- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04415671
Phase 1 Safety, Tolerability, PK & PD Study of AD-214 Administered to Healthy Volunteers
May 2, 2022 updated by: AdAlta Limited
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New South Wales
-
Randwick, New South Wales, Australia, 2031
- Scientia Clinical Research Ltd
-
-
South Australia
-
Adelaide, South Australia, Australia, 5000
- CMAX Clinical Research Pty Ltd
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part A- AD-214 SAD in Healthy Volunteers
|
AD-214 is a recombinant Fc-fusion protein that selectively binds to CXCR4 to antagonise the SDF-1/CXCR4 axis.
|
Placebo Comparator: Part A-Placebo SAD in Healthy Volunteers
|
Placebo
|
Experimental: Part B-AD-214 MAD in Healthy Volunteers
|
AD-214 is a recombinant Fc-fusion protein that selectively binds to CXCR4 to antagonise the SDF-1/CXCR4 axis.
|
Placebo Comparator: Part B-Placebo MAD in Healthy Volunteers
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
SAD Part A- 28 days. MAD Part B - 57 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 19, 2020
Primary Completion (Actual)
October 21, 2021
Study Completion (Actual)
February 8, 2022
Study Registration Dates
First Submitted
May 27, 2020
First Submitted That Met QC Criteria
May 31, 2020
First Posted (Actual)
June 4, 2020
Study Record Updates
Last Update Posted (Actual)
May 6, 2022
Last Update Submitted That Met QC Criteria
May 2, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADA-AD-214-1A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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