Healthy VolunteersPhase 1NCT05429073
A Study of RGLS8429 in Healthy Volunteers
A Phase 1 study testing RGLS8429 in people with Healthy Volunteers, run by Regulus Therapeutics Inc. at 1 site in United States.
Trial summary
Primary Objective To assess the safety and tolerability of single ascending doses of RGLS8429 Secondary Objectives To identify dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) of a single SC dose of RGLS8429 To characterize the pharmacokinetic (PK) properties of RGLS8429 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- RGLS8429
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2022to 8 Sep 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female, 18 to 55 years of age
- Body mass index (BMI) 18 to 35 kg/m2
- Medically healthy, with no clinically significant medical history in the opinion of the Investigator
- Estimated glomerular filtration rate (eGFR) ≥ 90 mL/min/1.73 m2
- Must understand and consent to the study procedures explained in the informed consent form (ICF) and be willing and able to comply with the protocol
Who cannot join
- Subject is mentally incapacitated or has significant emotional problems
- Any medical condition or social circumstance that, in the opinion of the Investigator, may make the subject unlikely to complete the study or comply with study procedures and requirements, or may pose a risk to the subject's safety
- History or presence of alcoholism or drug abuse within the past 2 years prior to Screening
- Participation in another clinical trial and/or exposure to any investigational drug or approved therapy for investigational use within 28 days or 5 half-lives of the investigational drug's dosing, whichever is longer, prior to dosing. The 28-day and 5-half-life windows will be calculated from the date of the last dosing in the previous study to Day 1 of the current study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-Blind, Placebo-Controlled, Single Ascending Dose Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of RGLS8429
Primary Objective
- To assess the safety and tolerability of single ascending doses of RGLS8429
Secondary Objectives
- To identify dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) of a single SC dose of RGLS8429
- To characterize the pharmacokinetic (PK) properties of RGLS8429
Read the detailed description
In this randomized, double-blind, placebo-controlled Phase 1 study, a single ascending dose of RGLS8429 or placebo will be administered via subcutaneous (SC) injection to healthy volunteers to evaluate the safety, tolerability, and PK of RGLS8429.
- Conditions
- Healthy Volunteers
- Being tested
- RGLS8429, Placebo volume-matching RGLS8429 dose
- Keywords
- RGLS8429, Autosomal Dominant Polycystic Kidney Disease, ADPKD
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGLS8429Drug
solution for subcutaneous injection
Placebo volume-matching RGLS8429 doseDrug
solution for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| RGLS8429, first dose level | Experimental | Eligible participants will receive subcutaneous injection of the first dose level RGLS8429 or placebo Receives: Drug: RGLS8429; Drug: Placebo volume-matching RGLS8429 dose |
| RGLS8429, second dose level | Experimental | Eligible participants will receive subcutaneous injection of the second dose level RGLS8429 or placebo Receives: Drug: RGLS8429; Drug: Placebo volume-matching RGLS8429 dose |
| RGLS8429, third dose level | Experimental | Eligible participants will receive subcutaneous injection of the third dose level RGLS8429 or placebo Receives: Drug: RGLS8429; Drug: Placebo volume-matching RGLS8429 dose |
| RGLS8429, fourth dose level | Experimental | Eligible participants will receive subcutaneous injection of the fourth dose level RGLS8429 or placebo Receives: Drug: RGLS8429; Drug: Placebo volume-matching RGLS8429 dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Incidence and severity of adverse events after administration of RGLS8429
Measured: Baseline to Day 29
Secondary outcomes (5)
Incidence of DLT and Determination of MTD
Identify dose limiting toxicity and the maximum tolerated dose after RGLS8429 administration
Measured: Baseline to Day 29
Plasma Half-life (T1/2) of RGLS8429
Measure plasma elimination half-life after RGLS8429 administration
Measured: Baseline to Day 15
Plasma Clearance of RGLS8429
Measure plasma clearance after RGLS8429 administration
Measured: Baseline to Day 15
Area Under the Plasma Concentration vs Time Curve (AUC) of RGLS8429
Measure area under the plasma concentration vs time curve after RGLS8429 administration
Measured: Baseline to Day 15
Amount of RGLS8429 Excreted in Urine
Measure the amount of RGLS8429 excreted in urine after RGLS8429 administration
Measured: Baseline to 24-hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start10 Jun 2022
- Primary completion8 Sep 2022
- Study completion8 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regulus Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rekha Garg, MD, Study director, Regulus Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429073
