ClinicalTrials.gg
Not yet recruitingNCT07902245Updated Oct 28, 2026

Phase 1 Study to Evaluate RG002C0106 Injection in Healthy Participants

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

Updated Oct 28, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Safety Issues

Keywords

  • Safety
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  1. 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 form (ICF);
  2. Healthy male or female participants aged 18-55 years (inclusive);
  3. At screening, judged by the investigator to be in good health based on medical history, physical examination, vital signs, 12-lead , and clinical laboratory tests;
  4. Male participants with body weights ≥ 50 kg, female participants with body weights ≥ 45 kg, and body mass indexes (BMIs, inclusive): 18-30 kg/m2;
  5. Female participants of must have a negative pregnancy test at screening and Day -1;
  6. Female participants of childbearing potential or male participants with female partners of childbearing potential must agree to use a highly effective 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.
  7. 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.

Exclusion criteria

Exclusion Criteria:

  1. 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 drug or its , or those with current allergic conditions (assessed through interrogation), as judged by the investigator;
  2. 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;
  3. Special dietary requirements and cannot follow the study standardized meals (e.g., lactose intolerance, dysphagia);
  4. 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;
  5. Participants with confirmed or suspected presence of active viral, bacterial, fungal, or parasitic infections within 1 month before the screening;
  6. Participants with a history of recurrent or chronic infections;
Terms in these criteria, in plain language(6)

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.

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.

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.

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.

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.

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.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    RG002C0106 injection

    Randomly enrolled subjects receiving the investigational drug will receive subcutaneous injection for administration

    Drug: RG002C0106

  • Placebo comparator
    0.9% sodium chloride injection

    Randomly enrolled subjects receiving 0.9% sodium chloride injection will receive subcutaneous injection for administration

    Drug: 0.9% sodium chloride injection

Interventions

  • DrugRG002C0106

    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.

  • Drug0.9% sodium chloride injection

    At Day 1, each participants will be given one dose of 0.9% sodium chloride injection.

    Also known as: placebo

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

07

Study locations

1 site
  • Novatrials
    City of Lake Macquarie, New South Wales 2290, Austria
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07902245
Lead sponsor
Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.
Responsible party
Sponsor
First posted
Oct 28, 2026
Start date
Dec 10, 2026 (estimated)
Primary completion
Mar 31, 2028 (estimated)
Completion
Mar 31, 2028 (estimated)
Last update
Oct 28, 2026

Study contacts

Zhu Lingling Zhu
Contact
llzhu@rigerna.com
8610-63729218
Jennifer Martin
principal investigator · Novatrials

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion