Interstitial Lung DiseasePhase 1NCT04415671
Phase 1 Safety, Tolerability, PK & PD Study of AD-214 Administered to Healthy Volunteers
A Phase 1 study testing AD-214 in people with Interstitial Lung Disease, run by AdAlta Limited at 2 sites in Australia.
Trial summary
This is a first in human (FIH), multi-center, dose escalating study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of AD-214 when administered to healthy volunteers (HVs). 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
- What is being tested?
- AD-214
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesAustralia
- Study dates
- 19 Jun 2020to 8 Feb 2022
- 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
- Must provide signed informed consent prior to study entry and agree to adhere to all study protocol requirements.
- Maximum weight of 100 kg at the time of consent and body mass index (BMI) >18 and < 30 kg/m2 (inclusive)
- Must agree to abstain from alcohol intake from 48 hours before first study drug administration through to final study visit
- Must agree to abstain from smoking from 48 hours before first study drug administration through to final study visit
- Must have a negative urine drug screen and cotinine test, and alcohol breath test at Screening and on Day -1 (admission).
- Must agree to use highly effective, double barrier contraception (both male and female partners) at least 30 days prior to dosing on day 1, during the study AND for 90 days following completion of dosing
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- Male participants must refrain from sperm donation from start of study and for 90 days after last dose of AD-214
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1.
- Participants must be in good general health, with no significant medical history, and no clinically significant abnormalities on physical examination at Screening, and/or before administration of the initial dose of study drug.
- Participants must have clinical laboratory values within normal range or < 1.5 x upper limit of normal (ULN) as specified by the testing laboratory at Screening.
Who cannot join
- Received any Investigational Medicinal Product (IMP) within 30 days (4 months if the previous drug was a new chemical entity) or 5 half-lives prior to Screening
- Received an investigational vaccine within 6 months, a live attenuated vaccine within 60 days or a registered vaccine within 30 days prior to the first dose of the investigational product.
- Received blood products within 1 month prior to Screening.
- Blood donation or significant blood loss (> 450 mL) within 60 days prior to the first administration of investigational product
- Plasma donation within 7 days prior to the first administration of investigational product.
- A bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with blood draws.
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- Known history of Human Immunodeficiency Virus (HIV) or HIV antibody positive.
- Hepatitis B surface Antigen (HBsAg) positive or Hepatitis B Virus (HBV) polymerase chain reaction (PCR) positivity. Hepatitis C Virus (HCV) antibody positive or HCV PCR positivity.
- Any clinically significant abnormality at Screening determined by medical history, physical examination, blood chemistry, hematology, coagulation, urinalysis and 12-lead electrocardiogram (ECG).
- A history of or current clinically significant gastrointestinal, hepatic, renal, cardiovascular, respiratory (apart from ILD), endocrine, oncological, immunodeficiency, neurological, metabolic, hematological, autoimmune or social or psychiatric condition 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.
- 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 or drug abuse
- Females who are pregnant or lactating.
- Use of any prescription or over the counter medication (with the exception of paracetamol and contraceptives) within 7 days of first study drug administration.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000
Scientia Clinical Research Ltd
Randwick, New South Wales, 2031
About this study
Official title: A Phase 1, Dose-escalating Study of the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Doses of AD-214 When Administered Intravenously to Healthy Volunteers
This is a first in human (FIH), multi-center, dose escalating study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of AD-214 when administered to healthy volunteers (HVs). The study in HVs will be a randomized, double blind, and placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) (Part B) study.
- Conditions
- Interstitial Lung Disease
- Being tested
- AD-214, Placebo
- Medical subject headings
- Lung Diseases, Interstitial
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 SAD in Healthy Volunteers | Experimental | Not described Receives: Biological: AD-214 |
| Part A-Placebo SAD in Healthy Volunteers | Placebo comparator | Not described Receives: Other: Placebo |
| Part B-AD-214 MAD in Healthy Volunteers | Experimental | Not described Receives: Biological: AD-214 |
| Part B-Placebo MAD in Healthy Volunteers | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability as assessed by the number of abnormal laboratory values and/or adverse events that are related to treatment
Measured: SAD Part A- 28 days. MAD Part B - 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start19 Jun 2020
- Primary completion21 Oct 2021
- Study completion8 Feb 2022
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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdAlta Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415671
- Sponsor's protocol ID
- ADA-AD-214-1A
- Status last verified
- May 2022
- First submitted
- 27 May 2020
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Dose-escalating Study of the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Doses of AD-214 When Administered Intravenously to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04415671
- Acronym / sponsor ID
- ADA-AD-214-1A
- Conditions
- Interstitial Lung Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- AdAlta LimitedIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 21 Oct 2021 (actual)
- Study completion
- 8 Feb 2022 (actual)
- First posted
- 4 Jun 2020 (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 first in human (FIH), multi-center, dose escalating study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of AD-214 when administered to healthy volunteers (HVs). The study in HVs will be a randomized, double blind, and placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) (Part B) study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A- AD-214 SAD in Healthy Volunteers | Experimental | Biological: AD-214 |
| Part A-Placebo SAD in Healthy Volunteers | Placebo comparator | Other: Placebo |
| Part B-AD-214 MAD in Healthy Volunteers | Experimental | Biological: AD-214 |
| Part B-Placebo MAD in Healthy Volunteers | 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 (10 listed)
- Must provide signed informed consent prior to study entry and agree to adhere to all study protocol requirements.
- Maximum weight of 100 kg at the time of consent and body mass index (BMI) >18 and < 30 kg/m2 (inclusive)
- Must agree to abstain from alcohol intake from 48 hours before first study drug administration through to final study visit
- Must agree to abstain from smoking from 48 hours before first study drug administration through to final study visit
- Must have a negative urine drug screen and cotinine test, and alcohol breath test at Screening and on Day -1 (admission).
Key exclusion criteria (14 listed)
- Received any Investigational Medicinal Product (IMP) within 30 days (4 months if the previous drug was a new chemical entity) or 5 half-lives prior to Screening
- Received an investigational vaccine within 6 months, a live attenuated vaccine within 60 days or a registered vaccine within 30 days prior to the first dose of the investigational product.
- Received blood products within 1 month prior to Screening.
- Blood donation or significant blood loss (> 450 mL) within 60 days prior to the first administration of investigational product
- Plasma donation within 7 days prior to the first administration of investigational product.
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 SAD in Healthy Volunteers, Part B-AD-214 MAD in Healthy Volunteers |
| PlaceboPlacebo | Other | Part A-Placebo SAD in Healthy Volunteers, Part B-Placebo MAD in Healthy Volunteers |
Primary outcome
Safety and Tolerability as assessed by the number of abnormal laboratory values and/or adverse events that are related to treatment
Time frame: SAD Part A- 28 days. MAD Part B - 57 days
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 6 May 2022.
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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 AD-214 in people with Interstitial Lung Disease, run by AdAlta Limited at 2 sites 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 10 inclusion and 14 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 6 May 2022. 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 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?
Safety and Tolerability as assessed by the number of abnormal laboratory values and/or adverse events that are related to treatment (time frame: SAD Part A- 28 days. MAD Part B - 57 days). 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 6 May 2022.