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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04415671




Registration number
NCT04415671
Ethics application status
Date submitted
27/05/2020
Date registered
4/06/2020
Date last updated
19/03/2021

Titles & IDs
Public title
Phase 1 Safety, Tolerability, PK & PD Study of AD-214 Administered to Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
ADA-AD-214-1A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Interstitial Lung Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - AD-214
Other interventions - Placebo

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

Placebo Comparator: Part A-Placebo SAD in Healthy Volunteers -

Experimental: Part B-AD-214 MAD in Healthy Volunteers -

Placebo Comparator: Part B-Placebo MAD in Healthy Volunteers -


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

Other interventions: Placebo
Placebo

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Tolerability as assessed by the number of abnormal laboratory values and/or adverse events that are related to treatment
Timepoint [1] 0 0
SAD Part A- 28 days. MAD Part B - 57 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Scientia Clinical Research Ltd - Randwick
Recruitment hospital [2] 0 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AdAlta Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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). 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.
Trial website
https://clinicaltrials.gov/show/NCT04415671
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Claudia C Gregorio-King, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 3 9479 5159
Fax 0 0
Email 0 0
clinical@adalta.com.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04415671