HealthyPhase 1NCT05413161
To Compare the PK, PD, Safety & Immunogenicity of ADL-018 in Healthy Subjects
A Phase 1 study testing ADL-018, US-licensed XOLAIR and EU-Approved XOLAIR in people with Healthy, run by Kashiv BioSciences, LLC at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ADL-018, US-licensed XOLAIR and EU-Approved XOLAIR
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 2 sitesIndia
- Study dates
- 7 Jul 2022to 30 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- History of significant alcohol abuse within one year prior to initial dosing or regular use of alcohol (more than 14 units of alcohol per week) within six months prior to initial dosing.
- History of drug abuse or use of illicit/illegal drugs within 1 year prior to initial dosing.
- Donation of plasma within 90 days of dosing; blood donation or significant loss of blood within 90 days of dosing.
- Females who are breast-feeding or lactating.
- Subjects who are on a special diet or who have self-reported a weight loss of more than 15 pounds within 1 month prior to initial dosing at Day 1.
- History of any surgical or medical conditions that could have significantly altered the absorption, distribution, metabolism or excretion of any drug.
Trial locations and contacts
2 sites in 1 country.
India2 sites
Registered BABE centre
Ahmedabad, Gujarat, 380052
Registered BABE Centre
Mahesāna, Gujarat, 384435
About this study
Official title: A Randomized, Double Blind, Three-arm, Parallel Group, Single Dose Comparative PK, PD, Safety and Immunogenicity Study Comparing ADL-018 With US-licensed XOLAIR and EU-Approved XOLAIR in Healthy Adult Subjects
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.
Read the detailed description
This will be a randomized, double blind, three-arm, single dose, parallel group, PK, PD and safety and immunogenicity study in healthy, adult, subjects.
The study objectives will be to compare the pharmacokinetics (PK), pharmacodynamics (PD) and to evaluate safety and immunogenicity of the Test product Vs. US-LICENSED XOLAIR and Test product Vs. EU-APPROVED XOLAIR following single subcutaneous dose in healthy adult subjects.
For the purpose of this study the following eligibility assessments will be carried out before enrollment / during the study of any volunteer in the study.
Assessment criteria should be fulfilled for volunteers to be enrolled in the study. The screening will be carried out only after taking written informed consent from volunteers. Once the subject becomes eligible, will get randomized to receive either ADL-018, US-licensed XOLAIR or EU approved XOLAIR as per the randomization schedule. This will be parallel design so will have only one study period. After dosing, all subjects will go for serial PK sampling as defined in the study protocol. All subjects will be monitored on safety grounds as mentioned in the study protocol.
- Conditions
- Healthy
- Being tested
- ADL-018, US-licensed XOLAIR, EU-Approved XOLAIR
- Keywords
- ADL-018, XOLAIR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADL-018Biological
150 mg/mL, Solution for injection in PFS
US-licensed XOLAIRBiological
150 mg/mL, Solution for injection in PFS
EU-Approved XOLAIRBiological
150 mg/mL, Solution for injection in PFS
| Study group | Role | What they receive |
|---|---|---|
| ADL-018 | Experimental | 150 mg/mL, Solution for injection in PFS Receives: Biological: ADL-018 |
| US-Licensed XOLAIR | Active comparator | 150 mg/mL, Solution for injection in PFS Receives: Biological: US-licensed XOLAIR |
| EU-Approved XOLAIR | Active comparator | 150 mg/mL, Solution for injection in PFS Receives: Biological: EU-Approved XOLAIR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Upto Day 126
Secondary outcomes (7)
Pharmacokinetic Outcome Measures [Tmax]
To assess Time to Cmax (Tmax) of ADL-018, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Measured: Upto Day 126
Pharmacokinetic Outcome Measures [t1/2]
To assess Terminal half-life (t1/2) of ADL-018, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Measured: Upto Day 126
Pharmacokinetic Outcome Measures [Apparent total body clearance (CL/F)]
To assess Apparent total body clearance (CL/F) of ADL-018, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Measured: Upto day 126
Pharmacokinetic Outcome Measures [λz]
To assess Terminal elimination rate constant (λz) of ADL-018, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Measured: Upto day 126
Pharmacokinetic Outcome Measures [Vz/F]
To assess apparent volume of distribution (Vz/F) of ADL-018, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Measured: Upto day 126
Pharmacodynamics [IgE level]
Free IgE and total IgE levels (the sum of free and omalizumab-bound IgE) in the serum samples from subjects
Measured: Upto day 126
ADA incidence rate of ADL-018
Anti drug antibody（ADA）incidence rate of single subcutaneous administration of ADL-018 in comparison with US-licensed XOLAIR and EU-approved XOLAIR in healthy subjects
Measured: Upto day 126
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start7 Jul 2022
- Primary completion21 Feb 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be parallel group design having single study period
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kashiv BioSciences, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413161
- Sponsor's protocol ID
- OMA/2019/1692
- Other IDs
- CTRI/2022/06/043399
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2022
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Three-arm, Parallel Group, Single Dose Comparative PK, PD, Safety and Immunogenicity Study Comparing ADL-018 With US-licensed XOLAIR and EU-Approved XOLAIR in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05413161
- Acronym / sponsor ID
- OMA/2019/1692
- Conditions
- Healthy
- Keywords
- ADL-018, XOLAIR
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Kashiv BioSciences, LLCIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This will be a randomized, double blind, three-arm, single dose, parallel group, PK, PD and safety and immunogenicity study in healthy, adult, subjects.
