ADL-018 Delivery Methods in Healthy Subjects

Overseen By Dr Pallav Bharpoda, MBBS PGDCR

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Kashiv BioSciences, LLC

Must not be taking: MAOIs, CYP inhibitors, others

Disqualifiers: Diabetes, Psychosis, Asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how a new delivery method for the medication ADL-018 works in the body. Researchers are comparing two delivery methods: an autoinjector, which automatically injects the medicine, and a pre-filled syringe. The goal is to study the drug's movement through the body (pharmacokinetics) and ensure its safety and tolerability in healthy adults. Healthy non-smokers, not using certain medications or substances, and weighing between 50-90 kg may qualify. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the chance to be among the first to receive this new medication.

Will I have to stop taking my current medications?

The trial requires participants to stop taking any prescribed medications, herbal or dietary supplements, and over-the-counter medications within 14 days prior to the study medication administration. Additionally, certain foods and beverages must be avoided within specific timeframes before the study.

What prior data suggests that these delivery methods are safe for humans?

Research has shown that ADL-018, administered by autoinjector or syringe, appears safe for people. Previous studies found that injection site reactions, such as mild to moderate hives, discomfort, and redness, are common but manageable. These reactions are typical for many injections.

There is a small risk of more serious allergic reactions, like anaphylaxis, but these are rare. The treatment is currently in the early testing phase (Phase 1), so safety information remains limited. However, similar studies have reported no serious side effects, suggesting it is generally well-tolerated.

Overall, while more information is needed, early findings suggest that ADL-018 is relatively safe, with mild to moderate side effects being the most common issue. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they explore new delivery methods for administering ADL-018. The ADL-018 Autoinjector offers a more convenient and potentially more comfortable option compared to traditional injection methods. This autoinjector is designed to simplify the administration process, making it easier for individuals to use, which could improve adherence to treatment regimens. Additionally, the use of a pre-filled autoinjector may reduce the risk of dosing errors, offering a safer alternative to standard injection techniques.

What evidence suggests that this trial's delivery methods could be effective?

Studies have shown that ADL-018, a medication similar to Xolair, produced positive results in earlier clinical trials. These trials confirmed its effectiveness and safety. In this trial, participants will receive either the ADL-018 autoinjector or the injection form to evaluate the effectiveness of these delivery methods. Tests demonstrated that both the ADL-018 autoinjector and injection forms effectively deliver the medication. This suggests that ADL-018 is likely effective for the same conditions treated with Xolair. Additionally, the delivery systems, including the autoinjector, efficiently administer the drug. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

Healthy adults aged 18-65, weighing 50-90 kg with a BMI of 18.5 to 32, non-smokers for at least one year, and not using certain medications or substances. Women must test negative for pregnancy and use contraception. Excludes those with significant diseases, positive drug/alcohol tests, recent investigational drugs usage, allergies to latex or specific foods, immunological disorders like asthma, history of substance abuse within the past year.

Inclusion Criteria

I am a male or a non-pregnant, non-breastfeeding female with a recent negative pregnancy test.

Subject should have serum total IgE ≤ 100 IU/ml at the time of screening

Able to communicate effectively with study personnel

Exclusion Criteria

I do not have any health conditions that could worsen.

Positive drug screen, cotinine, or alcohol test during screening

Received any investigational drug/product within 30 days prior to the study medication administration

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of either the test product or reference product under fasting conditions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pharmacokinetic parameters and safety

126 days

Multiple visits for blood sampling and monitoring

What Are the Treatments Tested in This Trial?

Interventions

• ADL-018 Autoinjector
• ADL-018 Injection

Trial Overview The study is testing two ways of delivering ADL-018 Injection: via an autoinjector versus a pre-filled syringe. The goal is to compare how the body absorbs the medication from each method (pharmacokinetics) and evaluate their safety in healthy volunteers.

How Is the Trial Designed?

Group I: test product Experimental Treatment 1 Intervention

Test product (A): ADL-018 Injection 150 mg/mL solution in a single dose pre-filled autoinjector manufactured/supplied by Kashiv BioSciences LLC, USA.

Group II: reference product Active Control 1 Intervention

Reference Product (B): ADL-018 Injection 150mg/mL solution in a single dose pre-filled syringe manufactured/supplied by Kashiv Biosciences LLC, USA

Who Is Running the Clinical Trial?

Kashiv BioSciences, LLC

Lead Sponsor

Trials

4

Recruited

1,200+

Published Research Related to This Trial

The study found that auto-injector systems (A-INJ) effectively delivered both placebo and active injectates while maintaining blinding in randomized controlled trials, with no significant difference in delivery rates compared to conventional syringes.

Investigators reported no concerns about becoming unblinded when using the A-INJ, highlighting its potential to improve the integrity of clinical trials without the need for additional modifications to the placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blinding Is Seeing: A Single-Centre Study Into the Viability of Auto-Injectors for Blinded-Drug Administration in Randomised Controlled Trials. Aggarwal, V., Taubel, J., Lorch, U., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-1-urticaria-2025-09a87

ADL-018 Delivery Methods in Healthy Subjects The study found that auto-injector systems (A-INJ) effectively delivered both placebo and active injectates while maintaining blinding in randomized controlled ...

2. eisai.com eisai.com/news/2025/news202559.html

FDA Approves LEQEMBI® IQLIK™ (lecanemab-irmb) ... Data shows that transitioning to the weekly LEQEMBI IQLIK autoinjector after 18 months of the initiation dose (10 mg/kg IV every two weeks) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9127023/

Usability Study of PF-06410293, an Adalimumab Biosimilar ... All PFP users were able to successfully administer ADL-PF by PFP at each visit, and PFP injections of ADL-PF by patients or their caregivers ...

4. investors.biogen.com investors.biogen.com/news-releases/news-release-details/leqembir-iqliktmlecanemab-irmb-subcutaneous-autoinjector-named

LEQEMBI® IQLIK™(lecanemab-irmb) Subcutaneous ... Data shows that transitioning to the weekly LEQEMBI IQLIKTM autoinjector after 18 months of the initiation dose (10 mg/kg IV every two weeks) ...

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/kashiv-xolair-biosimilar/

Kashiv reports positive results from trial of Xolair biosimilar Kashiv has reported positive topline outcomes from the confirmatory trial of the proposed biosimilar to Novartis' Xolair, ADL-018.

6. xolairhcp.com xolairhcp.com/safety.html

Safety Profile - XOLAIR® (omalizumab) The types of injection site reactions included: urticaria, discomfort, erythema, pain, and rash. All injection site reactions were mild to moderate severity and ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05564611

PK, PD, Safety & Immunogenicity of ADL-018 Lyo in ... This will be a randomized, double blind, two-arm, single dose, parallel group, PK, PD and safety and immunogenicity study in healthy, adult, subjects.

8. xolair.com xolair.com/important-safety-information.html

XOLAIR® (omalizumab) Side Effects | Important Safety ... A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses.

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/103976s5245lbl.pdf

XOLAIR® (omalizumab) - accessdata.fda.gov Safety data ... A numerical decrease in weekly itch score was observed, and adverse reactions were similar to those reported in patients 18 years and older.