ABCL575 for Healthy Subjects

Overseen By Clinical Trial Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: AbCellera Biologics Inc.

Must not be taking: Prescription drugs, OTC products

Disqualifiers: Pregnancy, Cardiovascular, Infections, others

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ABCL575 to evaluate its safety and tolerability. Participants will receive either a single dose of ABCL575 or a placebo (a harmless, inactive substance) through a small injection under the skin. The trial seeks healthy individuals who do not smoke or have major health issues. As an Early Phase 1 trial, this research aims to understand how ABCL575 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking any prescription drugs (except for hormonal contraceptives or hormone replacement therapy) 28 days before the study drug is given, and any over-the-counter products 7 days before.

Is there any evidence suggesting that ABCL575 is likely to be safe for humans?

Research has shown that ABCL575 was safe in early animal tests. Animals tolerated doses up to 100 mg/kg, the highest amount tested. Researchers administered the drug intravenously and subcutaneously. Importantly, these tests reported no negative effects. In this early-phase trial, researchers focus primarily on assessing the drug's safety and tolerability in humans. While earlier studies appear promising, this trial marks one of the initial steps in human testing of ABCL575, making it crucial to stay updated on new findings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

ABCL575 is unique because it is administered via a subcutaneous injection, which can be more convenient and less invasive than other forms of drug delivery like oral tablets or intravenous infusions. This treatment stands out because it offers a different mechanism of action, potentially providing benefits that current treatments for various conditions may not offer. Researchers are excited about ABCL575 because it could lead to faster or more effective results with fewer side effects, giving patients a better quality of life.

What evidence suggests that ABCL575 could be effective?

Research has shown that ABCL575 could be a promising treatment due to its mechanism of action. In early lab studies, ABCL575, an antibody, demonstrated strong potential by blocking pathways that cause inflammation. This suggests it might help reduce inflammation in conditions like atopic dermatitis, which leads to itchy, inflamed skin. Although these findings come from early lab studies, they indicate that ABCL575 might effectively treat inflammation-related issues. However, more research is needed to confirm its effectiveness in people. In this trial, healthy participants will receive a single dose of ABCL575 or a placebo to further investigate its potential effects. ^{2 4 6 7 8}

Who Is on the Research Team?

Eric Sicard

Principal Investigator

Altasciences Company Inc.

Are You a Good Fit for This Trial?

This trial is for healthy individuals who want to participate in a study testing the safety of a new medication called ABCL575. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and cannot have conditions that would exclude them from safely participating.

Inclusion Criteria

My weight is between 50 and 100 kg.

I agree not to donate sperm or eggs during and after the study until the end of study visit.

I have never smoked or have quit smoking for at least 6 months.

Exclusion Criteria

I have not used over-the-counter products in the last 7 days.

I have visible skin damage, like burns or dermatitis.

I have experienced fainting, heart palpitations, or unexplained dizziness.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ascending dose of ABCL575 or placebo administered by subcutaneous injection

1 day

Follow-up

Participants are monitored for safety and tolerability after receiving the dose

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABCL575

Trial Overview

The trial is examining the effects of different doses of ABCL575 compared to a placebo, which is just saltwater (Normal Saline 0.9%). It's designed to see how people tolerate the drug and what happens when they take it once at increasing dose levels.

How Is the Trial Designed?

Group I: ABCL575 Experimental Treatment 1 Intervention

Healthy participants will receive a single dose of ABCL575 administered by subcutaneous (SC) injection

Group II: Placebo Placebo Group 1 Intervention

Healthy participants will receive a single dose of placebo administered by subcutaneous (SC) injection

Who Is Running the Clinical Trial?

AbCellera Biologics Inc.

Lead Sponsor

Trials

6

Recruited

6,400+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07108894

A First-in-Human Phase 1 Single-Ascending Dose Study of ...

Study Overview. Brief Summary. This study aims to assess the safety and tolerability of ABCL575 in healthy participants following single ascending dose (SAD) ...

2.

investors.abcellera.com

investors.abcellera.com/news/news-releases/2025/AbCellera-Doses-First-Participants-in-a-Phase-1-Clinical-Trial-of-ABCL575/default.aspx

AbCellera Doses First Participants in a Phase 1 Clinical ...

The Phase 1 clinical trial of ABCL575 (NCT07108894) is a randomized, placebo-controlled, double-blind study to assess safety and tolerability in ...

3.

cdn.prod.website-files.com

cdn.prod.website-files.com/67e406136fae74782c76079b/681a7c37b38c906e5a53ebf3_POS035PRO%20-%20ABCL575%20-%20SID%202025_Final%20Web.pdf

POS035PRO - ABCL575 - SID 2025_Final Web

These preclinical data support the initiation of a Phase 1 study of ABCL575 in healthy volunteers. Concurrently, we are exploring next-generation agents to ...

4.

trial.medpath.com

trial.medpath.com/news/83d02160d62a998b/abcellera-s-abcl575-shows-promise-for-atopic-dermatitis-with-extended-half-life-in-preclinical-studies

AbCellera's ABCL575 Shows Promise for Atopic Dermatitis ...

AbCellera's novel anti-OX40L monoclonal antibody ABCL575 demonstrates potent inhibition of inflammatory pathways in preclinical studies for ...

5.

biospace.com

biospace.com/press-releases/abcellera-reports-q2-2025-business-results-first-participants-dosed-in-a-phase-1-clinical-trial-of-abcl635-for-vasomotor-symptoms

AbCellera Reports Q2 2025 Business Results & First ...

This is a randomized, placebo-controlled, double-blind study to assess safety and tolerability in healthy participants following subcutaneous ...

6.

abcellera.com

abcellera.com/pipeline/abcl575

ABCL575

A phase 1 clinical trial was initiated in Q3 of 2025 to assess safety and tolerability in healthy participants following subcutaneous doses of ...

7.

biospace.com

biospace.com/press-releases/abcellera-doses-first-participants-in-a-phase-1-clinical-trial-of-abcl575

AbCellera Doses First Participants in a Phase 1 Clinical ...

In preclinical studies, ABCL575 shows potent inhibition of T cell-mediated inflammatory pathways, favorable safety profile, and an in vivo half- ...

8.

msn.com

msn.com/en-us/health/other/abcellera-s-phase-1-study-of-abcl575-a-potential-game-changer/ar-AA1PiOLO

AbCellera's Phase 1 Study of ABCL575: A Potential Game- ...

' The study aims to evaluate the safety and tolerability of ABCL575, a new biological treatment, in healthy individuals through a single ascending dose approach ...