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Study to Evaluate the Effects of Single Ascending Oral Doses of ACD856 on Safety, Tolerability and Pharmacokinetics

NCT05077631 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-07-20

No results posted yet for this study

Summary

The SAD design of the study is based on the aim to study safety, tolerability and PK of selected doses of ACD856 in a limited number of healthy volunteers. ACD856 will be administered orally.

Conditions

  • Alzheimer Disease
  • Cognition Disorder

Interventions

DRUG

ACD856

Single oral doses of ACD856 administered in a fasted state in escalation schedule of dose 1, dose 2, dose 3, dose 4, dose 5, dose 6 and dose 7. The escalation schedule may be adapted based on evaluation by internal Safety Review Committee.

DRUG

Placebo

Placebo oral solution

DRUG

ACD856 (fed cohort)

Single oral dose of ACD856 in fed state of either dose 4 or dose 5.

Sponsors & Collaborators

  • AlzeCure Pharma

    lead INDUSTRY

Principal Investigators

  • Johan Sandin · AlzeCure Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-15
Primary Completion
2022-02-22
Completion
2022-02-22

Countries

  • Sweden

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05077631 on ClinicalTrials.gov