NCT07869940 First-in-human Trial of RBD2080 in Healthy Participants
| NCT ID | NCT07869940 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Suzhou Ribo Life Science Co. Ltd. |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-08-19 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2026-08-19 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Key Inclusion Criteria: 1. Willing and able to give written informed consent for participation in the trial. 2. Healthy male or female participant aged 18 to 50 years. 3. BMI ≥ 18 and ≤ 32.0 kg/m2 at the time of the screening period. 4. 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. 5. 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: 1. 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. 2. Known or suspected hereditary asymptomatic complement deficiency. 3. Any clinically significant illness, medical/surgical procedure, or trauma within four weeks of the first administration of IMP. 4. Malignancy within the past five years, with the exception of in situ removal of basal cell carcinoma. 5. Any planned major surgery within the duration of the trial. 6. Extensive tattoos covering all potential injection areas, extensive scarring, or other barriers to subcutaneous injection, as judged by the investigator. 7. Participants who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial. 8. 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.
Contact & Investigator
Natasha Martin, PhD
PRINCIPAL INVESTIGATOR
CMAX Clinical Research
Frequently Asked Questions
Who can join the NCT07869940 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07869940 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07869940 currently recruiting?
Yes, NCT07869940 is actively recruiting participants. Contact the research team at Natasha.Martin@cmax.com.au for enrollment information.
Where is the NCT07869940 trial being conducted?
This trial is being conducted at Adelaide, Australia.
Who is sponsoring the NCT07869940 clinical trial?
NCT07869940 is sponsored by Suzhou Ribo Life Science Co. Ltd.. The principal investigator is Natasha Martin, PhD at CMAX Clinical Research. The trial plans to enroll 24 participants.