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

AdAlta Limited1 site in 1 country8 target enrollmentJuly 17, 2023

ConditionsInterstitial Lung Disease Chronic Kidney Diseases

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Interstitial Lung Disease
Sponsor: AdAlta Limited
Enrollment: 8
Locations: 1
Primary Endpoint: Incidence of adverse events that are related to treatment in healthy volunteers [Safety and Tolerability]
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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 (CKD) (Part B). The study will be performed in Australia at up to two clinical sites.

Registry

clinicaltrials.gov

Start Date

July 17, 2023

End Date

February 9, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AdAlta Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 -
•Normal vital signs after ≥ 5 minutes resting supine position:
•\> 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

Exclusion Criteria

•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.
•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 -