Safety IssuesPhase 1NCT07902245
Phase 1 Study to Evaluate RG002C0106 Injection in Healthy Participants
A Phase 1 study testing RG002C0106 and 0.9% sodium chloride injection in people with Safety Issues, run by Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd. at 1 site in Austria.
Trial summary
The goal of this clinical trial is to learn if RG002C0106 is safe in healthy participants . It will also learn about how the drug is absorbed, distributed， metablized and excrited. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- What is being tested?
- RG002C0106 and 0.9% sodium chloride injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 10 Dec 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who are able to communicate well with the investigator, understand and comply with study requirements, voluntarily participate in the study, and are able to read and sign the informed consent form (ICF);
- Healthy male or female participants aged 18-55 years (inclusive);
- At screening, judged by the investigator to be in good health based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests;
- Male participants with body weights ≥ 50 kg, female participants with body weights ≥ 45 kg, and body mass indexes (BMIs, inclusive): 18-30 kg/m2;
- Female participants of childbearing potential must have a negative pregnancy test at screening and Day -1;
- Female participants of childbearing potential or male participants with female partners of childbearing potential must agree to use a highly effective contraception during the study period (from signing the ICF) until 6 months after the dose of the study drug; they must have no plans for pregnancy or donation of sperm/eggs during the study period until 6 months after the dose of the study drug.
- Participants must be vaccinated against Neisseria meningitidis, Streptococcus pneumonia and Haemophilus influenzae type B infections within 5 years but at least 2 weeks prior to the administration of the study drug. If already vaccinated, the proof/document of vaccination must be provided.
Who cannot join
- With a specific history of allergies (such as asthma, urticaria, and eczema) or known to have multiple allergies (to 3 or more substances), or those with a known history of allergies to the investigational drug or its excipients, or those with current allergic conditions (assessed through interrogation), as judged by the investigator;
- Any significant medical conditions (e.g., involving central nervous, cardiovascular, digestive, respiratory, urinary, hematological, reproductive, immunological, endocrine systems, or psychiatric disorders) deemed unsuitable for participation in the study by the investigator;
- Special dietary requirements and cannot follow the study standardized meals (e.g., lactose intolerance, dysphagia);
- Participants with known or persistent psychiatric disorders that may interfere with participation in the study and require pharmacological intervention, as determined by the investigator, including but not limited to schizophrenia, bipolar disorder, or serious depression;
- Participants with confirmed or suspected presence of active viral, bacterial, fungal, or parasitic infections within 1 month before the screening;
- Participants with a history of recurrent or chronic infections;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Novatrials
City of Lake Macquarie, New South Wales, 2290
Karen Brennan, +61 2 4063 3381, karen@novatrials.com.au
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single-Dose Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Profile of RG002C0106 Injection in Healthy Participants
The goal of this clinical trial is to learn if RG002C0106 is safe in healthy participants . It will also learn about how the drug is absorbed, distributed， metablized and excrited. The main questions it aims to answer are:
What medical problems do participants have when taking RG002C0106? Researchers will compare RG002C0106 to a placebo (a look-alike substance that contains no drug) to see if RG002C0106 is safe to participants.
Participants will:
Take RG00C2C0106 or a placebo once. Visit the clinic once every 2 weeks/1 month for checkups and tests.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, single-dose, phase I study in healthy adult participants.
A Safety Review Committee (SRC), composed of the sponsor, the Investigator and the sponsor representatives, will be established prior to study initiation.
Escalation to the next higher dose level will only be permitted if the SRC confirms an acceptable safety and tolerability profile based on safety data and available PK/PD assessments collected.
- Conditions
- Safety Issues
- Being tested
- RG002C0106, 0.9% sodium chloride injection
- Keywords
- Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RG002C0106Drug
Also called RG002C0106 is a siRNA drug targeting complement C3 to silence the related gene through the RNA interfering mechanism and inhibit expression of C3 protein.
At Day 1, each participants will be given one dose of RG002C0106 Injection.
0.9% sodium chloride injectionDrug
Also called placebo
At Day 1, each participants will be given one dose of 0.9% sodium chloride injection.
| Study group | Role | What they receive |
|---|---|---|
| RG002C0106 injection | Experimental | Randomly enrolled subjects receiving the investigational drug will receive subcutaneous injection for administration Receives: Drug: RG002C0106 |
| 0.9% sodium chloride injection | Placebo comparator | Randomly enrolled subjects receiving 0.9% sodium chloride injection will receive subcutaneous injection for administration Receives: Drug: 0.9% sodium chloride injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidences of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug.
Incidences of adverse events (AEs) and serious adverse events (SAEs) related to the study drug
Measured: within 169 days after the administration
Secondary outcomes (6)
maximum drug concentration (Cmax)
Blood samples are collected to detect drug consentration for maximum drug concentration (Cmax)
Measured: at designed time points within three days after the administration
PD markers
Blood samples are collected to detect C3 complement protein level and activity for PD evaluation
Measured: within 365 days after the administration
Incidence of anti-drug antibodies (ADAs) against RG002C0106 Injection
Blood samples are collected to test ADA concentration to evaluate the immunogenicity.
