NCT04415671 is a Phase 1 clinical trial of AD-214 in Interstitial Lung Disease, sponsored by AdAlta Limited.

Who is sponsoring NCT04415671?

NCT04415671 is sponsored by AdAlta Limited.

What drugs are being tested in NCT04415671?

Interventions in NCT04415671: AD-214, Placebo.

What condition does NCT04415671 study?

NCT04415671 studies Interstitial Lung Disease.

Is NCT04415671 still recruiting?

NCT04415671 is currently completed. Last updated 6 May 2022.

Last reviewed 2022-05-06 · How we verify

NCT04415671

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 6 May 2022

What this trial tests

Phase 1 trial testing AD-214 in Interstitial Lung Disease in 50 participants. Completed in 8 February 2022.

Timeline

19 June 2020

Primary endpoint
21 October 2021

8 February 2022

Quick facts

Lead sponsor	AdAlta Limited
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	50
Start date	19 June 2020
Primary completion	21 October 2021
Estimated completion	8 February 2022
Sites	2 locations across Australia

Drugs / interventions tested

AD-214 — full drug profile →
Placebo

Conditions studied

Interstitial Lung Disease — all drugs for Interstitial Lung Disease →

Sponsor

AdAlta Limited

Who can join

Adults 18 to 65, any sex, with Interstitial Lung Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Breaking barriers in antibody discovery: harnessing divergent species for accessing difficult and conserved drug targets.
Banik SSR, Kushnir N, Doranz BJ, Chambers R. · · 2023 · cited 9× · PMID 38050985 · DOI 10.1080/19420862.2023.2273018
A broadly cross-reactive i-body to AMA1 potently inhibits blood and liver stages of Plasmodium parasites.
Angage D, Chmielewski J, Maddumage JC, Hesping E, et al · · 2024 · cited 6× · PMID 39174515 · DOI 10.1038/s41467-024-50770-7
PROSCA: an online platform for humanized scaffold mining facilitating rational protein engineering.
Wang X, Zhang Y, Li Z, Duan Z, et al · · 2024 · cited 5× · PMID 38738624 · DOI 10.1093/nar/gkae384
Development and characterization of AD-214, an anti-CXCR4 i-body-Fc fusion for the treatment of idiopathic pulmonary fibrosis.
Lynch JP, Organ L, Tomusange K, Kowalczyk L, et al · · 2025 · cited 2× · PMID 40395177 · DOI 10.1080/19420862.2025.2505090

Verify or expand the search:

Other trials of AD-214

Trials testing the same drug.

NCT05914909 — Safety, Tolerability, PK and PD Study of AD-214 Administered to Healthy Volunteers and Patients With Interstitial Lung D · Phase 1 · completed
NCT05062876 — A Study to Compare PK, PD and Safety of the AD-214 and AD-2141 · Phase 1 · completed

Other recruiting trials for Interstitial Lung Disease

Currently open trials in the same condition.

NCT07451977 — Effects of Oxygen Supplementation During the 6-Minute Walk Test in Chronic Respiratory Failure or Exertional Hypoxemia · NA · recruiting
NCT07254338 — Exploration of Metabolome in Patients With Interstitial Lung Disease and Pulmonary Hypertension With or Without Specific · recruiting
NCT07269262 — SUPPORT-T in Patients With Progressive Pulmonary Fibrosis and Their Caregivers · NA · recruiting
NCT07179380 — Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension · Phase 3 · recruiting
NCT07323732 — A Study of BIO 300 and Thoracic Radiation Therapy in People With Non-Small Cell Lung Cancer and Interstitial Lung Diseas · Phase 2 · recruiting

Other AdAlta Limited trials

Trials by the same sponsor.

NCT05914909 — Safety, Tolerability, PK and PD Study of AD-214 Administered to Healthy Volunteers and Patients With Interstitial Lung D · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04415671 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AdAlta Limited
Last refreshed: 6 May 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04415671.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing