NCT04689035

A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144

Completed Phase 1 Last updated 20 July 2023

What this trial tests

Phase 1 trial testing AVLX-144 in Safety Issues in 46 participants. Completed in 1 July 2023.

Timeline

27 September 2020

Primary endpoint
1 July 2023

1 July 2023

Quick facts

Lead sponsor	Avilex Pharma
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Enrollment	46
Start date	27 September 2020
Primary completion	1 July 2023
Estimated completion	1 July 2023
Sites	1 location across Finland

Drugs / interventions tested

• AVLX-144 — full drug profile →
• Placebo

Conditions studied

• Safety Issues — all drugs for Safety Issues →
• Tolerance — all drugs for Tolerance →

Sponsor

Avilex Pharma — full company profile →

Who can join

Adults 20 to 80, any sex, with Safety Issues or Tolerance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomised, double-blind, placebo-controlled, single ascending dose study in healthy volunteer subjects. Each dose level will be investigated with eight 20-50-year-old male subjects (6 on active drug and 2 on placebo). Additionally, eight healthy elderly subjects (65-80 years of age, males and females), 6 on active drug and 2 on placebo, will be included in the study at one dose level, once the safety and tolerability of AVLX-144 has been documented in younger subjects.

Publications & conference data

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

1. PSD-95: An Effective Target for Stroke Therapy Using Neuroprotective Peptides.
   Ugalde-Triviño L, Díaz-Guerra M. · · 2021 · cited 56× · PMID 34830481 · DOI 10.3390/ijms222212585
2. Targeting NMDA Receptors at the Neurovascular Unit: Past and Future Treatments for Central Nervous System Diseases.
   Seillier C, Lesept F, Toutirais O, Potzeha F, et al · · 2022 · cited 26× · PMID 36142247 · DOI 10.3390/ijms231810336
3. The Scaffold Protein PICK1 as a Target in Chronic Pain.
   Sørensen AT, Rombach J, Gether U, Madsen KL. · · 2022 · cited 10× · PMID 35455935 · DOI 10.3390/cells11081255
4. Multivalent binding kinetics resolved by fluorescence proximity sensing.
   Schulte C, Soldà A, Spänig S, Adams N, et al · · 2022 · cited 9× · PMID 36207490 · DOI 10.1038/s42003-022-03997-3