- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05653037
A Single Ascending Doses Phase I Study to Evaluate the Safety and Pharmacokinetics of RBD4059 in Healthy Subjects
A Randomized, Single-blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of Subcutaneously Administered RBD4059 in Healthy Subjects
This is a Randomized, Single-blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of Subcutaneously Administered RBD4059 in Healthy Subjects. The study will be performed in single ascending dose (SAD) phase in healthy subjects. The decision to escalate to subsequent dose levels will be made by the SRC based on the review of all available safety information and PK/PD data in each cohort.
RBD4059, a GalNAc conjugated siRNA, is an FXI-targeted new molecular entity independently developed by Ribo using its proprietary siRNA delivery system - RIBO-GalSTARTM.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
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Brisbane, Australia
- Recruiting
- Q-Pharm Pty Limited
-
Contact:
- Priyanka meet
- Phone Number: +61 430 316 033
- Email: p.meet@nucleusnetwork.com.au
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RBD4059 SAD experimental group
Subjects in SAD experimental groups will receive a single subcutaneous injection of RBD4059 on Day 1.
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Subcutaneously Administered RBD4059 in Healthy Subjects.
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Placebo Comparator: Placebo SAD group
Subjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 1.
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Subcutaneously Administered Placebo in Healthys Subject.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
Time Frame: SAD: Up to Day 169 ;
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SAD: Up to Day 169 ;
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:Cmax
Time Frame: Up to 48 hours post-dose
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Up to 48 hours post-dose
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To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:Tmax
Time Frame: Up to 48 hours post-dose
|
Up to 48 hours post-dose
|
To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:AUC0-t
Time Frame: Up to 48 hours post-dose
|
Up to 48 hours post-dose
|
To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:AUC0-inf
Time Frame: Up to 48 hours post-dose
|
Up to 48 hours post-dose
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To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:t1/2
Time Frame: Up to 48 hours post-dose
|
Up to 48 hours post-dose
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To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:MRT
Time Frame: Up to 48 hours post-dose
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Up to 48 hours post-dose
|
To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:λz
Time Frame: Up to 48 hours post-dose
|
Up to 48 hours post-dose
|
To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:CL/F
Time Frame: Up to 48 hours post-dose
|
Up to 48 hours post-dose
|
To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:Vz
Time Frame: Up to 48 hours post-dose
|
Up to 48 hours post-dose
|
To evaluate the pharmacodynamics (PD) effect of RBD4059 on levels of Coagulation factor XI (FXI) antigen in healthy subjects.
Time Frame: SAD: Up to Day 169 ;
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SAD: Up to Day 169 ;
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To evaluate the pharmacodynamics (PD) effect of RBD4059 on levels of FXI activity in healthy subjects.
Time Frame: SAD: Up to Day 169 ;
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SAD: Up to Day 169 ;
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To evaluate the pharmacodynamics (PD) effect of RBD4059 on levels of Activated partial thromboplastin time (APTT) in healthy subjects.
Time Frame: SAD: Up to Day 169 ;
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SAD: Up to Day 169 ;
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RBFI1101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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