InfluenzaEarly Phase 1NCT07873671
A Trial of RLX-2508-102 in Healthy Volunteers
A Early Phase 1 study testing RLX-2508 in people with Influenza, run by Atridia Pty Ltd. at 3 sites in Australia.
Trial summary
The purpose of this study is to assess safety, PK and immunogenicity profile of a single dose and multiple dose of RLX-2508 in healthy participants across different ethnic backgrounds. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- RLX-2508
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 3 sitesAustralia
- Study dates
- 15 Nov 2026to 30 Jan 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Main inclusion criteria
- Male or female participant, including general adult populations, and participants of Japanese heritage.
- Capable to give consent and have ability to understand the trial procedures and possible adverse events, volunteer to participate in the trial, and provide written informed consent, be able to comply with all the requirements, and able to complete the study.
- Women with body weight ≥ 45.0 kg, men with body weight ≥ 50.0 kg, body mass index (BMI) between 19.0 and 32.0 kg/m2 (inclusive) at screening and baseline, except for Japanese participants, for whom a BMI range of 18.0 to 28.0 kg/m² (inclusive) will apply.
- Men and WOCBP must agree to take highly effective contraceptive methods
Main exclusion Criteria
- History or evidence of clinically significant disorders.
- Individuals with a history of drug allergies, specific allergies, or known history or suspected of being allergic to the study drug or same class drug or any component of it.
- Previous participation in another clinical trial (including medical devices or another investigational drug) within 3 months or 5 half-lives, whichever is longer prior to screening.
- History of excessive smoking in the past 1 month prior to screening
- History of illicit or prescription drug abuse or addiction within 1 year of screening, or positive urine drug screen at baseline.
- Any other circumstances (e.g., not suitable for venous access) or laboratory abnormality that, in the investigator's judgment, may increase the risk to the participant, or be associated with the participant's participation in and completion of the study or could preclude the evaluation of the participant's response.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites
Nucleus Network Brisbane
Brisbane, Queensland
Nucleus Network Brisbane, 1800 243 733, brisbane@nucleusnetwork.com
Nucleus Network Melbourne
Melbourne, Victoria
melbourne@nucleusnetwork.com, 1800 243 733, melbourne@nucleusnetwork.com
Nucleus Network Sydney
Sydney, New South Wales
Nucleus Network Sydney, 1800 243 733, sydney@nucleusnetwork.com.au
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-Controlled, Single and Multiple-Dose and Extended Safety Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of RLX-2508 in Healthy Adult Participants
The purpose of this study is to assess safety, PK and immunogenicity profile of a single dose and multiple dose of RLX-2508 in healthy participants across different ethnic backgrounds.
- Conditions
- Influenza
- Being tested
- RLX-2508
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RLX-2508Drug
Single dose RLX-2508 /placebo given subcutaneously - Dose level 1
RLX-2508Drug
Single dose RLX-2508 /placebo given subcutaneously - Dose level 2
RLX-2508Drug
Repeated dose of RLX-2508 /placebo given subcutaneously - Dose level 3
RLX-2508Drug
Single dose of RLX-2508 /placebo given subcutaneously - Dose level 3
| Study group | Role | What they receive |
|---|---|---|
| Dose level 1 in healthy adultsCohort | Experimental | Single dose of RLX-2508 /placebo given subcutaneously Receives: Drug: RLX-2508 |
| Cohort 2 -Dose level 2 in healthy adults | Experimental | Not described Receives: Drug: RLX-2508 |
| Cohort 3- Dose level 3 in healthy adults | Experimental | Repeated doses of RLX-2508 /placebo given subcutaneously Receives: Drug: RLX-2508 |
| Cohort 4: Dose level 3 in healthy volunteers of Japanese heritage | Experimental | Single dose of RLX-2508 /placebo given subcutaneously Receives: Drug: RLX-2508 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events
Number of participants with Adverse events and Serious adverse events
Measured: Day 360 & Day 450
Secondary outcomes (5)
PK Profile of RLX-2508 After a Single and multiple-Dose Administration • Pharmacokinetics - Cmax
Maximum observed plasma concentration (Cmax)
Measured: Day 360 & Day 450
PK Profile of RLX-2508 After a Single and multiple-Dose Administration • Pharmacokinetics - AUC0-inf
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
Measured: Day 360 & Day 450
PK Profile of RLX-2508 After a Single and multiple-Dose Administration • Pharmacokinetics - AUC0-inf
Time to reach maximum observed plasma concentration (Tmax)
Measured: Day 360 & Day 450
PK Profile of RLX-2508 After a Single and multiple-Dose Administration • Pharmacokinetics - t1/2
Terminal elimination half-life (t1/2)
Measured: Day 360 & Day 450
Immunogenicity profile of RLX-2508 after a Single and multiple dose administration:
incidence of anti-drug antibodies (ADAs)
Measured: Day 360 & Day 450
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start15 Nov 2026 (estimated)
- Primary completion30 Jan 2029 (estimated)
- Study completion30 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RLX-2508 or matching placebo given subcutaneously
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 101 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atridia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873671
- Sponsor's protocol ID
- RLX-2508-102
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-Controlled, Single and Multiple-Dose and Extended Safety Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of RLX-2508 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07873671
- Acronym / sponsor ID
- RLX-2508-102
- Conditions
- Influenza
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 101 participants (estimated)
- Lead sponsor
- Atridia Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 30 Jan 2029 (estimated)
- Study completion
- 30 Jan 2029 (estimated)
- First posted
- 14 Oct 2026 (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 assess safety, PK and immunogenicity profile of a single dose and multiple dose of RLX-2508 in healthy participants across different ethnic backgrounds.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- RLX-2508 or matching placebo given subcutaneously
| Arm | Type | Receives |
|---|---|---|
| Dose level 1 in healthy adultsCohort | Experimental | Drug: RLX-2508Single dose of RLX-2508 /placebo given subcutaneously |
| Cohort 2 -Dose level 2 in healthy adults | Experimental | Drug: RLX-2508 |
| Cohort 3- Dose level 3 in healthy adults | Experimental | Drug: RLX-2508Repeated doses of RLX-2508 /placebo given subcutaneously |
| Cohort 4: Dose level 3 in healthy volunteers of Japanese heritage | Experimental | Drug: RLX-2508Single dose of RLX-2508 /placebo given subcutaneously |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| RLX-2508Single dose RLX-2508 /placebo given subcutaneously - Dose level 1 | Drug | Dose level 1 in healthy adultsCohort |
| RLX-2508Single dose RLX-2508 /placebo given subcutaneously - Dose level 2 | Drug | Cohort 2 -Dose level 2 in healthy adults |
| RLX-2508Repeated dose of RLX-2508 /placebo given subcutaneously - Dose level 3 | Drug | Cohort 3- Dose level 3 in healthy adults |
| RLX-2508Single dose of RLX-2508 /placebo given subcutaneously - Dose level 3 | Drug | Cohort 4: Dose level 3 in healthy volunteers of Japanese heritage |
Primary outcome
Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events
Time frame: Day 360 & Day 450
Number of participants with Adverse events and Serious adverse events
5 secondary outcomes
PK Profile of RLX-2508 After a Single and multiple-Dose Administration • Pharmacokinetics - Cmax
Time frame: Day 360 & Day 450
PK Profile of RLX-2508 After a Single and multiple-Dose Administration • Pharmacokinetics - AUC0-inf
Time frame: Day 360 & Day 450
PK Profile of RLX-2508 After a Single and multiple-Dose Administration • Pharmacokinetics - AUC0-inf
Time frame: Day 360 & Day 450
PK Profile of RLX-2508 After a Single and multiple-Dose Administration • Pharmacokinetics - t1/2
Time frame: Day 360 & Day 450
Immunogenicity profile of RLX-2508 after a Single and multiple dose administration:
Time frame: Day 360 & Day 450
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing RLX-2508 in people with Influenza, run by Atridia Pty Ltd. at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 14 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 3 sites in Australia. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathy You (+61 02 9299 0433, kathyyou@atridia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events (time frame: Day 360 & Day 450). 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 14 Oct 2026.