---
title: Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of ACD856
nct_id: NCT05077501
overall_status: COMPLETED
phase: PHASE1
sponsor: AlzeCure Pharma
study_type: INTERVENTIONAL
primary_condition: Alzheimer Disease
countries: Sweden
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05077501.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05077501"
ct_last_update_post_date: 2022-07-20
last_seen_at: "2026-05-12T06:29:31.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of ACD856

**Official Title:** A Prospective, Phase I, Double-blind, Parallel-group, Placebo-controlled, Randomised Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of ACD856 in Healthy Volunteers

**NCT ID:** [NCT05077501](https://clinicaltrials.gov/study/NCT05077501)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 24
- **Lead Sponsor:** AlzeCure Pharma
- **Conditions:** Alzheimer Disease, Cognition Disorder
- **Start Date:** 2021-09-29
- **Completion Date:** 2022-05-23
- **CT.gov Last Update:** 2022-07-20

## Brief 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Signed and dated informed consent prior to any study-mandated procedure.
* Willing and able to comply with study requirements.
* Healthy male or female adults of non-childbearing potential aged ≥ 18 and ≤ 65 years at screening.
* Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 at screening.
* Only subjects of non-childbearing potential may be included in the study. Male subjects with partners of childbearing potential must be willing to use condoms, be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a partner, as well as refrain from donating sperm from the date of dosing until 3 months after dosing with the IMP.
* Clinically acceptable medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.

Exclusion Criteria:

* Any exposure to ACD856 in the past.
* Treatment with another investigational drug within 3 months prior to or during the study.
* Positive screen for drugs of abuse or a positive alcohol result at screening or admission to the clinic.
* Clinically relevant findings in laboratory parameters, ECG or vital signs at screening.
* Current smokers or subjects who use nicotine products.
* History of alcohol abuse or excessive intake of alcohol.
* History of, or current use of, anabolic steroids.
* Excessive caffeine consumption.
* Plasma donation or blood donation prior to screening.
* Any planned night shift work within the duration of the study, from 48 h prior to randomisation until follow-up.
* Any planned major surgery within the duration of the study.
* Evidence of an active infection that requires treatment with antibiotics within 2 weeks of planned dosing.
```

## Arms

- **ACD856** (EXPERIMENTAL)
- **Placebo** (PLACEBO_COMPARATOR)

## Interventions

- **ACD856** (DRUG) — 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.
- **Placebo** (DRUG) — Placebo oral solution

## Primary Outcomes

- **Frequency of adverse events (AEs)** _(time frame: 16 days)_ — Number and percentage of subjects with adverse events (AEs).
- **Clinically significant changes in 12-lead ECGs** _(time frame: 16 days)_ — Number of subjects and percentage of subjects with clinically significant changes in 12-lead ECGs
- **Clinically significant changes in vital signs** _(time frame: 16 days)_ — Number of subjects and percentage of subjects with clinically significant changes in vital signs or stool frequency
- **Clinically significant changes in hematology, clinical chemistry, coagulation and/or urinalysis parameters** _(time frame: 16 days)_ — Number of subjects and percentage of subjects with clinically significant changes in any safety laboratory assessments.
- **Clinically significant changes in physical examinations** _(time frame: 16 days)_ — Number of subjects and percentage of subjects with clinically significant changes in physical examinations
- **GAD-7** _(time frame: 16 days)_ — Change from baseline of GAD-7
- **PHQ-9** _(time frame: 16 days)_ — Change from baseline of PHQ-9
- **C-SSRS** _(time frame: 16 days)_ — Change from baseline of C-SSRS
- **Prolactin** _(time frame: 10 days)_ — Change from baseline of prolactin levels

## Locations (1)

- Uppsala University Hospital, Uppsala, Sweden

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.uppsala university hospital|uppsala||sweden` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05077501.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05077501*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*