The study objectives will be to compare the pharmacokinetics (PK), pharmacodynamics (PD) and to evaluate safety and immunogenicity of the Test product Vs. US-LICENSED XOLAIR and Test product Vs. EU-APPROVED XOLAIR following single subcutaneous dose in healthy adult subjects.
For the purpose of this study the following eligibility assessments will be carried out before enrollment / during the study of any volunteer in the study.
Assessment criteria should be fulfilled for volunteers to be enrolled in the study. The screening will be carried out only after taking written informed consent from volunteers. Once the subject becomes eligible, will get randomized to receive either ADL-018, US-licensed XOLAIR or EU approved XOLAIR as per the randomization schedule. This will be parallel design so will have only one study period. After dosing, all subjects will go for serial PK sampling as defined in the study protocol. All subjects will be monitored on safety grounds as mentioned in the study protocol.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This will be parallel group design having single study period
| Arm | Type | Receives |
|---|---|---|
| ADL-018 | Experimental | Biological: ADL-018150 mg/mL, Solution for injection in PFS |
| US-Licensed XOLAIR | Active comparator | Biological: US-licensed XOLAIR150 mg/mL, Solution for injection in PFS |
| EU-Approved XOLAIR | Active comparator | Biological: EU-Approved XOLAIR150 mg/mL, Solution for injection in PFS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Have a normal 12-lead ECG or one with abnormality considered clinically insignificant.
- Have a normal chest X-ray (P. A. view).
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADL-018150 mg/mL, Solution for injection in PFS | Biological | ADL-018 |
| US-licensed XOLAIR150 mg/mL, Solution for injection in PFS | Biological | US-Licensed XOLAIR |
| EU-Approved XOLAIR150 mg/mL, Solution for injection in PFS | Biological | EU-Approved XOLAIR |
Primary outcome
Pharmacokinetic Outcome Measures [Cmax]
Time frame: Upto Day 126
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)
Pharmacokinetic Outcome Measures [AUC0-last]
Time frame: Upto Day 126
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)
Pharmacokinetic Outcome Measures [AUC0-inf]
Time frame: Upto Day 126
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)
Incidence of Adverse events of Special Interest [Safety]
Time frame: Upto Day 126
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)
7 secondary outcomes
Pharmacokinetic Outcome Measures [Tmax]
Time frame: Upto Day 126
Pharmacokinetic Outcome Measures [t1/2]
Time frame: Upto Day 126
Pharmacokinetic Outcome Measures [Apparent total body clearance (CL/F)]
Time frame: Upto day 126
Pharmacokinetic Outcome Measures [λz]
Time frame: Upto day 126
Pharmacokinetic Outcome Measures [Vz/F]
Time frame: Upto day 126
Pharmacodynamics [IgE level]
Time frame: Upto day 126
ADA incidence rate of ADL-018
Time frame: Upto day 126
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No. No plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADL-018, US-licensed XOLAIR and EU-Approved XOLAIR in people with Healthy, run by Kashiv BioSciences, LLC at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Outcome Measures [Cmax] (time frame: Upto Day 126). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.