To Compare the PK, PD, Safety & Immunogenicity of ADL-018 in Healthy Subjects

NCT05413161 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: OMA/2019/1692CTRI/2022/06/043399
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 2

Brief Summary

This will be a randomized, double blind, three-arm, single dose, parallel group, PK, PD and safety and immunogenicity study in healthy, adult, subjects. Total 306 healthy, adult, eligible human subjects (102 in each treatment arm) will be enrolled in the study with their consent. Required \*standby subjects will also be enrolled to ensure that 306 subjects are dosed in the study. The study will be conducted in cohorts; all the study procedures will be identical as mentioned in the protocol for all the cohorts.

Conditions

Healthy

Keywords

ADL-018, XOLAIR

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetic Outcome Measures [Cmax]

  Maximum serum concentration (Cmax) of ADL-018, EU approved Xolair, and US-licensed Xolair in healthy subjects (ADL-018 to EU approved Xolair, ADL-018 to US licensed Xolair, and EU-approved Xolair to US licensed Xolair)

  Upto Day 126

• Pharmacokinetic Outcome Measures [AUC0-last]

  Area Under the concentration-time Curve from time zero to the last quantifiable concentration (AUC0-last) of ADL-018, EU approved Xolair, and US-licensed Xolair in healthy subjects (ADL-018 to EU approved Xolair, ADL-018 to US licensed Xolair, and EU-approved Xolair to US licensed Xolair)

  Upto Day 126

• Pharmacokinetic Outcome Measures [AUC0-inf]

  Area Under the concentration-time Curve from time zero to infinity (AUC0-inf) of ADL-018, EU approved Xolair, and US-licensed Xolair in healthy subjects (ADL-018 to EU approved Xolair, ADL-018 to US licensed Xolair, and EU-approved Xolair to US licensed Xolair)

  Upto Day 126

• Incidence of Adverse events of Special Interest [Safety]

  Adverse events of Special Interest (AESI) of ADL-018, EU approved Xolair, and US-licensed Xolair in healthy subjects (e.g., Allergic reactions type 1/anaphylaxis, injection site reactions, serum sickness/serum sickness-like reactions, and parasitic infections)

  Upto Day 126

Secondary Outcomes (7)

• Pharmacokinetic Outcome Measures [Tmax]

  Upto Day 126

• Pharmacokinetic Outcome Measures [t1/2]

  Upto Day 126

• Pharmacokinetic Outcome Measures [Apparent total body clearance (CL/F)]

  Upto day 126

• Pharmacokinetic Outcome Measures [λz]

  Upto day 126

• Pharmacokinetic Outcome Measures [Vz/F]

  Upto day 126

Study Arms (3)

ADL-018

EXPERIMENTAL

150 mg/mL, Solution for injection in PFS

Biological: ADL-018

US-Licensed XOLAIR

ACTIVE COMPARATOR

150 mg/mL, Solution for injection in PFS

Biological: US-licensed XOLAIR

EU-Approved XOLAIR

ACTIVE COMPARATOR

150 mg/mL, Solution for injection in PFS

Biological: EU-Approved XOLAIR

Interventions

ADL-018 BIOLOGICAL

150 mg/mL, Solution for injection in PFS

ADL-018

US-licensed XOLAIR BIOLOGICAL

150 mg/mL, Solution for injection in PFS

US-Licensed XOLAIR

EU-Approved XOLAIR BIOLOGICAL

150 mg/mL, Solution for injection in PFS

EU-Approved XOLAIR

Eligibility Criteria

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

You may qualify if:

• Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to dosing), 18 - 65 years of age (inclusive), with body mass index (BMI) ≥ 19 and ≤ 26 kg/m2, and body weight not \< 45 kg or \> 90 kg at the time of screening.
• Subject should be having serum IgE \< 100 IU/ml at the time of screening,
• Healthy as defined by:
• The absence of clinically significant (in the opinion of the PI/designee) illness or surgery within 4 weeks prior to dosing.
• The absence of febrile (defined by a documented body temperature of 101.5 °F or greater) or infectious illness within 1 week prior to dosing.
• Have a normal 12-lead ECG or one with abnormality considered clinically insignificant.
• Have a normal chest X-ray (P. A. view).
• Have acceptable range of SpO2 concentration (95 % - 100%)
• Females of childbearing potential must be willing to use acceptable contraceptive methods throughout the study, and for 30 days thereafter.
• Females of non-childbearing potential must have undergone sterilization procedures, at least 6 months prior to the first dose or be postmenopausal with amenorrhea for at least 1 year prior to the first dose and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status during screening.
• Capable of providing written informed consent.
• Male subjects willing to follow approved birth control method for the duration of the study, and for 30 days thereafter, such as (a double barrier method) vasectomy, condom with spermicide, condom with diaphragm or abstinence, subject should also not donate sperm during this time.

You may not qualify if:

• Participation in a clinical trial involving the administration of an investigational drug or marketed drug within 90 days prior to initial dosing (90 days for any biologics) or concomitant participation in an investigational study involving no drug administration.
• History of Evidence of parasitic infection.
• Routine doses of the following medications within 60 days prior to screening: oral or parentral corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide.
• History of Intravenous (IV) immunoglobulin G (IVIG), or plasmapheresis within 90 days prior to screening.
• Subjects with current malignancy, history of malignancy, or currently under work-up for suspected malignancy except non-melanoma skin cancer that has been treated or excised and is considered resolved.
• Hypersensitivity to omalizumab or any component of the formulation.
• History of anaphylactic shock.
• History of being on allergy vaccine therapy
• Presence of clinically significant cardiovascular, neurological, psychiatric, metabolic, or other pathological conditions that could interfere with the interpretation of the study results and or compromise the safety of the subjects.
• Positive test for hepatitis B, hepatitis C, or HIV.
• Illicit drug use as evidenced by a positive test for urine drug screen at screening or check -in.
• Positive result for urine alcohol test at screening or at check-in
• Females with positive pregnancy tests at screening or check-in.
• Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study or completing follow-up activities.
• vital sign abnormalities at screening.

Sponsors & Collaborators

• Kashiv BioSciences, LLC: lead

Study Sites (2)

Registered BABE centre

Ahmedabad, Gujarat, 380052, India

Location

Registered BABE Centre

Mahesāna, Gujarat, 384435, India

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This will be double blind study. The order of receiving the Test (T) or Reference product (R1 or R2) for each subject during the study will be based on randomization schedule generated by SAS® version 9.4 or higher, The randomization will be balanced. The randomization code will be kept under controlled access. The study drug will be blinded by the CRO.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This will be parallel group design having single study period

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 9, 2022
• Study Start: July 7, 2022
• Primary Completion: February 21, 2023
• Study Completion: June 30, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)