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Not yet recruitingNCT07873671Updated Oct 14, 2026

A Trial of RLX-2508-102 in Healthy Volunteers

An Early Phase 1 interventional study of RLX-2508 and RLX-2508 in Influenza, sponsored by Atridia Pty Ltd.. Not yet recruiting at 3 sites in Australia. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by Atridia Pty Ltd. (part of Jiangsu HengRui Medicine Co., Ltd.) · Early Phase 1, Interventional, and Prevention

Updated Oct 14, 2026Newly registeredGo to Updates ↓
Phase
Early Phase 1
Study type
Interventional
Enrollment
101
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Influenza

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03

In context

Influenza, Human

2,264 studies on the registry are indexed under Influenza, Human; 173 are open to participants now.

This study's planned enrollment of 101 is below the median of 240 across 1,894 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Atridia Pty Ltd. is the lead sponsor of 36 studies on the registry; 3 are open to participants now.

Browse Atridia Pty Ltd. studies →All Jiangsu HengRui Medicine Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Main inclusion criteria

  1. Male or female participant, including general adult populations, and participants of Japanese heritage.
  2. 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.
  3. 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.
  4. Men and WOCBP must agree to take highly effective contraceptive methods

Main exclusion Criteria

  1. History or evidence of clinically significant disorders.
  2. 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.
  3. 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.
  4. History of excessive smoking in the past 1 month prior to screening
  5. History of illicit or prescription drug abuse or addiction within 1 year of screening, or positive urine drug screen at baseline.
  6. 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

05

Study design

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

Study arms

  • Experimental
    Dose level 1 in healthy adultsCohort

    Single dose of RLX-2508 /placebo given subcutaneously

    Drug: RLX-2508

  • Experimental
    Cohort 2 -Dose level 2 in healthy adults

    Drug: RLX-2508

  • Experimental
    Cohort 3- Dose level 3 in healthy adults

    Repeated doses of RLX-2508 /placebo given subcutaneously

    Drug: RLX-2508

  • Experimental
    Cohort 4: Dose level 3 in healthy volunteers of Japanese heritage

    Single dose of RLX-2508 /placebo given subcutaneously

    Drug: RLX-2508

Interventions

  • DrugRLX-2508

    Single dose RLX-2508 /placebo given subcutaneously - Dose level 1

  • DrugRLX-2508

    Single dose RLX-2508 /placebo given subcutaneously - Dose level 2

  • DrugRLX-2508

    Repeated dose of RLX-2508 /placebo given subcutaneously - Dose level 3

  • DrugRLX-2508

    Single dose of RLX-2508 /placebo given subcutaneously - Dose level 3

06

What researchers measure

Primary outcomes

  1. Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events

    Number of participants with Adverse events and Serious adverse events

    Time frame: Day 360 & Day 450

Secondary outcomes

  1. PK Profile of RLX-2508 After a Single and multiple-Dose Administration • Pharmacokinetics - Cmax

    Maximum observed plasma concentration (Cmax)

    Time frame: Day 360 & Day 450

  2. 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)

    Time frame: Day 360 & Day 450

  3. PK Profile of RLX-2508 After a Single and multiple-Dose Administration • Pharmacokinetics - AUC0-inf

    Time to reach maximum observed plasma concentration (Tmax)

    Time frame: Day 360 & Day 450

  4. PK Profile of RLX-2508 After a Single and multiple-Dose Administration • Pharmacokinetics - t1/2

    Terminal elimination half-life (t1/2)

    Time frame: Day 360 & Day 450

  5. Immunogenicity profile of RLX-2508 after a Single and multiple dose administration:

    incidence of anti-drug antibodies (ADAs)

    Time frame: Day 360 & Day 450

07

Study locations

3 sites
  • Nucleus Network Sydney
    Sydney, New South Wales, Australia
  • Nucleus Network Brisbane
    Brisbane, Queensland, Australia
  • Nucleus Network Melbourne
    Melbourne, Victoria, Australia
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 14, 2026
Show all 1 update
  1. Oct 14, 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 ↗

09

Registry details

Key details

Study ID
NCT07873671
Lead sponsor
Atridia Pty Ltd.
Responsible party
Sponsor
First posted
Oct 14, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Jan 30, 2029 (estimated)
Completion
Jan 30, 2029 (estimated)
Last update
Oct 14, 2026

Study contacts

Kathy You
Contact
kathyyou@atridia.com
+61 02 9299 0433
Eimy Minowa
Contact
eimy.minowa@atridia.com
61 432223162

Oversight

FDA-regulated drug
No
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.

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