Hematologic DiseasesPhase 1NCT06797375
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of RLYB116 in Healthy Participants
A Phase 1 study testing RLYB116 for Injection in people with Hematologic Diseases and Autoimmune Diseases, run by Rallybio at 1 site in Australia.
Trial summary
This study will investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RLYB116 (with an improved impurity profile) following repeated administration of RLYB116 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hematologic Diseases, Autoimmune Diseases
- What is being tested?
- RLYB116 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteAustralia
- Study dates
- 14 Apr 2025to 23 Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female participants, 18 to 55 years of age.
- Able to provide written informed consent.
- Body mass index (BMI) of 18.0 to 32.0 kg/m2.
- 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:
- 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.
- Vaccination with Meningococcal Group B (Bexsero®) at least 14 days prior to receiving the first dose of RLYB116.
Who cannot join
- Participants that smoke more than 10 cigarettes per week
- Positive serology for HIV or active infection with hepatitis B virus or hepatitis C virus.
- Pregnant or nursing
- Donation or loss of greater than 400 mL of blood within 56 days of study enrollment
- History of severe hypersensitivity to any drug, including penicillin or ciprofloxacin, or to N. meningitidis or S. pneumoniae vaccines.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RLYB116 in Healthy Participants
This study will investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RLYB116 (with an improved impurity profile) following repeated administration of RLYB116 in healthy participants.
- Conditions
- Hematologic Diseases, Autoimmune Diseases
- Being tested
- RLYB116 for Injection
- Keywords
- complement-mediated diseases
- Medical subject headings
- Hematologic Diseases, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RLYB116 for InjectionDrug
RLYB116 is a small protein composed of an Affibody® Z-domain that binds with high affinity to C5, inhibiting terminal complement activation, and an albumin binding domain (ABD) that extends the effective plasma half-life of the protein by targeting serum albumin.
| Study group | Role | What they receive |
|---|---|---|
| RLYB116 Dose 1 | Experimental | RLYB116 for Injection Dose 1, weekly for 5 weeks Receives: Drug: RLYB116 for Injection |
| RLYB116 Dose 2 | Experimental | RLYB116 for Injection Dose 2, weekly for 5 weeks Receives: Drug: RLYB116 for Injection |
| Placebo for Injection | Placebo comparator | Sodium chloride injection, 0.9% saline (for both RLYB116 doses), weekly for 5 weeks Receives: Drug: RLYB116 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment related adverse events as defined by CTCAE 5.0.
Measured: From baseline to Day 1, 2, 3, 4, 5, 8, 9, 15, 16, 22, 23, 29, 30, 32, 33, 36, 43, 57, 71, 99
Secondary outcomes (3)
Inhibition of complement activation measured by free/total C5 concentrations and hemolytic activity
Measured: Day 1, 2, 8, 15, 29, 20, 32, 33, 43, 57, 71, 99
Anti-RLYB116 antibodies measured in serum
Measured: Day 1, 29, 99
Exposure to RLYB116 as measured in serum
Measured: Day 1, 2, 3, 4, 5, 8, 15, 29, 53, 57, 71, 99
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start14 Apr 2025
- Primary completion9 Feb 2026
- Study completion23 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic DiseasesStudies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rallybio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797375
- Sponsor's protocol ID
- IPC2401
- Status last verified
- Feb 2026
- First submitted
- 22 Jan 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RLYB116 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06797375
- Acronym / sponsor ID
- IPC2401
- Conditions
- Hematologic Diseases, Autoimmune Diseases
- Keywords
- complement-mediated diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- RallybioIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 9 Feb 2026 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 28 Jan 2025 (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.
This study will investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RLYB116 (with an improved impurity profile) following repeated administration of RLYB116 in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RLYB116 Dose 1 | Experimental | Drug: RLYB116 for InjectionRLYB116 for Injection Dose 1, weekly for 5 weeks |
| RLYB116 Dose 2 | Experimental | Drug: RLYB116 for InjectionRLYB116 for Injection Dose 2, weekly for 5 weeks |
| Placebo for Injection | Placebo comparator | Drug: RLYB116 for InjectionSodium chloride injection, 0.9% saline (for both RLYB116 doses), weekly for 5 weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female participants, 18 to 55 years of age.
- Able to provide written informed consent.
- Body mass index (BMI) of 18.0 to 32.0 kg/m2.
- 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:
Key exclusion criteria (5 listed)
- Participants that smoke more than 10 cigarettes per week
- Positive serology for HIV or active infection with hepatitis B virus or hepatitis C virus.
- Pregnant or nursing
- Donation or loss of greater than 400 mL of blood within 56 days of study enrollment
- History of severe hypersensitivity to any drug, including penicillin or ciprofloxacin, or to N. meningitidis or S. pneumoniae vaccines.
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 |
|---|---|---|
| RLYB116 for InjectionRLYB116 is a small protein composed of an Affibody® Z-domain that binds with high affinity to C5, inhibiting terminal complement activation, and an albumin binding domain (ABD) that extends the effective plasma half-life of the protein by targeting serum albumin. | Drug | Placebo for Injection, RLYB116 Dose 1, RLYB116 Dose 2 |
Primary outcome
Number of participants with treatment related adverse events as defined by CTCAE 5.0.
Time frame: From baseline to Day 1, 2, 3, 4, 5, 8, 9, 15, 16, 22, 23, 29, 30, 32, 33, 36, 43, 57, 71, 99
3 secondary outcomes
Inhibition of complement activation measured by free/total C5 concentrations and hemolytic activity
Time frame: Day 1, 2, 8, 15, 29, 20, 32, 33, 43, 57, 71, 99
Anti-RLYB116 antibodies measured in serum
Time frame: Day 1, 29, 99
Exposure to RLYB116 as measured in serum
Time frame: Day 1, 2, 3, 4, 5, 8, 15, 29, 53, 57, 71, 99
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RLYB116 for Injection in people with Hematologic Diseases and Autoimmune Diseases, run by Rallybio at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. 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: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment related adverse events as defined by CTCAE 5.0. (time frame: From baseline to Day 1, 2, 3, 4, 5, 8, 9, 15, 16, 22, 23, 29, 30, 32, 33, 36, 43, 57, 71, 99). 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 27 Feb 2026.