A Single Ascending Doses Phase I Study to Evaluate the Safety and Pharmacokinetics of RBD4059 in Healthy Subjects

Launched by SUZHOU RIBO LIFE SCIENCE CO. LTD. · Dec 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called RBD4059, which is designed to target a specific protein in the blood that plays a role in clotting. The purpose of the study is to evaluate the safety of this treatment, how well it is tolerated, and how it is processed in the body when given in increasing doses. The trial is being conducted with healthy volunteers, meaning that participants should be in good health with no serious medical conditions that could interfere with the study.

To be eligible for this trial, participants must be between 18 and 65 years old, have a body weight within a specific range, and pass several health screenings to ensure they are healthy. Participants will receive the treatment through a small injection under the skin and will be monitored closely to check for any side effects or reactions. This study is currently recruiting participants, and those who take part will help researchers understand more about this new treatment and how it might be used in the future.

Gender

ALL

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.