RecruitingPhase 1

A Phase I Clinical Trial to Assess the Safety and Immunogenicity of DX-104

Australia30 participantsStarted 2026-03-20

Plain-language summary

A randomized, double-blinded, positive-controlled clinical trial will be conducted to observe the safety and immunogenicity of DX-104 in adults 18 to 50 years of age.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy male or female participants aged 18 to 50 years (inclusive) at the time of screening, who can provide valid legal identification.
. Willing and able to give written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
. Willing and able to comply with all study procedures and available for the entire duration of the study follow-up.
. Participants must have a Body Mass Index (BMI) between ≥18.0 and ≤32.0 kg/m2 at screening.
. For female participants at least 1 of the following conditions must apply:
. Females should not be currently breastfeeding, and should not breastfeed for the duration of the study.
. Male participants are able to participate if they:

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To assess the overall safety of DX-104

Timeframe: Through study completion, an average of 1 year.

Trial details

NCT IDNCT07395739

SponsorShanghai Yuguan Biotech Co., Ltd.（Delonix Bioworks)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-05-01

Contact for this trial

Project Manager

（+86）021-50360201 clic@delonixbio.com

View on ClinicalTrials.gov More Neisseria Meningitidis Serogroup B trials