- Sponsor's protocol ID
- RGLS8429-01
- Status last verified
- Aug 2025
- First submitted
- 26 May 2022
- Last updated
- 27 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Placebo-Controlled, Single Ascending Dose Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of RGLS8429
- ClinicalTrials.gov ID
- NCT05429073
- Acronym / sponsor ID
- RGLS8429-01
- Conditions
- Healthy Volunteers
- Keywords
- RGLS8429, Autosomal Dominant Polycystic Kidney Disease, ADPKD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Regulus Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 8 Sep 2022 (actual)
- Study completion
- 8 Sep 2022 (actual)
- First posted
- 23 Jun 2022 (actual)
- Results
- Posted 27 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective
- To assess the safety and tolerability of single ascending doses of RGLS8429
Secondary Objectives
- To identify dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) of a single SC dose of RGLS8429
- To characterize the pharmacokinetic (PK) properties of RGLS8429
Detailed description
In this randomized, double-blind, placebo-controlled Phase 1 study, a single ascending dose of RGLS8429 or placebo will be administered via subcutaneous (SC) injection to healthy volunteers to evaluate the safety, tolerability, and PK of RGLS8429.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RGLS8429, first dose level | Experimental | Drug: RGLS8429, Drug: Placebo volume-matching RGLS8429 doseEligible participants will receive subcutaneous injection of the first dose level RGLS8429 or placebo |
| RGLS8429, second dose level | Experimental | Drug: RGLS8429, Drug: Placebo volume-matching RGLS8429 doseEligible participants will receive subcutaneous injection of the second dose level RGLS8429 or placebo |
| RGLS8429, third dose level | Experimental | Drug: RGLS8429, Drug: Placebo volume-matching RGLS8429 doseEligible participants will receive subcutaneous injection of the third dose level RGLS8429 or placebo |
| RGLS8429, fourth dose level | Experimental | Drug: RGLS8429, Drug: Placebo volume-matching RGLS8429 doseEligible participants will receive subcutaneous injection of the fourth dose level RGLS8429 or placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female, 18 to 55 years of age
- Body mass index (BMI) 18 to 35 kg/m2
- Medically healthy, with no clinically significant medical history in the opinion of the Investigator
- Estimated glomerular filtration rate (eGFR) ≥ 90 mL/min/1.73 m2
- Must understand and consent to the study procedures explained in the informed consent form (ICF) and be willing and able to comply with the protocol
Key exclusion criteria (4 listed)
- Subject is mentally incapacitated or has significant emotional problems
- Any medical condition or social circumstance that, in the opinion of the Investigator, may make the subject unlikely to complete the study or comply with study procedures and requirements, or may pose a risk to the subject's safety
- History or presence of alcoholism or drug abuse within the past 2 years prior to Screening
- Participation in another clinical trial and/or exposure to any investigational drug or approved therapy for investigational use within 28 days or 5 half-lives of the investigational drug's dosing, whichever is longer, prior to dosing. The 28-day and 5-half-life windows will be calculated from the date of the last dosing in the previous study to Day 1 of the current study.
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 |
|---|---|---|
| RGLS8429solution for subcutaneous injection | Drug | RGLS8429, first dose level, RGLS8429, fourth dose level, RGLS8429, second dose level, RGLS8429, third dose level |
| Placebo volume-matching RGLS8429 dosesolution for subcutaneous injection | Drug | RGLS8429, first dose level, RGLS8429, fourth dose level, RGLS8429, second dose level, RGLS8429, third dose level |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: Baseline to Day 29
Incidence and severity of adverse events after administration of RGLS8429
5 secondary outcomes
Incidence of DLT and Determination of MTD
Time frame: Baseline to Day 29
Plasma Half-life (T1/2) of RGLS8429
Time frame: Baseline to Day 15
Plasma Clearance of RGLS8429
Time frame: Baseline to Day 15
Area Under the Plasma Concentration vs Time Curve (AUC) of RGLS8429
Time frame: Baseline to Day 15
Amount of RGLS8429 Excreted in Urine
Time frame: Baseline to 24-hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Rekha Garg, MD study director
Regulus Therapeutics
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 RGLS8429 in people with Healthy Volunteers, run by Regulus Therapeutics Inc. at 1 site in United States.
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 5 inclusion and 4 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 27 Aug 2025. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 27 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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) (time frame: Baseline to Day 29). 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 27 Aug 2025.