HealthyPhase 1NCT07869940
First-in-human Trial of RBD2080 in Healthy Participants
A Phase 1 study testing RBD2080 in people with Healthy, run by Suzhou Ribo Life Science Co. Ltd. at 1 site in Australia.
Trial summary
The goal of this clinical trial is to evaluate the safety, tolerability, dose-dependent pharmacokinetics and pharmacodynamics effects of RBD2080 in healthy volunteers to inform its further development for the treatment of patients with complement-mediated diseases. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- RBD2080
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 19 Aug 2026to 31 Mar 2028
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to give written informed consent for participation in the trial.
- Healthy male or female participant aged 18 to 50 years.
- BMI ≥ 18 and ≤ 32.0 kg/m2 at the time of the screening period.
- Medically healthy without abnormal clinically significant medical/surgical history, physical findings, vital signs, ECG, and laboratory values at the time of the screening period, as judged by the Investigator.
- Vaccinated against meningococcal disease (caused by Neisseria meningitidis) with a meningococcal ACWY conjugate vaccine and a serogroup B vaccine, or willing to be vaccinated against meningococcal disease, Streptococcus pneumoniae vaccine, Haemophilus influenzae type B vaccine during the screening period of the trial.
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant's ability to participate in the trial.
- Known or suspected hereditary asymptomatic complement deficiency.
- Any clinically significant illness, medical/surgical procedure, or trauma within four weeks of the first administration of IMP.
- Malignancy within the past five years, with the exception of in situ removal of basal cell carcinoma.
- Any planned major surgery within the duration of the trial.
- Extensive tattoos covering all potential injection areas, extensive scarring, or other barriers to subcutaneous injection, as judged by the investigator.
- Participants who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial.
- At community risk for contracting meningococcal/ pneumococcal/Hib disease, at the discretion of the Investigator. Including recent contact with meningococcal disease and/or recent travel to risk areas for meningococcal disease contagion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
CMAX Clinical Research
Adelaide, South Australia, 5000
Jane Kelly, +61 0870887900, cmax@cmax.com.au
About this study
Official title: A Phase 1, Randomized, Single-blind, Single-center, Placebo-controlled First-in-human Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RBD2080 in Healthy Participants
The goal of this clinical trial is to evaluate the safety, tolerability, dose-dependent pharmacokinetics and pharmacodynamics effects of RBD2080 in healthy volunteers to inform its further development for the treatment of patients with complement-mediated diseases.
Participants will:
- Be vaccinated against encapsulated bacterial infection prior to any IMP administration
- Receive single or multiple doses of RBD2080 or placebo and attend 10-11 visits to the trial site for checkups and tests until End of trial (EoT).
- Following End of trial visit, participants may enter an open-label follow-up period consisting of additional outpatient visits.
- Conditions
- Healthy
- Being tested
- Placebo, RBD2080
- Keywords
- Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Subcutaneously Administered placebo in Healthy Subjects
RBD2080Drug
Subcutaneously Administered RBD2080 in Healthy Subjects
| Study group | Role | What they receive |
|---|---|---|
| RBD2080 SAD experimental group | Experimental | Participants in SAD experimental groups will receive a single subcutaneous injection of RBD2080. Receives: Drug: RBD2080 |
| Placebo SAD group | Placebo comparator | Participants in SAD placebo groups will receive a single subcutaneous injection of placebo. Receives: Drug: Placebo |
| RBD2080 MAD experimental group | Experimental | Participants in MAD experimental groups will receive multiple subcutaneous injections of RBD2080. Receives: Drug: RBD2080 |
| Experimental Placebo Comparator: Placebo MAD group | Placebo comparator | Participants in MAD placebo groups will receive multiple subcutaneous injections of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency, severity, and seriousness of reported adverse events (AEs)
Measured: From enrollment up until day 85 post dose (Part A) and day 113 post first dose (Part B)
Secondary outcomes (3)
The Safety and tolerability of RBD2080 after day 85 post dose (part A), and after day 113 post dose (part B) incl. frequency, severity, and seriousness of reported adverse events (AEs)
Number of AEs recorded (incl grading severity and seriousness)
Measured: After day 85 post dose (Part A) and day 113 post first dose (Part B)
Pharmacokinetic parameters for RBD2080
Plasma concentrations up until 48 hours after injection.
Measured: Day1, 2, 3
Change from baseline in levels of C3 protein
Change in plasma concentration of C3 protein from baseline day 169 part A, Day 197 Part B.
Measured: Day -1, 1, 3, 8, 15, 22, 29, 57, 85, 113, 169, 225, 281, 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start19 Aug 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Ribo Life Science Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ribocure Pharmaceuticals AB
- Responsible party
- Sponsor
- Investigators
- Natasha Martin, PhD, Principal investigator, CMAX Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869940
- Sponsor's protocol ID
- RBC31101
- Other IDs
- EC00372
- Status last verified
- Oct 2026
- First submitted
- 20 Jul 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Single-blind, Single-center, Placebo-controlled First-in-human Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RBD2080 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07869940
- Acronym / sponsor ID
- RBC31101
- Conditions
- Healthy
- Keywords
- Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Suzhou Ribo Life Science Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Ribocure Pharmaceuticals AB
- Study start
- 19 Aug 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 13 Oct 2026 (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.
The goal of this clinical trial is to evaluate the safety, tolerability, dose-dependent pharmacokinetics and pharmacodynamics effects of RBD2080 in healthy volunteers to inform its further development for the treatment of patients with complement-mediated diseases.
Participants will:
- Be vaccinated against encapsulated bacterial infection prior to any IMP administration
- Receive single or multiple doses of RBD2080 or placebo and attend 10-11 visits to the trial site for checkups and tests until End of trial (EoT).
- Following End of trial visit, participants may enter an open-label follow-up period consisting of additional outpatient visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RBD2080 SAD experimental group | Experimental | Drug: RBD2080Participants in SAD experimental groups will receive a single subcutaneous injection of RBD2080. |
| Placebo SAD group | Placebo comparator | Drug: PlaceboParticipants in SAD placebo groups will receive a single subcutaneous injection of placebo. |
| RBD2080 MAD experimental group | Experimental | Drug: RBD2080Participants in MAD experimental groups will receive multiple subcutaneous injections of RBD2080. |
| Experimental Placebo Comparator: Placebo MAD group | Placebo comparator | Drug: PlaceboParticipants in MAD placebo groups will receive multiple subcutaneous injections of placebo. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Willing and able to give written informed consent for participation in the trial.
- Healthy male or female participant aged 18 to 50 years.
- BMI ≥ 18 and ≤ 32.0 kg/m2 at the time of the screening period.
- Medically healthy without abnormal clinically significant medical/surgical history, physical findings, vital signs, ECG, and laboratory values at the time of the screening period, as judged by the Investigator.
- Vaccinated against meningococcal disease (caused by Neisseria meningitidis) with a meningococcal ACWY conjugate vaccine and a serogroup B vaccine, or willing to be vaccinated against meningococcal disease, Streptococcus pneumoniae vaccine, Haemophilus influenzae type B vaccine during the screening period of the trial.
Key exclusion criteria (8 listed)
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant's ability to participate in the trial.
- Known or suspected hereditary asymptomatic complement deficiency.
- Any clinically significant illness, medical/surgical procedure, or trauma within four weeks of the first administration of IMP.
- Malignancy within the past five years, with the exception of in situ removal of basal cell carcinoma.
- Any planned major surgery within the duration of the trial.
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 |
|---|---|---|
| PlaceboSubcutaneously Administered placebo in Healthy Subjects | Drug | Experimental Placebo Comparator: Placebo MAD group, Placebo SAD group |
| RBD2080Subcutaneously Administered RBD2080 in Healthy Subjects | Drug | RBD2080 MAD experimental group, RBD2080 SAD experimental group |
Primary outcome
Frequency, severity, and seriousness of reported adverse events (AEs)
Time frame: From enrollment up until day 85 post dose (Part A) and day 113 post first dose (Part B)
3 secondary outcomes
The Safety and tolerability of RBD2080 after day 85 post dose (part A), and after day 113 post dose (part B) incl. frequency, severity, and seriousness of reported adverse events (AEs)
Time frame: After day 85 post dose (Part A) and day 113 post first dose (Part B)
Pharmacokinetic parameters for RBD2080
Time frame: Day1, 2, 3
Change from baseline in levels of C3 protein
Time frame: Day -1, 1, 3, 8, 15, 22, 29, 57, 85, 113, 169, 225, 281, 365
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 13 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Natasha Martin, PhD principal investigator
CMAX Clinical Research
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 RBD2080 in people with Healthy, 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?
The sponsor lists 5 inclusion and 8 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 13 Oct 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?
Contact Natasha Martin, PhD (+61420456887, Natasha.Martin@cmax.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency, severity, and seriousness of reported adverse events (AEs) (time frame: From enrollment up until day 85 post dose (Part A) and day 113 post first dose (Part B)). 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 13 Oct 2026.