CT01

CompletedPhase 1

Safety, Pharmacokinetics and Pharmacodynamics Study of Treatment With CHF 5074 in Healthy Young Male Subjects

Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of CHF 5074 in Healthy Young Male Subjects

Lead sponsor

CERESPIR

Asset

CHF 5074

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Age 18-45•Male

Primary endpoint

•Adverse Events

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 IDCCD-0814-PR-0008

NCT IDNCT00954252

Timeline

Milestones

Study first posted2009-08-07estimated

Study start2009-10 (month precision)

Primary completion2010-05actual (month precision)

Study completion2010-05actual (month precision)

Last update posted2015-02-10estimated

Assets

Drug assets

CHF 5074

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•Subject's written informed consent is obtained prior to any study-related procedures.

•Subject is nonsmoking male between 18 and 45 years of age, inclusive.

•Subject has a body mass index between 18 and 30 kg/m2, inclusive.

•Subject is judged, by the investigator, to be in good health on the basis of medical history, complete physical examination including vital signs, 12-lead electrocardiogram (ECG) and standard laboratory tests including complete hematology, blood chemistry (glucose, creatinine, blood urea nitrogen, alanine aminotransferase, aspartate aminotransferase, albumin, alkaline phosphatase, sodium, potassium), thyroid function, urinalysis (glucose, hemoglobin, blood, proteins, pH) and fecal occult blood.

•Subject understands the procedures and agrees to participate in the study program

Exclusion criteria

•Subject is mentally or legally incapacitated.

•Subject has a history of any illness that, in the opinion of the investigator and according to the protocol, might confound the results of the study or pose additional risk in administering CHF5074 to the subject.

•Subject has a medical history (within the last 10 years) of major cardiovascular, hepatic or renal disease.

•Subject has liver function test abnormalities with elevated AST or ALT greater than or equal to 2 times upper limit of normal and/or elevated bilirubin greater than or equal to 2 times upper limit of normal.

•Subject has renal function test abnormalities, including serum creatinine greater than 1.8 g/dL.

•Subject has abnormal fasting serum concentrations of TSH, T3 or T4.

•Subject has a positive result for fecal occult blood testing performed at screening.

•Subject has clinically significant abnormalities on physical examination, ECG or laboratory tests carried out at screening.

•Subject has a history of a psychiatric disorder.

•Subject has significant allergic conditions that require medical treatment or has known hypersensitivity to medications that could be activated by CHF5074 treatment.

•Subject is positive on testing for hepatitis B surface antigen, hepatitis C antibody or HIV 1 or 2 antibodies.

•Subject has donated blood within the 1 month prior to screening.

•Subject has a history of alcohol or drug abuse in the past 12 months.

•Subject used any psychoactive, recreational or prescription drug within the 4 weeks prior to study drug administration.

•Subject has used ibuprofen, sulindac sulfide, indomethacin, flurbiprofen within 2 weeks prior to study drug administration.

•Subject has used any other over-the-counter drug within 1 week prior to study drug administration Occasional treatment with acetaminophen or aspirin is permitted but must be reported to the investigator. Vitamins are permitted.

•Subject is positive on urine drug screening for drugs of abuse (cannabinoids, cocaine, opiates, amphetamines, barbiturates, benzodiazepines).

•Subject has evidence of alcohol on screening blood work and breathalyzer test.

•Subject does not agree to use a medically acceptable contraceptive (abstain from sexual intercourse, or use a condom with spermicide) for 7 days after study drug administration, or has not had a vasectomy at least 6 months prior to study participation.

•Subject is unlikely to comply with the study protocol or unable to understand the nature and scope of the study or the possible benefits or unwanted effects of the study treatments.

•Subject has participated in another investigational study within 30 days prior to screening.

Endpoints (2)

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.

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Adverse Events

Time frame:from Screening through Day +3

event count, event

Secondary/protocol endpoint

Dose linearity of CHF5074 plasma levels (Cmax and AUC0-t)

Time frame:Day -1 through Day +3

concentration, descriptive

Publications (16)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.