Healthy VolunteersPhase 1NCT06675565
A Study to Evaluate ALN-AGT01 RVR in Adult Healthy Volunteers
A Phase 1 study testing ALN-AGT01 RVR in people with Healthy Volunteers, run by Alnylam Pharmaceuticals at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and PK of single ascending doses of ALN-AGT01 RVR. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ALN-AGT01 RVR
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 5 Nov 2024to 8 Sep 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is an adult healthy volunteer
- Has a body mass index ≥18 kg/m^2 and ≤28 kg/m^2
Who cannot join
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > upper limit of normal (ULN)
- Has known human immunodeficiency virus infection; or known current or chronic hepatitis C virus or hepatitis B virus infection
- Has an estimated glomerular filtration rate (eGFR) of <90 mL/min/1.73m^2 at screening
- Note: other protocol defined inclusion / exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of ALN-AGT01 RVR in Adult Healthy Volunteers
The purpose of this study is to evaluate the safety, tolerability and PK of single ascending doses of ALN-AGT01 RVR.
- Conditions
- Healthy Volunteers
- Being tested
- ALN-AGT01 RVR, Placebo
- Keywords
- RNAi therapeutic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALN-AGT01 RVRDrug
ALN-AGT01 RVR will be administered subcutaneously (SC)
PlaceboDrug
Placebo will be administered SC
| Study group | Role | What they receive |
|---|---|---|
| ALN-AGT01 RVR | Experimental | Participants will be administered a single dose of ALN-AGT01 RVR. Receives: Drug: ALN-AGT01 RVR |
| Placebo | Placebo comparator | Participants will be administered a single dose of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events (AEs)
Measured: Up to 3 months
Secondary outcomes (4)
Area Under the Plasma Concentration-time Curve (AUC) of ALN-AGT01 RVR in Plasma
Measured: Predose and up to 3 days postdose
Maximum Observed Plasma Concentration (Cmax) of ALN-AGT01 RVR in Plasma
Measured: Predose and up to 3 days postdose
Time to Maximum Plasma Concentration (Tmax) of ALN-AGT01 RVR in Plasma
Measured: Predose and up to 3 days postdose
Concentrations of ALN-AGT01 RVR in Urine
Fraction of ALN-AGT01 RVR excreted in urine
Measured: Predose and up to 1 day postdone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start5 Nov 2024
- Primary completion8 Sep 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Alnylam PharmaceuticalsThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alnylam Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675565
- Sponsor's protocol ID
- ALN-AGT01 RVR-001
- Status last verified
- Sep 2025
- First submitted
- 29 Oct 2024
- Last updated
- 19 Sep 2025
- 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 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of ALN-AGT01 RVR in Adult Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06675565
- Acronym / sponsor ID
- ALN-AGT01 RVR-001
- Conditions
- Healthy Volunteers
- Keywords
- RNAi therapeutic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Alnylam PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 5 Nov 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.
The purpose of this study is to evaluate the safety, tolerability and PK of single ascending doses of ALN-AGT01 RVR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALN-AGT01 RVR | Experimental | Drug: ALN-AGT01 RVRParticipants will be administered a single dose of ALN-AGT01 RVR. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will be administered a single dose of placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Is an adult healthy volunteer
- Has a body mass index ≥18 kg/m^2 and ≤28 kg/m^2
Key exclusion criteria (4 listed)
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > upper limit of normal (ULN)
- Has known human immunodeficiency virus infection; or known current or chronic hepatitis C virus or hepatitis B virus infection
- Has an estimated glomerular filtration rate (eGFR) of <90 mL/min/1.73m^2 at screening
- Note: other protocol defined inclusion / exclusion criteria apply
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 |
|---|---|---|
| ALN-AGT01 RVRALN-AGT01 RVR will be administered subcutaneously (SC) | Drug | ALN-AGT01 RVR |
| PlaceboPlacebo will be administered SC | Drug | Placebo |
Primary outcome
Frequency of Adverse Events (AEs)
Time frame: Up to 3 months
4 secondary outcomes
Area Under the Plasma Concentration-time Curve (AUC) of ALN-AGT01 RVR in Plasma
Time frame: Predose and up to 3 days postdose
Maximum Observed Plasma Concentration (Cmax) of ALN-AGT01 RVR in Plasma
Time frame: Predose and up to 3 days postdose
Time to Maximum Plasma Concentration (Tmax) of ALN-AGT01 RVR in Plasma
Time frame: Predose and up to 3 days postdose
Concentrations of ALN-AGT01 RVR in Urine
Time frame: Predose and up to 1 day postdone
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 19 Sep 2025.
- 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.
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 ALN-AGT01 RVR in people with Healthy Volunteers, run by Alnylam Pharmaceuticals at 1 site in Canada.
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 2 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 19 Sep 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 Canada. 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?
Frequency of Adverse Events (AEs) (time frame: Up to 3 months). 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 19 Sep 2025.