Interstitial Lung DiseasePhase 1NCT05914909
Safety, Tolerability, PK and PD Study of AD-214 Administered to Healthy Volunteers and Patients With Interstitial Lung Disease or Chronic Kidney Disease
A Phase 1 study testing AD-214 in people with Interstitial Lung Disease and Chronic Kidney Diseases, run by AdAlta Limited at 1 site in Australia.
Trial summary
This is a Phase I, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of a 10 mg/kg dose of AD-214 when administered to healthy volunteers (HVs) (Part A) or patients with interstitial lung disease (ILD) or chronic kidney disease… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Interstitial Lung Disease, Chronic Kidney Diseases
- What is being tested?
- AD-214
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteAustralia
- Study dates
- 17 Jul 2023to 9 Feb 2024
- 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
- All Study Parts:
- Male or female aged ≥ 18 to ≤ 65 years of age at the time of consent.
- Provision of signed informed consent prior to study entry and agreement to adhere to all study protocol requirements.
- Agreement to adhere to the current state and national advice regarding minimising exposure to corona virus disease from the first screening visit until the EoS visit.
- Maximum weight of 100.00 kg and BMI > 18.0 and < 30.0 kg/m2 (inclusive) at the time of consent. Participants must also be < 100.00 kg at Day -1.
- Normal vital signs after ≥ 5 minutes resting supine position:
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- > 90 mmHg and <160 mmHg SBP
- 50 mmHg and < 95 mmHg DBP
- > 45 bpm and < 101 bpm HR
- Body temperature >35.5oC and ≤37.6°C
- Ability and willingness to attend the necessary visits to the CRU.
- Have established use of highly effective, double barrier contraception (both partners) prior to screening, during the study AND for 90 days following completion of dosing as specified below in this criterion.
- Double barrier contraception is defined as a condom AND 1 other form of the following:
- Hormonal and non-hormonal forms of contraception (including oral, depot or injectable)
- IUD/IUS
- Sterilised male partner. Rhythm methods will not be considered as highly effective methods of birth control.
- Participant abstinence from heterosexual sexual activity, if their usual and preferred lifestyle, for the duration of the study and for 90 days after the last dose of AD-214 is acceptable.
- Participants who are in a same sex relationship will not require contraception unless they enter into a heterosexual relationship.
- Female participants and female partners of male participants must use double barrier contraception including condom from start of study and for 90 days after last dose of AD-214.
- Male participants must refrain from sperm donation and female participants must refrain from ova donation from the first dose of AD-214 and for 90 days after last dose of AD-214.
- WOCBP must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1. Females not of childbearing potential must be surgically sterile or post-menopausal (defined as cessation of regular menstrual periods for at least 12 months), confirmed by FSH level at Screening.
- Must not regularly consume more than 10 standard alcoholic drinks in a week and more than 4 standard alcoholic drinks in any one day for the duration of the study, AND must for the duration of the study agree to:
- abstain from alcohol intake from 48 hours before each study drug administration through to discharge from the CRU AND
- abstain from alcohol intake from 24 hours before each outpatient study visit.
- Must not be a regular smoker of > 5 cigarettes/e-cigarettes/cigars/pipes a day AND must, for the duration of the study, agree to:
- smoke no more than 5 cigarettes/ e-cigarettes/cigars/pipes in any 1 day from 48 hours before first study drug administration until the EoS visit
- abstain from smoking 24 hours before each study drug administration through to discharge from the CRU
- abstain from smoking from 24 hours before each outpatient study visit.
- Part A: HVs only
- Must be in good general health, in the opinion of the Investigator, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening, and/or before administration of the initial dose of study drug.
- Must have clinical laboratory values within normal range in the opinion of the Investigator. Repeat screening may be permitted if out of range values are deemed NCS by the Investigator. Exercise induced elevated creatinine kinase levels may be permitted if out of range values are deemed NCS by the Investigator.
- Part B: Patients with ILD or CKD
- Clinical and radiological features that are consistent with an established diagnosis of any of the following diseases in which high expression of CXCR4 has been implicated ;
- CKD due to LN, DN, and FSGS OR
- IPF OR fibrotic ILD associated with any of the following: CVD, Fibrotic non-specific interstitial pneumonia (fNSIP), Chronic fibrosing hypersensitivity pneumonitis (cHP)
- Must be on a stable regimen of systemic medications for their ILD or CKD and expected to continue on this regimen until completion of the final EoS visit.
- Patients with ILD:
- Most recent HRCT image (taken within 12 months of Screening) showing either UIP pattern as per current ATS/ ERS/ JRS/ALAT guidelines in IPF patients, OR, for patients with fibrotic ILD, a > 10% extent of fibrosing lung disease.
- Predicted FVC ≥ 50% on PFTs conducted within 3 months of Screening.
