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A Phase 1 (First in Human) Randomized, Double-blind, Placebo-controlled SAD, MAD Study With Oral REM0046127

NCT04672135 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2022-05-19

No results posted yet for this study

Summary

This is a phase 1 randomized double blind, first in human (FIH) study with the novel oral Alzheimer drug candidate REM0046127, which consists of two main parts, a single ascending dose (SAD) study with 7 cohorts followed by a multiple ascending dose (MAD) study with 2 cohorts.

Conditions

  • Alzheimer Disease

Interventions

DRUG

REM0046127

Oral solution: 100 mg/mL REM0046127

DRUG

Placebo

Oral solution with 0 mg/mL REM0046127

Sponsors & Collaborators

  • NeuroScios GmbH

    collaborator UNKNOWN

  • reMYND

    lead INDUSTRY

Principal Investigators

  • Nikola Helmberg, PhD · NeuroScios GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-11-09
Primary Completion
2022-04-01
Completion
2022-04-26

Countries

  • Austria

Study Locations

More Related Trials

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 NCT04672135 on ClinicalTrials.gov