A Comparative Pharmacokinetic Study of ADL-018 Autoinjector Compared to A Pre-filled Syringe in Healthy Subjects.

NCT06929052 | Completed Phase 1 FDA Drug

• 1 other identifier: ADL-018 Autoinjector
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Adult Subjects

Keywords

Xolair

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic parameter

  Cmax

  Baseline to day 126

• Pharmacokinetic parameter

  AUC0-t

  Baseline to day 126

• Pharmacokinetic parameter

  AUC0-inf

  baseline to day 126

Study Arms (2)

test product

EXPERIMENTAL

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

Device: ADL-018 Autoinjector

reference product

ACTIVE COMPARATOR

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

Drug: ADL-018 Injection

Interventions

ADL-018 Autoinjector DEVICE

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

test product

ADL-018 Injection DRUG

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

reference product

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 65 years of age, inclusive, at the time of dosing.
• Subject should be having serum total IgE ≤ 100 IU/ml at the time of screening
• Gender: Male and/or non-pregnant, non-lactating female. Female of childbearing potential must have a negative serum pregnancy test performed within 28 days prior to dosing day.
• Male subjects and/or female subject's partner must agree to use acceptable form of contraception which includes vasectomy, or use condoms, or spermicide in addition to female contraception for additional protection against conception from screening until 156 days after administration of the study medication.
• For female of childbearing potential, must agree to use acceptable forms of contraception from screening until 156 days after administration of the
• Investigational Product include the following:
• Non hormonal intrauterine device in place, or Barrier methods containing or used in conjunction with a spermicidal agent, or Surgical sterilization or Practicing sexual abstinence.
• Female will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
• Postmenopausal with spontaneous amenorrhea for at least one year, or Spontaneous amenorrhea for more than 6 months and less than one year with Serum Follicular Stimulating Hormone (FSH) level \> 40 IU/L, or Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or Total hysterectomy and an absence of bleeding for at least 3 months.
• BMI: 18.5 to 32.0 kg/m2, both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g., 32.04 rounds down to 32.0, while 18.49 rounds up to 18.5).
• Volunteers having body weight ≥50.0 kg or ≤ 90.0 kg.
• Able to communicate effectively with study personnel.
• Willing to provide written informed consent to participate in the study.
• Non-smokers and non-tobacco users (i.e., having no past history of smoking and tobacco consuming for at least one year prior to study).
• All volunteers must be judged by the principal and /or sub investigator principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the study medication administration which will include:

You may not qualify if:

• History of allergic responses to study drug or other related drugs, or any of its formulation ingredients.
• History of allergic reactions or sensitivity to latex or latex derived products.
• Have significant diseases or clinically significant abnormal findings during screening \[medical history, comprehensive physical examination, vital signs, laboratory evaluations and ECG\].
• Any disease or condition like diabetes, psychosis or others, which might compromise the hemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
• History of helminthic or parasitic infection.
• History of immunological disorders or presence of bronchial asthma.
• Use of any hormone replacement therapy within 3 months prior to the study medication administration.
• Use of any depot injection or implant of any drug within 3 months prior to the study medication administration.
• Use of CYP enzyme inhibitors or inducers or St. John's Wort within 30 days prior to the study medication administration (see https://druginteractions. medicine.iu.edu/MainTable.aspx).
• Reports a history of drug or alcohol addiction or abuse within the past 1 year.
• History or evidence of drug dependence.
• History of difficulty with donating blood or difficulty in accessibility of veins.
• A positive hepatitis screen (hepatitis B surface antigen, hepatitis C antibody).
• A positive test result for HIV antibody.
• Demonstrates a positive drug screen, cotinine, or alcohol test during screening

Sponsors & Collaborators

• Kashiv BioSciences, LLC: lead

Study Sites (1)

Cliantha Research

Mississauga, ON L4W 1A4, Canada

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: April 15, 2025
• Study Start: January 29, 2025
• Primary Completion: August 15, 2025
• Study Completion: August 30, 2025
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

CA (1)