Evidence map›Paper›PMID 38353689›Full record

Trial reportEuropean journal of clinical pharmacology2024

ACD856, a novel positive allosteric modulator of Trk receptors, single ascending doses in healthy subjects: Safety and pharmacokinetics.

Boel Nilsson, Johan Bylund, Magnus M Halldin, Matthias Rother, Erik Rein-Hedin, Kristin Önnestam, Märta Segerdahl

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05077631 phase1completednot on this map

A Phase I, Double-Blind, Placebo-controlled, Randomized Study to Evaluate the Effects of Single Ascending Oral Doses of ACD856 on Safety, Tolerability and Pharmacokinetics in Healthy Adults

TypeinterventionalSponsorAlzeCure PharmaRan2021 to 2022Enrolled56ConditionsAlzheimer Disease, Cognition DisorderArmsACD856, Placebo, ACD856 (fed cohort)
NCT05783830 early_phase1completednot on this map

A Phase 0, Open-label, Non-controlled Study to Evaluate the Pharmacokinetics of a Single Intravenous Microdose of ACD856 in Healthy Volunteers

TypeinterventionalSponsorAlzeCure PharmaRan2020 to 2020Enrolled6ConditionsCognition Disorder, Alzheimer DiseaseArmsACD856
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Review
  3. Small-Molecule Trk Agonists: Where Do We Go from Here?Journal of medicinal chemistry · 2025
    Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Boel NilssonAlzeCure Pharma AB, Hälsovägen 7, SE-141 57, Huddinge, Sweden.
Johan BylundCTC Clinical Trial Consultants AB, Dag Hammarskjölds väg 10B, SE-752 37, Uppsala, Sweden.
Magnus M HalldinAlzeCure Pharma AB, Hälsovägen 7, SE-141 57, Huddinge, Sweden.
Matthias RotherAlzeCure Pharma AB, Hälsovägen 7, SE-141 57, Huddinge, Sweden.
Erik Rein-HedinCTC Clinical Trial Consultants AB, Dag Hammarskjölds väg 10B, SE-752 37, Uppsala, Sweden.
Kristin ÖnnestamAlzeCure Pharma AB, Hälsovägen 7, SE-141 57, Huddinge, Sweden.
Märta SegerdahlAlzeCure Pharma AB, Hälsovägen 7, SE-141 57, Huddinge, Sweden. marta.segerdahl@alzecurepharma.com.
AlzeCure Pharma (Sweden) · SEUppsala University · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAlzeCure Pharma AB is developing novel positive allosteric modulators of Trk-receptors for treatment of Alzheimer's disease, depression, other psychiatric conditions and other disorders where cognition is impaired. The preceding candidate drug ACD855 was shown to have a too long half-life in humans to allow further development. To de-risk the development of the follow-up compound ACD856, the oral single ascending dose study of ACD856 in humans was preceded by an intravenous microdose study, assessing the elimination half-life in plasma.

methodsA phase 0 study with a microdose of ACD856 (0.100 mg), was conducted in six healthy male subjects all receiving ACD856. Sequentially, a randomized, placebo-controlled, double-blind Phase I single ascending oral dose study (1 - 150 mg) was conducted, including 56 healthy subjects. Both studies assessed the safety and tolerability, as well as the PK properties of ACD856 after single dose intravenous and oral administration.

resultsACD856 was well tolerated with no treatment emergent, or dose related adverse events or other safety assessments. In the microdose study, ACD856 exhibited a bi-exponential plasma decline, low distribution volume, low plasma clearance with a half-life of approximately 20 hours. Orally, ACD856 exhibited rapid absorption, an almost complete bioavailability and a dose proportional increase in exposure. While the C

conclusionThe prediction proved accurate demonstrating the value of conducting a microdose study prior to ascending dose studies.

trial registrationNCT05783830 March 24, 2023 (microdose study, retrospectively registered) and NCT05077631 October 14, 2021 (single ascending dose study).

Indexed as

Healthy VolunteersAdministration, OralArea Under CurveBiological AvailabilityDose-Response Relationship, DrugDouble-Blind MethodHalf-LifeHumansMaleACD856Alzheimer’s diseaseFirst in HumanNeurotrophinSingle ascending doses

Identifiers

PMID38353689
PMCPMC11001683
OpenAlexW4391814529

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.