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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07042594




Registration number
NCT07042594
Ethics application status
Date submitted
13/06/2025
Date registered
29/06/2025
Date last updated
29/06/2025

Titles & IDs
Public title
Single Ascending Doses Phase I Study to Evaluate the Safety and Pharmacokinetics of RBD1119 in Healthy Participants
Scientific title
A Randomized, Single-blind, Placebo-Controlled Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of Subcutaneously Administered RBD1119 in Healthy Participants
Secondary ID [1] 0 0
RBFI2101
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 - RBD1119
Treatment: Drugs - Placebo

Experimental: RBD1119 SAD experimental group - Subjects in SAD experimental groups will receive a single subcutaneous injection of RBD1119 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: RBD1119
Subcutaneously Administered RBD1119 in Healthy Subjects.

Treatment: Drugs: Placebo
Subcutaneously Administered Placebo in Healthy 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
Up to Day 85
Secondary outcome [1] 0 0
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
Timepoint [1] 0 0
After day 85
Secondary outcome [2] 0 0
To characterize the pharmacokinetics (PK) as maximum plasma concentration (Cmax) of RBD1119 in healthy participants
Timepoint [2] 0 0
Up to 48 hours post-dose
Secondary outcome [3] 0 0
To evaluate the pharmacodynamics (PD) effect of RBD1119 as percentage change from baseline in intrinsic coagulation pathway related antigen levels in healthy participants.
Timepoint [3] 0 0
Up to Day 169.
Secondary outcome [4] 0 0
To characterize the pharmacokinetics (PK) as Time to reach Cmax (Tmax) of RBD1119 in healthy participants
Timepoint [4] 0 0
Up to 48 hours post-dose
Secondary outcome [5] 0 0
To characterize the pharmacokinetics (PK) as area under the plasma concentration-time curve from the time zero to the last measurable concentration (AUC0-t) of RBD1119 in healthy participants
Timepoint [5] 0 0
Up to 48 hours post-dose
Secondary outcome [6] 0 0
To characterize the pharmacokinetics (PK) as area under the plasma concentration-time from time zero to infinity (AUC0-inf) of RBD1119 in healthy participants
Timepoint [6] 0 0
Up to 48 hours post-dose
Secondary outcome [7] 0 0
To characterize the pharmacokinetics (PK) as apparent terminal elimination half-life (t1/2) of RBD1119 in healthy participants
Timepoint [7] 0 0
Up to 48 hours post-dose
Secondary outcome [8] 0 0
To evaluate the pharmacodynamics (PD) effect of RBD1119 as percentage change from baseline in intrinsic coagulation pathway related activity levels in healthy participants.
Timepoint [8] 0 0
Up to Day 169.
Secondary outcome [9] 0 0
To evaluate the pharmacodynamics (PD) effect of RBD1119 as percentage change from baseline in APTT in healthy participants.
Timepoint [9] 0 0
Up to Day 169.

Eligibility
Key inclusion criteria
Main

* Male or female healthy participants (non-childbearing potential only), aged 18 to 65 years at screening, inclusive.
* Body mass index (BMI) between 18 and 32 kg/m2, inclusive
* APTT, Prothrombin time (PT), INR, thrombin time (TT) within normal reference range (as per the local laboratory).
* Haematology results within normal range, unless deemed not clinically significant by the Principal Investigator or delegate. Platelet count however must be within normal range per the local laboratory reference ranges.
* Healthy as determined by no clinically significant findings by the Principal Investigator or delegate in medical history, vital signs, physical examination, clinical laboratory assessments, and 12-lead electrocardiogram (ECG).

Main
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 trial and/or put the participant at significant risk (according to Principal Investigator or delegate's judgment) if he/she participates in the clinical trial.
* 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 50 or greater than 95 mmHg after 10 minutes of supine rest, unless determined by the Principal Investigator or delegate to be not clinically significant.
* Diagnosis of diabetes mellitus, history of gestational diabetes that has not been fully resolved is not permitted.
* History or presence of:

* Bleeding disorder(s) and/or at risk of bleeding, including relevant familial history, such as Hemophilia A, Hemophilia B, Wiskott-Aldrich syndrome, von Willebrand disease (vWD);
* Clinically significant anemia, in the opinion of the Principal Investigator or delegate;
* Thromboembolic diseases;
* Bleeding in the gastrointestinal tract or central nervous system;
* Anticipated need for oral surgery or tooth extractions during the trial period;
* Bleeding in the genitourinary tract;
* Gum disease or active gum bleeding;
* Planned surgery during the trial period.

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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
CMAX Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

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
Anders Gabrielsen, MD
Address 0 0
Suzhou Ribo Life Science Co. Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Mohamed Bakra, MD
Address 0 0
Country 0 0
Phone 0 0
+61(0)8 7088 7900
Fax 0 0
Email 0 0
[email protected]
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/NCT07042594