First-in-human Trial of RBD2080 in Healthy Participants

NCT07869940 | Recruiting Phase 1

• 2 other identifiers: RBC31101EC00372
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Phase 1

Outcome Measures

Primary Outcomes (1)

• Frequency, severity, and seriousness of reported adverse events (AEs)

  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)

  After day 85 post dose (Part A) and day 113 post first dose (Part B)

• Pharmacokinetic parameters for RBD2080

  Day1, 2, 3

• Change from baseline in levels of C3 protein

  Day -1, 1, 3, 8, 15, 22, 29, 57, 85, 113, 169, 225, 281, 365

Study Arms (4)

RBD2080 SAD experimental group

EXPERIMENTAL

Participants in SAD experimental groups will receive a single subcutaneous injection of RBD2080.

Drug: RBD2080

Placebo SAD group

PLACEBO COMPARATOR

Participants in SAD placebo groups will receive a single subcutaneous injection of placebo.

Drug: Placebo

RBD2080 MAD experimental group

EXPERIMENTAL

Participants in MAD experimental groups will receive multiple subcutaneous injections of RBD2080.

Drug: RBD2080

Experimental Placebo Comparator: Placebo MAD group

PLACEBO COMPARATOR

Participants in MAD placebo groups will receive multiple subcutaneous injections of placebo.

Drug: Placebo

Interventions

Placebo DRUG

Subcutaneously Administered placebo in Healthy Subjects

Experimental Placebo Comparator: Placebo MAD group; Placebo SAD group

RBD2080 DRUG

Subcutaneously Administered RBD2080 in Healthy Subjects

RBD2080 MAD experimental group; RBD2080 SAD experimental group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Ribo Life Science Co. Ltd.: lead
• Ribocure Pharmaceuticals AB: collaborator

Study Sites (1)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

RECRUITING

Study Officials

• Natasha Martin, PhD

  CMAX Clinical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natasha Martin, PhD

CONTACT

+61420456887; Natasha.Martin@cmax.com.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: October 13, 2026
• Study Start: August 19, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: October 13, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)