Safety IssuesPhase 1NCT06494527
A Phase 1 Study to Evaluate the Safety/Tolerability, PK/PD of RG002C0106 Injection in Healthy Adults
A Phase 1 study testing RG002C0106 in people with Safety Issues, run by Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and PK/PD profiles of RG002C0106 injection in healthy adult subjects. The study will be divided into the following parts: Part A, conducted : SAD stage Part B, conducted: MAD stage Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- What is being tested?
- RG002C0106
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2024to 10 Aug 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who are able to communicate well with the investigator, understand and follow trial requirements, voluntarily participate in the trial, understand and sign Informed Consent Form (ICF);
- Healthy adult subjects aged 18 to 60 years (inclusive), male or female;
- BMI18-32 kg/m2 ;
- Subjects who have no current or past medical history of clinically significant diseases of the circulatory system, digestive system, nervous system, respiratory system, and urinary system, mental disorders, or metabolic disorders or history of such disease; and whose physical examination, vital signs, electrocardiogram, chest X-ray or blood test and laboratory tests show normal results or abnormal but not clinically significant results (subject to clinical judgment) at the time of screening.
- WOCBP must have a negative serum pregnancy test and must not be breastfeeding, lactating or planning pregnancy during the study period.
- A male subject with a female partner of childbearing potential is eligible to participate if he agrees to use acceptable contraception during the treatment period.
- Evidence of vaccination (medical record and/or positive antibody test) against Neisseria meningitidis infection (types A, C, W and Y and Group B), Streptococcus pneumoniae, and Haemophilus influenzae type b infection is required before initiation of the investigational drug or placebo.
Who cannot join
- Known or persistent mental disorders that require medication intervention and may interfere with the subject's participation in the study.
- Presence or suspicion of active viral, bacterial, fungal or parasitic infections;
- History of recurrent or chronic infections;
- History of epidemic meningococcal infection;
- History of splenectomy or asplenia;
- History of complement abnormalities or hereditary complement deficiencies;
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- Any skin conditions and/or tattoos that may interfere with the safety assessment of the injection site, or any relevant history of abdominal scar (surgery, burns, etc.);
- Subjects who have tested positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, and treponema pallidum antibody (optional );
- Hepatic function abnormal.
- Renal function abnormal.
- Allergic condition (allergy to multiple drugs and food) or a known history of allergic reactions to oligonucleotides or hypersensitivity to subcutaneous injections;
- Subjects who participate in other interventional clinical studies and receive interventional therapy within 30 days before the first dose of the study drug in this study or within the 5 half-lives of the study drug (including investigational drugs and investigational devices) in other interventional clinical studies, whichever is longer.
- Subjects with history of drug abuse within 12 months.
- Use of non-prescription drugs within 14 days prior to the first dose of the study drug or within the 5 half-lives of the non-prescription drugs (whichever is longer), unless the investigator determines that the medication is not clinically significant.
- Subjects who have consumed more than 14 units of alcohol per week.
- Heavy smoker.
- Subjects who have donated or lost blood ≥ 480 mL within 3 months.
- Subjects who have tested positive for pregnancy test; lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 101125
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single/Multiple Ascending Dose, Phase 1 International Multi-center Clinical Study to Evaluate the Safety/Tolerability, Pharmacokinetics/Pharmacodynamics of RG002C0106 Injection in Healthy Adults
This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and PK/PD profiles of RG002C0106 injection in healthy adult subjects. The study will be divided into the following parts:
Part A, conducted : SAD stage Part B, conducted: MAD stage
Read the detailed description
This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and PK/PD profiles of RG002C0106 injection in healthy adult subjects. The study will be divided into the following parts:
Part A, conducted : SAD stage Part B, conducted: MAD stage There are 5 cohorts for the SAD escalation scheme. Dose escalation will start with the planned lowest dose 25mg，and the highest dose will be mainly determined based on the data obtained during the study process.
There are 3 cohorts for the MAD stage .The doses for these 3 cohorts are low dose, medium dose, and high dose, respectively.
