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

July 27, 2026 updated by: Oligomerix, Inc

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

This First-in-human (FIH) study will evaluate the safety, tolerability, and pharmacokinetics of the tau self-association inhibitor, OLX-07010 in single ascending doses (SAD) and multiple ascending doses (MAD) in healthy adults (18-50 of age inclusive), and single dose in healthy elderly (51-75 of age inclusive). The effects of dosing with or without food in healthy adults will also be studied (optional).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This FIH Phase 1 randomized, double-blind, four-part study will be conducted to evaluate the safety, tolerability, and PK of the tau self-association inhibitor, OLX-07010 in single ascending doses, multiple ascending doses in healthy adult participants, and as a single dose in healthy elderly participants. There is an option for an additional part to evaluate the effects of food (fed and fasted) on OLX-07010 in healthy adult participants. This study will be divided into 4 parts: Part 1-Randomized Double-Blind Single Ascending Dose in Healthy Adult Participants; Part 2-Randomized Double-Blind Multiple Ascending Dose in Healthy Adults Participants; Part 3-Randomized Double-Blind Single Dose in Healthy Elderly Participants; and Part 4 (Optional)-Food Effect (Single Cohort, 2 Sequence, 2 Period Crossover Fed and Fasted) in Healthy Adult Participants.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91206
        • California Clinical Trials Medical Group, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active
Active OLX-07010 in single ascending and multiple ascending dose cohorts
Drug: OLX-07010 Active
25 and 75 mg capsules
Placebo Comparator: Placebo
OLX-07010 placebo in single ascending and multiple ascending dose cohorts
Drug: OLX-07010 Placebo
25 and 75 mg capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Safety and tolerability of OLX-07010 will be assessed by documenting adverse events occurring after single dose administration (Parts 1, 3 and 4) and multiple dose administration (Part 2)
After each dose of OLX-07010 through completion of dosing, up to 30 days
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
Blood and Urine samples will be taken after administration of OLX-07010 and values will be compared to baseline and established normal ranges to determine how OLX-07010 administration impacts normal body function
Change from baseline at 2-4 hours post-dose of OLX-07010
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
ECGs will be used to measure changes to the heart after administration of OLX-07010
Change from baseline at 2, 4, and 8 hours and Days 2 and 4 post-dose of OLX-07010
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
Neurological assessments will be performed to investigate the potential effect of the study drug on mental status, gait (normal/abnormal), coordination/incoordination, tremor, muscle tone, stereotypy and biceps reflexes
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
The maximum drug concentration will be determined after a single ascending doses
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).
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).
The maximum drug concentration will be determined after a single ascending doses
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).
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).
Determine the Area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration (tlast) and from pre-dose (time 0) extrapolated to infinite time (AUClast + Clast/λz) calculated using the linear-log trapezoidal rule.
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).
Area under the concentration-time curve in plasma (AUC) 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).
Determine the Area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration (tlast) and from pre-dose (time 0) extrapolated to infinite time (AUClast + Clast/λz) calculated using the linear-log trapezoidal rule.
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).
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.
Determine the the renal clearance and amount of OLX-07010 excreted in urine.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oligomerix, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 11, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OLX-07010-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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