- Predicted haemoglobin-corrected DLCO ≥ 25% in PFTs conducted within 6 months of Screening.
- Patients with CKD:
- Estimated glomerular filtration rate greater than or equal to 30 mL/min/1.73 m2
- Proteinuria ≥ 1 based on absolute amount in grams per day (g/d) as measured in 1 complete and valid 24-hour urine collection during Screening.
Who cannot join
- All Study Parts:
- Previously received AD-214
- Received any IMP within 30 days or 5 half-lives prior to Screening, whichever is longer.
- Received an investigational vaccine, recombinant protein or monoclonal antibody within 6 months, a live attenuated registered vaccine within 60 days, or a registered vaccine within 30 days prior to the first dose of the IP.
- Received blood or blood products within 1 month prior to Screening.
- Blood donation or significant blood loss (> 280 mL) within 60 days prior to the first dose of the IP.
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- Plasma donation within 7 days prior to the first dose of the IP.
- A bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with blood draws.
- Unable to provide a blood sample without undue trauma or distress or inadequate venous access.
- Recent (less than 6 weeks) significant wound (in the opinion of the PI), or presence of an ongoing non-healing skin wound on Day -1.
- Positive test for HIV, HBsAg, or anti-HCV at Screening.
- A psychiatric condition that precludes compliance with the protocol in the opinion of the Investigator; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within 5 years prior to Screening, a history of suicide plan.
- Clinical signs of active infection and/or a temperature of > 37.7°C at the time of Screening. Study entry may be deferred at the discretion of the PI.
- Fever in the past 7 days within Screening or Day 1 AND symptoms reflective of an active respiratory tract infection (in the opinion of the Investigator).
- QTcF > 450 msec for females and > 470 msec for males, or QTcF > 480 msec in participants with Bundle Branch Block.
- Active malignancy and/or history of malignancy in the past 5 years, with the exception of non-melanoma skin cancer, or low grade cervical intraepithelial neoplasia.
- A history of severe allergic, anaphylactic, or other hypersensitive reactions to AD-214 excipients, a history of drug or other allergy including severe allergic reaction that in the opinion of the Investigator or Sponsor MM contraindicates their participation.
- Surgery within the past 3 months prior to the first study drug administration determined by the PI to be clinically relevant.
- History or presence of alcohol abuse (defined as an average weekly intake of > 10 units. One unit is equivalent to 10 g of alcohol and the following can be used as a guide: a half-pint [~240 mL] of beer, 1 glass [125 mL] of wine or 1 [30 mL] measure of spirits) or drug abuse (including recreational marijuana use) within the 2 years prior to the first study drug administration, and unwillingness to be totally abstinent during the dosing period.
- Positive alcohol breath test or urine drugs of abuse screen at Screening or Day -1
- Inability to adhere to smoking and alcohol restrictions for the duration of the study.
- Pregnant or lactating.
- Part A: HVs:
- Any clinically significant abnormality at Screening determined by medical history, physical examination, biochemistry, haematology, coagulation, urinalysis, and 12-lead ECG.
- History of recurrent infections, with the exception of urinary tract infections.
- Serious (as per the discretion of the PI or Investigator) local infection or systemic infection requiring antibiotic or anti-viral treatment within 3 months from Screening.
- Extensive chronic obstructive pulmonary disease including emphysema and chronic bronchitis as judged by the PI or Investigator.
- A history of or current chronic medical condition (eg, hypertension, asthma, diabetes, or cardiac disease) or any other medical, social, or psychiatric condition, significant co-morbidities, or any finding during Screening, which in the Investigator's opinion may interfere with the study objectives, may put the participant at risk, or may make the participant unsuitable for participation in the study.
- Use of any prescription or over the counter medication (with the exception of paracetamol and contraceptives) within 7 days of first study drug administration.
- Any acute illness within 30 days prior to Day 1.
- Part B:
- All Patients
- Alanine aminotransferase (ALT) > 2 × ULN and total bilirubin > 1.5 × ULN.
- Use of anticoagulants or antiplatelet agents (excluding aspirin).
- Severe/significant arterial hypertension, heart failure or coronary heart disease.
- Significant hypoxia, requiring > 2 L/min oxygen chronically to maintain a resting oxygen saturation > 89%.
- Patients with ILD
- Poor exercise tolerance with 6MWD < 150 metres.
- Extensive emphysema on HRCT as defined by being greater in extent than the accompanying fibrotic lung disease.
- Evidence of physiologically significant obstructive airways disease as evident from
- FEV1/FVC ratio < 0.7 OR
- Bronchodilator response defined by an increase of ≥ 12% and an increase of ≥ 200 mL in the FEV1 after bronchodilator
- Other explanation for lung fibrosis, including but not limited to radiation, sarcoidosis, bronchiolitis obliterans organising pneumonia, HIV, viral hepatitis.