Measured: within 113 days after the administration
time to maximum concentration (Tmax)
Blood samples are collected to detect drug consentration for time to maximum concentration (Tmax)
Measured: at designed time points within three days after the administration
area under the concentration-time curve from time zero to 48 hours post-dose
Blood samples are collected to detect drug consentration for area under the concentration-time curve from time zero to 48 hours post-dose
Measured: at designed time points within three days after the administration
elimination half-life (t1/2)
Blood samples are collected to detect drug consentration for elimination half-life (t1/2)
Measured: at designed time points within three days after the administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start10 Dec 2026 (estimated)
- Primary completion31 Mar 2028 (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 Safety IssuesStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Martin, Principal investigator, Novatrials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902245
- Sponsor's protocol ID
- RG002C0106-103
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single-Dose Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Profile of RG002C0106 Injection in Healthy Participants
- ClinicalTrials.gov ID
- NCT07902245
- Acronym / sponsor ID
- RG002C0106-103
- Conditions
- Safety Issues
- Keywords
- Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Dec 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 28 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 learn if RG002C0106 is safe in healthy participants . It will also learn about how the drug is absorbed, distributed， metablized and excrited. The main questions it aims to answer are:
What medical problems do participants have when taking RG002C0106? Researchers will compare RG002C0106 to a placebo (a look-alike substance that contains no drug) to see if RG002C0106 is safe to participants.
Participants will:
Take RG00C2C0106 or a placebo once. Visit the clinic once every 2 weeks/1 month for checkups and tests.
Detailed description
This is a randomized, double-blind, placebo-controlled, single-dose, phase I study in healthy adult participants.
A Safety Review Committee (SRC), composed of the sponsor, the Investigator and the sponsor representatives, will be established prior to study initiation.
Escalation to the next higher dose level will only be permitted if the SRC confirms an acceptable safety and tolerability profile based on safety data and available PK/PD assessments collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RG002C0106 injection | Experimental | Drug: RG002C0106Randomly enrolled subjects receiving the investigational drug will receive subcutaneous injection for administration |
| 0.9% sodium chloride injection | Placebo comparator | Drug: 0.9% sodium chloride injectionRandomly enrolled subjects receiving 0.9% sodium chloride injection will receive subcutaneous injection for administration |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants who are able to communicate well with the investigator, understand and comply with study requirements, voluntarily participate in the study, and are able to read and sign the informed consent form (ICF);
- Healthy male or female participants aged 18-55 years (inclusive);
- At screening, judged by the investigator to be in good health based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests;
- Male participants with body weights ≥ 50 kg, female participants with body weights ≥ 45 kg, and body mass indexes (BMIs, inclusive): 18-30 kg/m2;
- Female participants of childbearing potential must have a negative pregnancy test at screening and Day -1;
Key exclusion criteria (6 listed)
- With a specific history of allergies (such as asthma, urticaria, and eczema) or known to have multiple allergies (to 3 or more substances), or those with a known history of allergies to the investigational drug or its excipients, or those with current allergic conditions (assessed through interrogation), as judged by the investigator;
- Any significant medical conditions (e.g., involving central nervous, cardiovascular, digestive, respiratory, urinary, hematological, reproductive, immunological, endocrine systems, or psychiatric disorders) deemed unsuitable for participation in the study by the investigator;
- Special dietary requirements and cannot follow the study standardized meals (e.g., lactose intolerance, dysphagia);
- Participants with known or persistent psychiatric disorders that may interfere with participation in the study and require pharmacological intervention, as determined by the investigator, including but not limited to schizophrenia, bipolar disorder, or serious depression;
- Participants with confirmed or suspected presence of active viral, bacterial, fungal, or parasitic infections within 1 month before the screening;
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 |
|---|---|---|
| RG002C0106Also: RG002C0106 is a siRNA drug targeting complement C3 to silence the related gene through the RNA interfering mechanism and inhibit expression of C3 protein.At Day 1, each participants will be given one dose of RG002C0106 Injection. | Drug | RG002C0106 injection |
| 0.9% sodium chloride injectionAlso: placeboAt Day 1, each participants will be given one dose of 0.9% sodium chloride injection. | Drug | 0.9% sodium chloride injection |
Primary outcome
Incidences of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug.
Time frame: within 169 days after the administration
Incidences of adverse events (AEs) and serious adverse events (SAEs) related to the study drug
6 secondary outcomes
maximum drug concentration (Cmax)
Time frame: at designed time points within three days after the administration
PD markers
Time frame: within 365 days after the administration
Incidence of anti-drug antibodies (ADAs) against RG002C0106 Injection
Time frame: within 113 days after the administration
time to maximum concentration (Tmax)
Time frame: at designed time points within three days after the administration
area under the concentration-time curve from time zero to 48 hours post-dose
Time frame: at designed time points within three days after the administration
elimination half-life (t1/2)
Time frame: at designed time points within three days after the administration
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 28 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.
Jennifer Martin principal investigator
Novatrials
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 RG002C0106 and 0.9% sodium chloride injection in people with Safety Issues, run by Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd. at 1 site in Austria.
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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 28 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 Austria. 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 Zhu Lingling Zhu (8610-63729218, llzhu@rigerna.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidences of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug. (time frame: within 169 days after the administration). 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 28 Oct 2026.