NCT05528315 is a Phase 1 clinical trial of ABX-002 in MDD, sponsored by Autobahn Therapeutics, Inc..

Who is sponsoring NCT05528315?

NCT05528315 is sponsored by Autobahn Therapeutics, Inc..

What drugs are being tested in NCT05528315?

Interventions in NCT05528315: ABX-002, Placebo.

Is NCT05528315 still recruiting?

NCT05528315 is currently completed. Last updated 15 September 2023.

Last reviewed 2023-09-15 · How we verify

NCT05528315

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

SAD/MAD of ABX-002-1902 Investigating the Safety, Pharmacokinetics/Pharmacodynamics of in Healthy Subjects

Completed Phase 1 Last updated 15 September 2023

What this trial tests

Phase 1 trial testing ABX-002 in MDD in 48 participants. Completed in 13 September 2023.

Timeline

12 October 2022

Primary endpoint
26 June 2023

13 September 2023

Quick facts

Lead sponsor	Autobahn Therapeutics, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	triple
Primary purpose	treatment
Enrollment	48
Start date	12 October 2022
Primary completion	26 June 2023
Estimated completion	13 September 2023
Sites	1 location across Australia

Drugs / interventions tested

ABX-002 — full drug profile →
Placebo

Conditions studied

MDD — all drugs for MDD →

Sponsor

Autobahn Therapeutics, Inc.

Who can join

Adults 18 to 55, any sex, with MDD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study will evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single-ascending doses (SAD) and multiple ascending doses (MAD) of ABX-002 in healthy volunteers (HV)

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of ABX-002

Trials testing the same drug.

NCT06869187 — Study of ABX-002 for the Adjunctive Treatment of Depressive Episodes Associated With Bipolar Disorder in Adults · Phase 2 · recruiting

Other recruiting trials for MDD

Currently open trials in the same condition.

NCT07422844 — Dynamic Network Response to TMS Treatment · recruiting
NCT07111390 — Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD) · NA · recruiting
NCT06828887 — Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LV232 Capsules in the Treatment of MDD · Phase 2 · recruiting
NCT06132178 — Psilocybin rTMS for Treatment Resistant Depression · Phase 2 · recruiting
NCT07269964 — At-Home tDCS as Maintenance Therapy · NA · recruiting

Other Autobahn Therapeutics, Inc. trials

Trials by the same sponsor.

NCT06869187 — Study of ABX-002 for the Adjunctive Treatment of Depressive Episodes Associated With Bipolar Disorder in Adults · Phase 2 · recruiting

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 NCT05528315 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Autobahn Therapeutics, Inc.
Last refreshed: 15 September 2023

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/NCT05528315.

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