and/or put the participant at significant risk (according to Principal Investigator or delegate's judgment) if he/she participates in the clinical trial.
History or presence of cardiovascular disease (including peripheral artery and cerebrovascular disease).
Systolic blood pressure (SBP) is less than 90 or greater than 140 mmHg and/or diastolic blood pressure (DBP) is less than 50 or greater than 95 mmHg after 10 minutes of supine rest, unless determined by the Principal Investigator or delegate to be not clinically significant.
Diagnosis of diabetes mellitus, history of gestational diabetes that has not been fully resolved is not permitted.
History or presence of:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX Clinical Research | Adelaide | Australia |
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| Placebo |
| Drug |
Subcutaneously Administered Placebo in Healthy Subject. |
|
| To evaluate the pharmacodynamics (PD) effect of RBD1119 as percentage change from baseline in intrinsic coagulation pathway related antigen levels in healthy participants. | Up to Day 169. |
| To characterize the pharmacokinetics (PK) as Time to reach Cmax (Tmax) of RBD1119 in healthy participants | Up to 48 hours post-dose |
| To characterize the pharmacokinetics (PK) as area under the plasma concentration-time curve from the time zero to the last measurable concentration (AUC0-t) of RBD1119 in healthy participants | Up to 48 hours post-dose |
| To characterize the pharmacokinetics (PK) as area under the plasma concentration-time from time zero to infinity (AUC0-inf) of RBD1119 in healthy participants | Up to 48 hours post-dose |
| To characterize the pharmacokinetics (PK) as apparent terminal elimination half-life (t1/2) of RBD1119 in healthy participants | Up to 48 hours post-dose |
| To evaluate the pharmacodynamics (PD) effect of RBD1119 as percentage change from baseline in intrinsic coagulation pathway related activity levels in healthy participants. | Up to Day 169. |
| To evaluate the pharmacodynamics (PD) effect of RBD1119 as percentage change from baseline in APTT in healthy participants. | Up to Day 169. |