Starting soon
Early Phase 1
A Trial of RLX-2508-102 in Healthy Volunteers
Condition(s) studied
Influenza
Investigational drug(s) / intervention(s)
RLX-2508RLX-2508RLX-2508RLX-2508
RLX-2508: Single dose RLX-2508 /placebo given subcutaneously - Dose level 1
RLX-2508: Single dose RLX-2508 /placebo given subcutaneously - Dose level 2
RLX-2508: Repeated dose of RLX-2508 /placebo given subcutaneously - Dose level 3
RLX-2508: Single dose of RLX-2508 /placebo given subcutaneously - Dose level 3
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.
Eligibility
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
Primary outcome measure(s)
- Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events — Day 360 & Day 450
Number of participants with Adverse events and Serious adverse events
Trial sites (3)
| Facility | City | Region | Status |
| Nucleus Network Sydney |
Sydney |
New South Wales |
|
| Nucleus Network Brisbane |
Brisbane |
Queensland |
|
| Nucleus Network Melbourne |
Melbourne |
Victoria |
|
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