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NCT05274802

A Study of ALS-4 in Healthy Adults Subjects

Completed Phase 1 Last updated 25 April 2022
What this trial tests

Phase 1 trial testing ALS-4 in Healthy Subject in 72 participants. Completed in 2 January 2022.

Timeline
20 March 2021
Primary endpoint
22 December 2021
2 January 2022

Quick facts

Lead sponsorAptorum International Limited
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingtriple
Primary purposetreatment
Enrollment72
Start date20 March 2021
Primary completion22 December 2021
Estimated completion2 January 2022
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Aptorum International Limited — full company profile →

Who can join

Adults 18 to 60, any sex, with Healthy Subject. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A Phase I trial to evaluate the safety, tolerability and Pharmacokinetics of ALS-4 (IM032) in a single ascending dose (SAD) and multiple ascending dose (MAD) in healthy adult subjects.

Publications & conference data

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

  1. ESKAPE pathogens: antimicrobial resistance, epidemiology, clinical impact and therapeutics.
    Miller WR, Arias CA. · · 2024 · cited 481× · PMID 38831030 · DOI 10.1038/s41579-024-01054-w
  2. Antibiotics in the clinical pipeline as of December 2022.
    Butler MS, Henderson IR, Capon RJ, Blaskovich MAT. · · 2023 · cited 147× · PMID 37291465 · DOI 10.1038/s41429-023-00629-8
  3. A Review of Antibacterial Candidates with New Modes of Action.
    Butler MS, Vollmer W, Goodall ECA, Capon RJ, et al · · 2024 · cited 49× · PMID 39018341 · DOI 10.1021/acsinfecdis.4c00218
  4. Antibacterials with Novel Chemical Scaffolds in Clinical Development.
    Heimann D, Kohnhäuser D, Kohnhäuser AJ, Brönstrup M. · · 2025 · cited 10× · PMID 39847315 · DOI 10.1007/s40265-024-02137-x

Verify or expand the search:

Other recruiting trials for Healthy Subject

Currently open trials in the same condition.

Other Aptorum International Limited trials

Trials by the same sponsor.

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Data sources for this page

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