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

PHASE1RECRUITING

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.

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Study details:

RBD4059, a GalNAc conjugated siRNA, is an FXI-targeted new molecular entity independently developed by Ribo using its proprietary siRNA delivery system - RIBO-GalSTARTM. As a GalNAc-based liver targeting delivery system, RIBO-GalSTARTM incorporates a unique technology for the delivery of oligonucleotide therapeutics for various targets and indications associated with the liver, thus enabling highly specific and highly durable enrichment of the siRNA in hepatocytes, the primary source of FXI. RBD4059 is, therefore, proposed to be a novel effective and durable antithrombotic treatment, with low bleeding risk via inhibition of FXI activity and prolongation of APTT.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-03-21

Primary completion: 2024-10-01

Study completion finish: 2024-12-01

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT05653037

Intervention or treatment

DRUG: RBD4059

DRUG: Placebo

Conditions

• Healthy Volunteers

Condition: Healthy Volunteers
DRUG: RBD4059 and other drugs
Brisbane, Not Specified, Australia
Sponsor: Suzhou Ribo Life Science Co. Ltd.

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Find a site

Closest Location:

Q-Pharm Pty Limited

Research sites nearby

Select from list below to view details:

Q-Pharm Pty Limited
Brisbane, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

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.	DRUG: RBD4059 Subcutaneously Administered RBD4059 in Healthy Subjects.
PLACEBO_COMPARATOR: Placebo SAD group Subjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 1.	DRUG: Placebo Subcutaneously Administered Placebo in Healthys Subject.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0	Not Specified	SAD: Up to Day 169 ;

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:Cmax	Not Specified	Up to 48 hours post-dose
To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:Tmax	Not Specified	Up to 48 hours post-dose
To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:AUC0-t	Not Specified	Up to 48 hours post-dose
To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:AUC0-inf	Not Specified	Up to 48 hours post-dose
To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:t1/2	Not Specified	Up to 48 hours post-dose
To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:MRT	Not Specified	Up to 48 hours post-dose
To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:λz	Not Specified	Up to 48 hours post-dose
To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:CL/F	Not Specified	Up to 48 hours post-dose
To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:Vz	Not Specified	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.	Not Specified	SAD: Up to Day 169 ;
To evaluate the pharmacodynamics (PD) effect of RBD4059 on levels of FXI activity in healthy subjects.	Not Specified	SAD: Up to Day 169 ;
To evaluate the pharmacodynamics (PD) effect of RBD4059 on levels of Activated partial thromboplastin time (APTT) in healthy subjects.	Not Specified	SAD: Up to Day 169 ;

Frequently Asked Questions

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References

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