Active not recruitingPhase 1

Phase 1 Study of OLX-07010 in Healthy Adult and Elderly Participants

Phase 1 Randomized, Double-Blind, Single Ascending Dose, Multiple Ascending Dose, and Food Effect Study of the Safety, Tolerability, and Pharmacokinetics of OLX-07010 in Healthy Adult and Elderly Participants

Lead sponsor

Oligomerix, Inc

Asset

OLX-07010

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Age 18-75

Primary endpoint

•Treatment-Emergent 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

NCT IDNCT05696483

Org study IDOLX-07010-01

Timeline

Milestones

Study start2023-01-20actual

Study first posted2023-01-25actual

Last update posted2026-05-22actual

Primary completion2026-06-02estimated

Study completion2026-07-01estimated

Assets

Drug assets

OLX-07010

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Participant voluntarily agrees to participate and signs an approved informed consent prior to performing any of the Screening Visit procedures.

•Participant must be a healthy male or female of non-childbearing potential 18 to 50 years old inclusive, in Part 1, 2, and 4 of the study. Participant must be a healthy elderly male or female of non-childbearing potential 51-75 years old inclusive in Part 3 of the study.

•Male participants with body weight ≥ 55 kg; and females with body weight ≥ 50 kg and body mass index (BMI) between 18 and 30 kg/m2 (inclusive) for Part 1, 2, and 4 of the study; and BMI between 18 and 32 kg/m2 (inclusive) for Part 3 of the study.

•Female participants must be of non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or postmenopausal ≥ 1 year with follicle -stimulating hormone [FSH] > 40 IU/L at screening)

Exclusion criteria

•Participant has clinically significant history or evidence of cardiovascular (CV), respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s).

•Participant has any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs.

•Participant has a history of hypersensitivity to the study drug or any of the excipients or to medicinal products with similar chemical structures.

•Treatment with any investigational drug within the past 30 days prior to dosing.

•Use of any prescription drugs, herbal supplements, within 30 days prior to initial dosing, and over the counter (OTC) medication, dietary supplements (vitamins included) within 2 weeks prior to initial dosing. For elderly population in Part 3, allowed medications must be stable for at least 1 month.

•Clinically significant vital signs or ECG abnormality at screening and at baseline.

•Score of "yes" on specific items of the Suicidal Ideation section of the C-SSRS at the Screening Visit.

•History of any cancer within 5 years of screening (more than 10 years in remission).

•Any history of renal injury/kidney disease or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or blood urea nitrogen (BUN) values in blood, or clinically relevant abnormal urinary constituents at Screening or Admission.

•Participant has any of the liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [ALP], gamma glutamyl transferase [GGT]) or total bilirubin [TBL]) greater than the upper limit of normal (ULN), with the exception of isolated TBL elevation consistent with Gilbert's disease.

•Participants taking medications that are sensitive substrates for CYPC8, CYP2C19, CYP3A4, CYP1A2, and CYP2C9.

•Participant has a significant history of hypersensitivities or allergies to any medications, as determined by the PI/designee.

•Sexually active males not willing to use a condom during intercourse while taking the study drug and until EOS visit.

•Women of childbearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant.

•Female participants are breastfeeding or female participants with a positive serum pregnancy test at the screening visit or positive urine pregnancy test at admission.

•Participants has poor venous access.

•Participant has history of alcohol and/or illicit drug abuse within 12 months prior dosing or positive alcohol/illicit drug test at screening and/or admission; smoking history (use of tobacco products in the previous 3 months prior dosing) or positive cotinine test at screening or admission.

•Participant has donated blood (> 500 mL) or blood products within 2 months prior to admission (Day -1). Plasma donation (> 200 mL) within 7 days prior to first dosing.

•Participant has previously been enrolled in this clinical study.

•Participant has a positive reverse transcription polymerase chain reaction (RT PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

•Participant has clinical signs and symptoms consistent with SARS-CoV-2 infection, e.g., fever, dry cough, dyspnea, sore throat, fatigue, or laboratory confirmed acute infection with SARS-CoV-2.

•Participant who had a severe course of COVID-19; (extracorporeal membrane oxygenation, mechanically ventilated, or Intensive Care Unit stay).

Endpoints (9)

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

8 endpoints

Primary/protocol endpoint

Incidence of Treatment-Emergent Adverse Events as Measured by NCI-CTCAE criteria

Time frame:After each dose of OLX-07010 through completion of dosing, up to 30 days

event count, event

Primary/protocol endpoint

Incidence of Treatment-Emergent Adverse Events as Measured by Clinical Laboratory Measurements According to Established Clinical Normal Ranges

Time frame:Change from baseline at 2-4 hours post-dose of OLX-07010

event count, event

Primary/protocol endpoint

Incidence of Treatment-Emergent Adverse Events as Measured by ECG

Time frame:Change from baseline at 2, 4, and 8 hours and Days 2 and 4 post-dose of OLX-07010

event count, event

Primary/protocol endpoint

Incidence of Treatment-Emergent Adverse Events as Measured by Neurological Examination

Time frame:Change from baseline at Day 1, Day 4 (Parts 1 and 3) and Days 7 and 10 (Parts 2 and 4) post-dose of OLX-07010

event count, event

Secondary/protocol endpoint

Maximum drug concentration in plasma (Cmax) of OLX-07010 after single ascending doses

Time frame:Blood collection on Day 1, 2, 3, and 4. On Day 1 (pre-dose 0 hour, post-dose at 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, 7, 9, and 12 hours), Day 2 (24 hours post-dose), Day 3 (48 hours post-dose) and Day 4 (72 hours post-dose).

concentration, descriptive

Secondary/protocol endpoint

Maximum drug concentration in plasma (Cmax) of OLX-07010 after multiple ascending doses

Time frame:Day 1and Day 7 (pre-dose 0 hour, and post-dose at 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, 7, 9, 12 hours), Days 2 (24 hours post-dose) to Day 6 (pre-dose 0 hours), Day (24 hours post-dose), Day 9 (48 hours post-dose), and Day 10 (72 hours post-dose).

concentration, descriptive

Secondary/protocol endpoint

Area under the concentration-time curve in plasma (AUC) of OLX-07010 after single ascending doses.

Time frame:Blood collection on Day 1, 2, 3, and 4. On Day 1 (pre dose 0 hour, post-dose at 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, 7, 9, and 12 hours), Day 2 (24 hours post-dose), Day 3 (48 hours post-dose) and Day 4 (72 hours post-dose).

concentration, descriptive

Secondary/protocol endpoint

Area under the concentration-time curve in plasma (AUC) of OLX-07010 after multiple ascending doses.

concentration, descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Renal clearance and percent drug excreted in Urine after single and multiple ascending doses of OLX-07010.

Time frame:Part 1:Day 1 at 0 hour (pre-dose), 0-4; 4-8; 8-12; and 12-24 hours post-dose. Part 2: Day 1 and Day 7 at 0 hour (pre-dose), 0-4 hours; 4-8 hours; 8-12 hours; 12-24 hours.

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.