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

Trial Summary

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 data supports the effectiveness of the drug ADL-018?

The research on oral delivery of drugs using auto-injectors shows that this method can achieve high bioavailability (the amount of drug that enters the bloodstream) and rapid drug concentration in the body, which suggests that similar delivery methods for ADL-018 could be effective. Additionally, studies on auto-injectors indicate they can deliver drugs efficiently and maintain blinding in clinical trials, which supports their potential effectiveness in administering ADL-018. ^{1 2 3 4 5}

What safety data exists for ADL-018 and its delivery methods?

A study on a similar product, PF-06410293 (an adalimumab biosimilar), showed that it was well tolerated in healthy subjects when administered using a prefilled pen or syringe, with similar adverse events and injection-site reactions between the two methods. ^{2 4 6 7 8}

How does the ADL-018 drug differ from other treatments?

The ADL-018 drug is unique because it uses an autoinjector system, which helps maintain blinding in clinical trials by making it difficult to distinguish between the active drug and placebo. This method improves the administration process without needing to alter the appearance of the injectate, unlike traditional methods that may require additives. ^{2 3 4 5 9}

What is the purpose of this trial?

The Goal of these study is to assess the comparative pharmacokinetics of Test Product (A): ADL-018 Injection 150 mg/mL solution in a single dose pre-filled autoinjector, manufactured by Kashiv Biosciences LLC, USA with Reference Product (B): ADL-018 Injection 150mg/mL solution in a single dose pre-filled syringe manufactured by Kashiv Biosciences LLC, USA in healthy, adult human subjects. and also to assess safety and tolerability of investigational product.

Eligibility Criteria

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

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

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

Able to communicate effectively with study personnel

Exclusion Criteria

I don't have any major diseases or abnormal findings from recent health checks.

I do not have any health conditions that could worsen.

Positive drug screen, cotinine, or alcohol test during screening

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Oral delivery of systemic monoclonal antibodies, peptides and small molecules using gastric auto-injectors. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Patient acceptance of a novel electronic auto-injector device to administer recombinant human growth hormone: results from an open-label, user survey of everyday use. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Advances in Large Volume Subcutaneous Injections: A Pilot Tolerability Study of an Innovative Needle-Free Injection Platform. [2023]

4. United States 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Passive drug diffusion via standardized skin mini-erosion; methodological aspects and clinical findings with new device. [2019]

6. United Arab Emirates pubmed.ncbi.nlm.nih.gov

A Systematic Literature Review of Injection Site Pain Perception in Adult Patients Treated with Citrate-Free and Citrate-Containing Biologic Agents. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Safety, tolerability, and pharmacokinetics of SPL7013 gel (VivaGel): a dose ranging, phase I study. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Randomized, Open-Label, Single-Dose, Parallel-Group Pharmacokinetic Study of PF-06410293 (adalimumab-afzb), an Adalimumab Biosimilar, by Subcutaneous Dosing Using a Prefilled Syringe or a Prefilled Pen in Healthy Subjects. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Current status and future prospects of needle-free liquid jet injectors. [2022]