Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05653037




Registration number
NCT05653037
Ethics application status
Date submitted
21/11/2022
Date registered
16/12/2022
Date last updated
28/02/2024

Titles & IDs
Public title
A Single Ascending Doses Phase I Study to Evaluate the Safety and Pharmacokinetics of RBD4059 in Healthy Subjects
Scientific title
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
Secondary ID [1] 0 0
RBFI1101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RBD4059
Treatment: Drugs - Placebo

Experimental: RBD4059 SAD experimental group - Subjects in SAD experimental groups will receive a single subcutaneous injection of RBD4059 on Day 1.

Placebo comparator: Placebo SAD group - Subjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 1.


Treatment: Drugs: RBD4059
Subcutaneously Administered RBD4059 in Healthy Subjects.

Treatment: Drugs: Placebo
Subcutaneously Administered Placebo in Healthys Subject.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
Timepoint [1] 0 0
SAD: Up to Day 169 ;
Secondary outcome [1] 0 0
To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:Cmax
Timepoint [1] 0 0
Up to 48 hours post-dose
Secondary outcome [2] 0 0
To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:Tmax
Timepoint [2] 0 0
Up to 48 hours post-dose
Secondary outcome [3] 0 0
To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:AUC0-t
Timepoint [3] 0 0
Up to 48 hours post-dose
Secondary outcome [4] 0 0
To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:AUC0-inf
Timepoint [4] 0 0
Up to 48 hours post-dose
Secondary outcome [5] 0 0
To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:t1/2
Timepoint [5] 0 0
Up to 48 hours post-dose
Secondary outcome [6] 0 0
To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:MRT
Timepoint [6] 0 0
Up to 48 hours post-dose
Secondary outcome [7] 0 0
To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:?z
Timepoint [7] 0 0
Up to 48 hours post-dose
Secondary outcome [8] 0 0
To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:CL/F
Timepoint [8] 0 0
Up to 48 hours post-dose
Secondary outcome [9] 0 0
To characterize the pharmacokinetics (PK) of RBD4059 in healthy subjects:Vz
Timepoint [9] 0 0
Up to 48 hours post-dose
Secondary outcome [10] 0 0
To evaluate the pharmacodynamics (PD) effect of RBD4059 on levels of Coagulation factor XI (FXI) antigen in healthy subjects.
Timepoint [10] 0 0
SAD: Up to Day 169 ;
Secondary outcome [11] 0 0
To evaluate the pharmacodynamics (PD) effect of RBD4059 on levels of FXI activity in healthy subjects.
Timepoint [11] 0 0
SAD: Up to Day 169 ;
Secondary outcome [12] 0 0
To evaluate the pharmacodynamics (PD) effect of RBD4059 on levels of Activated partial thromboplastin time (APTT) in healthy subjects.
Timepoint [12] 0 0
SAD: Up to Day 169 ;

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Q-Pharm Pty Limited - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Suzhou Ribo Life Science Co. Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05653037