A Single and Multiple Ascending Doses Phase I Study to Evaluate the Safety and Pharmacokinetics of RBD4059 in Healthy Subjects
Healthy Volunteers
About this trial
This is an interventional treatment trial for Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and female (non-childbearing potential only), aged 18 to 65 years, inclusive. Body mass index (BMI) between 18 and 32 kg/m2, inclusive. APTT, Prothrombin time(PT), INR, thrombin time (TT),FXI activity must be within the normal reference range (as per the local laboratory reference range) at screening . Adequate complete blood counts (CBCs) and platelet are within the normal reference range (If CBCs are outside the reference range, unless not clinically significant determined by the Investigator ). Healthy as determined by pre-study medical history, vital signs, physical examination, clinical laboratory assessments, and 12-lead electrocardiogram (ECG). Subjects who are willing to cooperate with the study staff, comply with the study requirements, complete the study according to the relevant procedures specified in the protocol, and correctly understand and sign the informed consent form in writing. Exclusion Criteria: Any uncontrolled or serious disease that may interfere with participation in the clinical study and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical study. 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 40 or greater than 90 mmHg after 10 minutes of supine rest, unless determined by the Investigator to be not clinically significant. Diagnosis of diabetes mellitus, history of gestational diabetes that is fully resolved is not permitted. Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject's participation in or completion of the study. Note: additional inclusion/exclusion criteria may apply, per protocol.
Sites / Locations
- Q-Pharm Pty LimitedRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Placebo Comparator
Placebo Comparator
RBD4059 SAD experimental group
RBD4059 MAD experimental group
Placebo SAD group
Placebo MAD group
Subjects in SAD experimental groups will receive a single subcutaneous injection of RBD4059 on Day 1.
Subjects in MAD experimental groups will receive one subcutaneous injection of RBD4059 on Day 1 and another subcutaneous injection of RBD4059 on Day 29.
Subjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 1.
Subjects in MAD placebo groups will receive one subcutaneous injection of placebo on Day 1 and another subcutaneous injection of placebo on Day 29.