Phase 1 Safety, Tolerability, PK & PD Study of AD-214 Administered to Healthy Volunteers and Patients With ILD

Study Purpose

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) and to patients with Interstitial Lung Disease (ILD). The study in HVs will be single ascending dose (SAD), randomized, double blind, and placebo-controlled (Part A). The study in ILD patients will be open-label, SAD (Part B), and multiple ascending dose (MAD) (Part C).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

All Study Parts: 1. Must provide signed informed consent prior to study entry and agree to adhere to all study protocol requirements. 2. Maximum weight of 100 kg at the time of consent and body mass index (BMI) >18 and < 30 kg/m2 (inclusive) 3. Must agree to abstain from alcohol intake from 48 hours before first study drug administration through to final study visit 4. Must agree to abstain from smoking from 48 hours before first study drug administration through to final study visit 5. Must have a negative urine drug screen and cotinine test, and alcohol breath test at Screening and on Day -1 (admission). 6. 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 7. Male participants must refrain from sperm donation from start of study and for 90 days after last dose of AD-214 8. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1. Part A (SAD) in Healthy Volunteers: 9. 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. 10. 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. Part B (SAD) and Part C (MAD) (Interstitial Lung Disease): 11. Patients with clinical and radiological features that in the opinion of the PI are consistent with a diagnosis of fibrotic ILD associated with idiopathic pulmonary fibrosis (IPF), Collagen-vascular disease (CVD), Fibrotic non-specific interstitial pneumonia (fNSIP) or Chronic fibrosing hypersensitivity pneumonitis (cHP). 12. Predicted forced vital capacity (FVC) ≥ 50% on pulmonary function tests (PFTs) conducted within 3 months of Screening. 13. Predicted haemoglobin-corrected diffusing capacity of the lung for carbon monoxide (DLCO) ≥ 25% in PFTs conducted within 6 months of Screening.

Exclusion Criteria:

All Study Parts: 1. 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 2. 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. 3. Received blood products within 1 month prior to Screening. 4. Blood donation or significant blood loss (> 450 mL) within 60 days prior to the first administration of investigational product 5. Plasma donation within 7 days prior to the first administration of investigational product. 6. A bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with blood draws. 7. Known history of Human Immunodeficiency Virus (HIV) or HIV antibody positive. 8. 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. 9. Any clinically significant abnormality at Screening determined by medical history, physical examination, blood chemistry, hematology, coagulation, urinalysis and 12-lead electrocardiogram (ECG). 10. 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. 11. Surgery within the past 3 months prior to the first study drug administration determined by the PI to be clinically relevant. 12. History or presence of alcohol or drug abuse 13. Females who are pregnant or lactating. Part A (SAD) in Healthy Volunteers: 14. Use of any prescription or over the counter medication (with the exception of paracetamol and contraceptives) within 7 days of first study drug administration. Part B (SAD) and Part C (MAD) in Patients with Interstitial Lung Disease: 15. Received nintedanib or pirfenidone or other systemic medications for their ILD within 30 days of Day -1. Ongoing use of systemic corticosteroids (prednisolone or equivalent) at a dose of ≤ 10 mg/day is permitted. 16. Evidence of significant deterioration in pulmonary function in the preceding 30 days at Screening and on Day -1. 17. Significant hypoxia, requiring >2 L/min oxygen chronically to maintain a resting oxygen saturation >89% (at Screening). 18. Poor exercise tolerance with 6 Minute Walking Distance (6MWD) < 150 m (at Screening). 19. Extensive emphysema on HRCT as defined by being greater in extent than the accompanying fibrotic lung disease. 20. Evidence of physiologically significant obstructive airways disease 21. Other explanation for lung fibrosis, including but not limited to radiation, sarcoidosis, bronchiolitis obliterans organizing pneumonia. 22. Alanine transferase (ALT) >2 x ULN OR total bilirubin >1.5 x ULN at screening. 23. Use of anticoagulants or antiplatelet agents (excluding aspirin) at Screening and Day -1.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04415671
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AdAlta Limited
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Interstitial Lung Disease
Arms & Interventions

Arms

Experimental: Part A- AD-214 SAD in Healthy Volunteers

Placebo Comparator: Part A-Placebo SAD in Healthy Volunteers

Experimental: Part B- AD-214 SAD in patients with ILD

Experimental: Part C-AD-214 MAD in patients with ILD

Interventions

Biological: - AD-214

AD-214 is a recombinant Fc-fusion protein that selectively binds to CXCR4 to antagonise the SDF-1/CXCR4 axis.

Other: - Placebo

Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Scientia Clinical Research Ltd, Randwick, New South Wales, Australia

Status

Not yet recruiting

Address

Scientia Clinical Research Ltd

Randwick, New South Wales, 2031

CMAX Clinical Research Pty Ltd, Adelaide, South Australia, Australia

Status

Recruiting

Address

CMAX Clinical Research Pty Ltd

Adelaide, South Australia, 5000

Site Contact

Dianne Pepper

dianne.pepper@cmax.com.au

+61 8 7088 7939

Terms of Service

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