Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DRUGRBD1119
Subcutaneously Administered RBD1119 in Healthy Subjects.
DRUGPlacebo
Subcutaneously Administered Placebo in Healthy Subject.
Sponsors
Suzhou Ribo Life Science Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Main Inclusion Criteria: * Male or female healthy participants (non-childbearing potential only), aged 18 to 65 years at screening, inclusive. * Body mass index (BMI) between 18 and 32 kg/m2, inclusive * APTT, Prothrombin time (PT), INR, thrombin time (TT) within normal reference range (as per the local laboratory). * Haematology results within normal range, unless deemed not clinically significant by the Principal Investigator or delegate. Platelet count however must be within normal range per the local laboratory reference ranges. * Healthy as determined by no clinically significant findings by the Principal Investigator or delegate in medical history, vital signs, physical examination, clinical laboratory assessments, and 12-lead electrocardiogram (ECG). 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: * Bleeding disorder(s) and/or at risk of bleeding, including relevant familial history, such as Hemophilia A, Hemophilia B, Wiskott-Aldrich syndrome, von Willebrand disease (vWD); * Clinically significant anemia, in the opinion of the Principal Investigator or delegate; * Thromboembolic diseases; * Bleeding in the gastrointestinal tract or central nervous system; * Anticipated need for oral surgery or tooth extractions during the trial period; * Bleeding in the genitourinary tract; * Gum disease or active gum bleeding; * Planned surgery during the trial period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0 | Up to Day 85 |
Secondary
| Measure | 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 |
| 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. |
Countries
Australia
Outcome results
None listed