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New Immune-Blocking drug tested in humans for first time

NCT ID NCT06797375

Disease control Sponsor: Rallybio Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested RLYB116, a small protein that blocks a part of the immune system called complement, in 16 healthy adults. The main goal was to see if it is safe and how the body handles it. Researchers also checked how well it stops complement activity. This is a first step toward possibly treating blood and autoimmune diseases.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RLYB116 (a small protein that blocks part of the immune system called complement)
What this could lead to
If successful, this could lead to a new treatment for blood and autoimmune diseases by controlling harmful immune activity.
What could go wrong
This is a very early, small study in healthy people, not patients. It only checks safety and drug levels, not whether it works for any disease. Side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

16 people

The number who actually took part.

Started

Apr 2025

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male and female participants, 18 to 55 years of age. 2. Able to provide written informed consent. 3. Body mass index (BMI) of 18.0 to 32.0 kg/m2. 4. Must have been vaccinated against N. meningitidis and S. pneumoniae with approved vaccine according to product label. All participants considered eligible for enrollment will be vaccinated or willing to receive vaccination according to the following: 1. Vaccination with Meningococcal Group A, C, W135, and Y conjugate vaccine (Menveo® or an acceptable alternative) + Pneumococcal Polysaccharide Vaccine (Pneumovax® 23 or an acceptable alternative) at least 28 days prior to receiving the first dose of RLYB116. 2. Vaccination with Meningococcal Group B (Bexsero®) at least 14 days prior to receiving the first dose of RLYB116. Exclusion Criteria: 1. Participants that smoke more than 10 cigarettes per week 2. Positive serology for HIV or active infection with hepatitis B virus or hepatitis C virus. 3. Pregnant or nursing 4. Donation or loss of greater than 400 mL of blood within 56 days of study enrollment 5. History of severe hypersensitivity to any drug, including penicillin or ciprofloxacin, or to N. meningitidis or S. pneumoniae vaccines.

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Conditions

The condition(s) this trial relates to.

autoimmune disease hematologic disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoimmune diseases Hematologic diseases

Contacts and locations

Locations

  • Nucleus Network Brisbane

    Brisbane, Queensland, 4006, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.