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Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of ACD856

NCT05077501 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-07-20

No results posted yet for this study

Summary

The multiple ascending dose (MAD) design of the study is based on the aim to study safety, tolerability, PK and pharmacodynamics 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

Multiple daily oral doses of ACD856 will be administered for 7 days in an escalation scheme of dose 1, dose 2 and dose 3. The escalation schedule may be adapted based on evaluation by the internal Safety Review Committee.

DRUG

Placebo

Placebo oral solution

Sponsors & Collaborators

  • AlzeCure Pharma

    lead INDUSTRY

Principal Investigators

  • Johan Sandin, PhD · AlzeCure Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-09-29
Primary Completion
2022-05-16
Completion
2022-05-23

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 NCT05077501 on ClinicalTrials.gov