CompletedPhase 1

MAD Phase I Study to Investigate Contraloid Acetate

Single-center, Randomized, Prospective, Double-blind, Placebo Controlled Phase Ib Study With an Adaptive Multiple Ascending Dose (MAD) Design to Investigate the Safety, Tolerability, Pharmacokinetics of Contraloid Acetate (Healthy Subjects)

Lead sponsor

Prof. Dr. Dieter Willbold

Asset

Contraloid

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 18-45

Primary endpoints

•Assessment of safety and tolerability of Contraloid by monitoring vital signs•Assessment of pharmacokinetics of Contraloid•AUC0-24 of Contraloid does not exceed of 2.3 µg·h/mL

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDEUDRA-CT: 2018-002500-14

NCT IDNCT03955380

Timeline

Milestones

Study start2018-12-12actual

Primary completion2019-04-03actual

Study completion2019-04-03actual

Study first posted2019-05-20actual

Last update posted2019-05-20actual

Assets

Drug assets

Contraloid

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Male and female subjects willing and able to give their written consent to participate in the trial after having received information about the study design, the objectives of the project, the possible derivative risks, and their right to withdraw from the study at any time and for any reason.

•Healthy male and female subjects aged within: 18 to 45 years (limits included).

•With clinical history and physical examination results within normality.

•Electrocardiogram without clinically significant pathologic abnormalities and with QTc values lesser than 450 ms.

•Normotensive as defined by Systolic Blood Pressure ≤ 150 mm Hg. Diastolic Blood Pressure ≤ 90 mm Hg.

•BMI between 19.0 and 30.0 kg/m2.

•Body weight between 55 and 85 kg, inclusive.

•Women who were neither pregnant (negative urine pregnancy test) nor nursing and who were either:

•Surgically sterile (bilateral tubal ligation, hysterectomy)

Exclusion criteria

•Any chronic medical condition (such as type 1 diabetes) requiring chronic treatment that might increase the risk to the subject or confound the interpretation of safety observations.

•Evidence of active infection requiring antibiotic therapy within 14 days prior to screening.

•Medical history of vasculitis or any autoimmune disease excluding seasonal allergic rhinitis and childhood history of atopic dermatitis.

•History of any treatment for cancer within the past 2 years, other than basal cell or squamous cell carcinoma of the skin.

•Seropositive for human immunodeficiency virus (HIV).

•History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for Hepatitis B surface antigen [HbsAg] or anti-Hepatitis C [HCV] antibody).

•Clinically significant abnormalities in screening laboratory tests, including:

-Absolute neutrophil count < 1.4 x109

-Alanine transaminase (ALT) or aspartate transaminase (AST) > 1.5 x the upper limit of normal (ULN)

-Absolute lymphocyte count < 1.2 x 109

-Lactate dehydrogenase (LDH) > 1.5 x ULN

-Total bilirubin level: Out of normal range 0-1.5 mg/dL

-eGFR < 60 mL/min

-Hemoglobin (Hgb): out of normal range (male: 13,5-18,0 g/dL, female: 12,0 - 16,0 g/dL)

-CK level higher than 250U/L

•All prescription, over-the-counter and herbal medications are prohibited within 10 days prior to study dosing (with exception of calcium/vitamin D supplements, nasal steroids, ocular medications, and paracetamol ≤1000 mg/day at the discretion of the Investigator).

•Use of an investigational drug within 2 months prior to dosing in this study.

•Any disorder that could interfere with the absorption, distribution, metabolism or excretion of drugs (e.g. small bowel disease, Crohn's disease, celiac disease, or liver disease.)

•Psychiatric history of current or past psychosis, bi-polar disorder, clinical depression, or anxiety disorder requiring chronic medication within the past 5 years.

•History of substance abuse, including alcohol

•Smokers

•History of substance or drug dependence, or positive urine drug screen at screening visit.

•History of head injury.

•Chronic kidney disease (defined as the presence of any degree of proteinuria on urine analysis and/or an eGFR of <60 ml/min using the MDRD formula).

•Any reason or opinion of the investigator that would prevent the subject from participation in the study.

•Inability to follow the instructions or an unwillingness to collaborate during the study.

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

9 endpoints

Primary/protocol endpoint

Assessment of safety and tolerability of Contraloid by monitoring vital signs, ECG and lab values

Time frame:21 days for cohort 1 and 35 days for cohort 2

event count, event

Primary/protocol endpoint

Assessment of pharmacokinetics of Contraloid: Area under curve (AUC) in plasma

Time frame:168 hours

concentration, descriptive

Primary/protocol endpoint

Assessment of pharmacokinetics of Contraloid: Cmax in plasma

Time frame:21/35 days

concentration, descriptive

Primary/protocol endpoint

Assessment of pharmacokinetics of Contraloid: Tmax in plasma

Time frame:21/35 days

concentration, descriptive

Primary/protocol endpoint

Assessment of pharmacokinetics of Contraloid: Terminal elimination half-life (t1/2) in plasma

Time frame:21/35 days

concentration, descriptive

Primary/protocol endpoint

Assessment of pharmacokinetics of Contraloid: distributive half-life (t1/2alpha) in plasma

Time frame:21/35 days

concentration, descriptive

Primary/protocol endpoint

Assessment of pharmacokinetics of Contraloid: terminal elimination half-life (t1/2beta) in plasma

Time frame:21/35 days

concentration, descriptive

Primary/protocol endpoint

Assessment of pharmacokinetics of Contraloid: Elimination Constant (Kel alpha) in plasma

Time frame:21/35 days

descriptive

Primary/protocol endpoint

Assessment of pharmacokinetics of Contraloid: Elimination Constant (Kel beta) in plasma

Time frame:21/35 days

descriptive

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

AUC0-24 of Contraloid does not exceed of 2.3 µg·h/mL

Time frame:21/35 days

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.