A Phase 1 interventional study of RG002C0106 and 0.9% sodium chloride injection in Safety Issues, sponsored by Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.. Not yet recruiting at 1 site in Austria. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd. · Phase 1, Interventional, and Treatment
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.
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.
Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Randomly enrolled subjects receiving the investigational drug will receive subcutaneous injection for administration
Drug: RG002C0106
Randomly enrolled subjects receiving 0.9% sodium chloride injection will receive subcutaneous injection for administration
Drug: 0.9% sodium chloride injection
At Day 1, each participants will be given one dose of RG002C0106 Injection.
Also known as: 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 0.9% sodium chloride injection.
Also known as: placebo
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
Time frame: within 169 days after the administration
maximum drug concentration (Cmax)
Blood samples are collected to detect drug consentration for maximum drug concentration (Cmax)
Time frame: 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
Time frame: 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.
Time frame: 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)
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
Blood samples are collected to detect drug consentration for 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)
Blood samples are collected to detect drug consentration for elimination half-life (t1/2)
Time frame: at designed time points within three days after the administration
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.