- Conditions
- Safety Issues
- Being tested
- RG002C0106
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RG002C0106Drug
RG002C0106 is a siRNA drug targeting complement C3 to silence the related gene through the RNA interfering mechanism and inhibit the expression of C3 protein.
| Study group | Role | What they receive |
|---|---|---|
| RG002C0106 | Experimental | Randomly enrolled subjects receiving the investigational drug will receive subcutaneous injection for administration Receives: Drug: RG002C0106 |
| placebo | Placebo comparator | Randomly enrolled subjects receiving placebo will receive subcutaneous injection for administration Receives: Drug: RG002C0106 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug
Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug
Measured: up to 169 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start18 Oct 2024
- Primary completion6 Aug 2026
- Study completion10 Aug 2026
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494527
- Sponsor's protocol ID
- RG002C0106-001
- Status last verified
- Oct 2026
- First submitted
- 2 Jul 2024
- Last updated
- 15 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single/Multiple Ascending Dose, Phase 1 International Multi-center Clinical Study to Evaluate the Safety/Tolerability, Pharmacokinetics/Pharmacodynamics of RG002C0106 Injection in Healthy Adults
- ClinicalTrials.gov ID
- NCT06494527
- Acronym / sponsor ID
- RG002C0106-001
- Conditions
- Safety Issues
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- 6 Aug 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 10 Jul 2024 (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, double-blind, placebo-controlled study to evaluate the safety, tolerability and PK/PD profiles of RG002C0106 injection in healthy adult subjects. The study will be divided into the following parts:
Part A, conducted : SAD stage Part B, conducted: MAD stage
Detailed description
This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and PK/PD profiles of RG002C0106 injection in healthy adult subjects. The study will be divided into the following parts:
Part A, conducted : SAD stage Part B, conducted: MAD stage There are 5 cohorts for the SAD escalation scheme. Dose escalation will start with the planned lowest dose 25mg，and the highest dose will be mainly determined based on the data obtained during the study process.
There are 3 cohorts for the MAD stage .The doses for these 3 cohorts are low dose, medium dose, and high dose, respectively.
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 | Experimental | Drug: RG002C0106Randomly enrolled subjects receiving the investigational drug will receive subcutaneous injection for administration |
| placebo | Placebo comparator | Drug: RG002C0106Randomly enrolled subjects receiving placebo will receive subcutaneous injection for administration |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects who are able to communicate well with the investigator, understand and follow trial requirements, voluntarily participate in the trial, understand and sign Informed Consent Form (ICF);
- Healthy adult subjects aged 18 to 60 years (inclusive), male or female;
- BMI18-32 kg/m2 ;
- Subjects who have no current or past medical history of clinically significant diseases of the circulatory system, digestive system, nervous system, respiratory system, and urinary system, mental disorders, or metabolic disorders or history of such disease; and whose physical examination, vital signs, electrocardiogram, chest X-ray or blood test and laboratory tests show normal results or abnormal but not clinically significant results (subject to clinical judgment) at the time of screening.
- WOCBP must have a negative serum pregnancy test and must not be breastfeeding, lactating or planning pregnancy during the study period.
Key exclusion criteria (18 listed)
- Known or persistent mental disorders that require medication intervention and may interfere with the subject's participation in the study.
- Presence or suspicion of active viral, bacterial, fungal or parasitic infections;
- History of recurrent or chronic infections;
- History of epidemic meningococcal infection;
- History of splenectomy or asplenia;
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 |
|---|---|---|
| RG002C0106RG002C0106 is a siRNA drug targeting complement C3 to silence the related gene through the RNA interfering mechanism and inhibit the expression of C3 protein. | Drug | RG002C0106, placebo |
Primary outcome
Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug
Time frame: up to 169 days
Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 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. 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 RG002C0106 in people with Safety Issues, run by Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd. at 1 site in China.
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 18 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: finished, as of the sponsor's last update on 15 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug (time frame: up to 169 days). 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 Oct 2026.