- Patients with CKD
- Post-transplant patients
Trial locations and contacts
1 site in 1 country.
Australia1 site
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000
About this study
Official title: A Phase 1, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of 10 mg/kg AD-214 When Administered Intravenously to Healthy Volunteers and Patients With Interstitial Lung Disease or Chronic Kidney Disease
This is a Phase I, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of a 10 mg/kg dose of AD-214 when administered to healthy volunteers (HVs) (Part A) or patients with interstitial lung disease (ILD) or chronic kidney disease (CKD) (Part B). The study will be performed in Australia at up to two clinical sites.
- Conditions
- Interstitial Lung Disease, Chronic Kidney Diseases
- Being tested
- AD-214, Placebo
- Medical subject headings
- Lung Diseases, Interstitial, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-214Biological
AD-214 is a recombinant Fc-fusion protein that selectively binds to CXCR4 to antagonise the SDF-1/CXCR4 axis.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part A: AD-214 in Healthy Volunteers | Experimental | Not described Receives: Biological: AD-214 |
| Part A: Placebo in Healthy Volunteers | Placebo comparator | Not described Receives: Other: Placebo |
| Part B: AD-214 in patients with ILD or CKD | Experimental | Not described Receives: Biological: AD-214 |
| Part B: Placebo in patients with ILD or CKD | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events that are related to treatment in healthy volunteers [Safety and Tolerability]
Safety and Tolerability as assessed by the number of adverse events that are related to treatment versus placebo
Measured: 141 days
Incidence of adverse events that are related to treatment in patients with ILD or CKD [Safety and Tolerability]
Safety and Tolerability as assessed by the number of adverse events that are related to treatment versus placebo
Measured: 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start17 Jul 2023
- Primary completion9 Feb 2024
- Study completion9 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdAlta Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emir Redzepagic, Dr, Principal investigator, CMAX Clinical Research Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914909
- Sponsor's protocol ID
- 1AD-AD-214-2301
- Status last verified
- Feb 2024
- First submitted
- 28 May 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of 10 mg/kg AD-214 When Administered Intravenously to Healthy Volunteers and Patients With Interstitial Lung Disease or Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05914909
- Acronym / sponsor ID
- 1AD-AD-214-2301
- Conditions
- Interstitial Lung Disease, Chronic Kidney Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- AdAlta LimitedIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 9 Feb 2024 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 22 Jun 2023 (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 is a Phase I, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of a 10 mg/kg dose of AD-214 when administered to healthy volunteers (HVs) (Part A) or patients with interstitial lung disease (ILD) or chronic kidney disease (CKD) (Part B). The study will be performed in Australia at up to two clinical sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: AD-214 in Healthy Volunteers | Experimental | Biological: AD-214 |
| Part A: Placebo in Healthy Volunteers | Placebo comparator | Other: Placebo |
| Part B: AD-214 in patients with ILD or CKD | Experimental | Biological: AD-214 |
| Part B: Placebo in patients with ILD or CKD | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (43 listed)
- All Study Parts:
- Participant abstinence from heterosexual sexual activity, if their usual and preferred lifestyle, for the duration of the study and for 90 days after the last dose of AD-214 is acceptable.
- Participants who are in a same sex relationship will not require contraception unless they enter into a heterosexual relationship.
- Female participants and female partners of male participants must use double barrier contraception including condom from start of study and for 90 days after last dose of AD-214.
- Part A: HVs only
Key exclusion criteria (45 listed)
- All Study Parts:
- All Patients
- Patients with ILD
- Patients with CKD
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 |
|---|---|---|
| AD-214AD-214 is a recombinant Fc-fusion protein that selectively binds to CXCR4 to antagonise the SDF-1/CXCR4 axis. | Biological | Part A: AD-214 in Healthy Volunteers, Part B: AD-214 in patients with ILD or CKD |
| PlaceboPlacebo | Other | Part A: Placebo in Healthy Volunteers, Part B: Placebo in patients with ILD or CKD |
Primary outcome
Incidence of adverse events that are related to treatment in healthy volunteers [Safety and Tolerability]
Time frame: 141 days
Safety and Tolerability as assessed by the number of adverse events that are related to treatment versus placebo
Incidence of adverse events that are related to treatment in patients with ILD or CKD [Safety and Tolerability]
Time frame: 57 days
Safety and Tolerability as assessed by the number of adverse events that are related to treatment versus placebo
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 13 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Emir Redzepagic, Dr principal investigator
CMAX Clinical Research Pty Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AD-214 in people with Interstitial Lung Disease and Chronic Kidney Diseases, run by AdAlta Limited at 1 site in Australia.
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 43 inclusion and 45 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 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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. Some participants in this study may receive a placebo. 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?
Incidence of adverse events that are related to treatment in healthy volunteers [Safety and Tolerability] (time frame: 141 days). The study lists 2 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 13 Feb 2024.