Healthy VolunteersPhase 1NCT07042594
Single Ascending Doses Phase I Study to Evaluate the Safety and Pharmacokinetics of RBD1119 in Healthy Participants
A Phase 1 study testing RBD1119 in people with Healthy Volunteers, run by Suzhou Ribo Life Science Co. Ltd. at 1 site in Australia.
Trial summary
This is 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- RBD1119
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 26 Aug 2025to Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Main Inclusion Criteria:
- 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 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
This is 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.
- Conditions
- Healthy Volunteers
- Being tested
- RBD1119, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBD1119Drug
Subcutaneously Administered RBD1119 in Healthy Subjects.
PlaceboDrug
Subcutaneously Administered Placebo in Healthy Subject.
| Study group | Role | What they receive |
|---|---|---|
| RBD1119 SAD experimental group | Experimental | Subjects in SAD experimental groups will receive a single subcutaneous injection of RBD1119 on Day 1. Receives: Drug: RBD1119 |
| Placebo SAD group | Placebo comparator | Subjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 1 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
Measured: Up to Day 85
Secondary outcomes (9)
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
Measured: After day 85
To characterize the pharmacokinetics (PK) as maximum plasma concentration (Cmax) of RBD1119 in healthy participants
Measured: Up to 48 hours post-dose
To evaluate the pharmacodynamics (PD) effect of RBD1119 as percentage change from baseline in intrinsic coagulation pathway related antigen levels in healthy participants.
Measured: Up to Day 169.
To characterize the pharmacokinetics (PK) as Time to reach Cmax (Tmax) of RBD1119 in healthy participants
Measured: Up to 48 hours post-dose
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
Measured: Up to 48 hours post-dose
To characterize the pharmacokinetics (PK) as area under the plasma concentration-time from time zero to infinity (AUC0-inf) of RBD1119 in healthy participants
Measured: Up to 48 hours post-dose
To characterize the pharmacokinetics (PK) as apparent terminal elimination half-life (t1/2) of RBD1119 in healthy participants
Measured: Up to 48 hours post-dose
To evaluate the pharmacodynamics (PD) effect of RBD1119 as percentage change from baseline in intrinsic coagulation pathway related activity levels in healthy participants.
Measured: Up to Day 169.
To evaluate the pharmacodynamics (PD) effect of RBD1119 as percentage change from baseline in APTT in healthy participants.
Measured: Up to Day 169.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start26 Aug 2025
- Primary completion5 Aug 2026
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Ribo Life Science Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042594
- Sponsor's protocol ID
- RBFI2101
- Status last verified
- Sep 2026
- First submitted
- 13 Jun 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07042594
- Acronym / sponsor ID
- RBFI2101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Suzhou Ribo Life Science Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- 5 Aug 2026 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RBD1119 SAD experimental group | Experimental | Drug: RBD1119Subjects in SAD experimental groups will receive a single subcutaneous injection of RBD1119 on Day 1. |
| Placebo SAD group | Placebo comparator | Drug: PlaceboSubjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RBD1119Subcutaneously Administered RBD1119 in Healthy Subjects. | Drug | RBD1119 SAD experimental group |
| PlaceboSubcutaneously Administered Placebo in Healthy Subject. | Drug | Placebo SAD group |
Primary outcome
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
Time frame: Up to Day 85
9 secondary outcomes
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
Time frame: After day 85
To characterize the pharmacokinetics (PK) as maximum plasma concentration (Cmax) of RBD1119 in healthy participants
Time frame: Up to 48 hours post-dose
To evaluate the pharmacodynamics (PD) effect of RBD1119 as percentage change from baseline in intrinsic coagulation pathway related antigen levels in healthy participants.
Time frame: Up to Day 169.
To characterize the pharmacokinetics (PK) as Time to reach Cmax (Tmax) of RBD1119 in healthy participants
Time frame: Up to 48 hours post-dose
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
Time frame: Up to 48 hours post-dose
To characterize the pharmacokinetics (PK) as area under the plasma concentration-time from time zero to infinity (AUC0-inf) of RBD1119 in healthy participants
Time frame: Up to 48 hours post-dose
To characterize the pharmacokinetics (PK) as apparent terminal elimination half-life (t1/2) of RBD1119 in healthy participants
Time frame: Up to 48 hours post-dose
To evaluate the pharmacodynamics (PD) effect of RBD1119 as percentage change from baseline in intrinsic coagulation pathway related activity levels in healthy participants.
Time frame: Up to Day 169.
To evaluate the pharmacodynamics (PD) effect of RBD1119 as percentage change from baseline in APTT in healthy participants.
Time frame: Up to Day 169.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RBD1119 in people with Healthy Volunteers, run by Suzhou Ribo Life Science Co. Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0 (time frame: Up to Day 85). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.