Alzheimer DiseasePhase 1NCT05696483
Phase 1 Study of OLX-07010 in Healthy Adult and Elderly Participants
A Phase 1 study testing OLX-07010 Active in people with Alzheimer Disease, run by Oligomerix, Inc at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- OLX-07010 Active
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2023to 1 Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
California Clinical Trials Medical Group, Inc
Glendale, California, 91206
About this study
Official title: 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).
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- OLX-07010 Active, OLX-07010 Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLX-07010 ActiveDrug
25 and 75 mg capsules
OLX-07010 PlaceboDrug
25 and 75 mg capsules
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Active OLX-07010 in single ascending and multiple ascending dose cohorts Receives: Drug: OLX-07010 Active |
| Placebo | Placebo comparator | OLX-07010 placebo in single ascending and multiple ascending dose cohorts Receives: Drug: OLX-07010 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events as Measured by NCI-CTCAE criteria
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)
Measured: 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
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
Measured: Change from baseline at 2-4 hours post-dose of OLX-07010
Incidence of Treatment-Emergent Adverse Events as Measured by ECG
ECGs will be used to measure changes to the heart after administration of OLX-07010
Measured: 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
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
Measured: 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 outcomes (5)
Maximum drug concentration in plasma (Cmax) of OLX-07010 after single ascending doses
The maximum drug concentration will be determined after a single ascending doses
Measured: 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
The maximum drug concentration will be determined after a single ascending doses
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Determine the the renal clearance and amount of OLX-07010 excreted in urine.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start20 Jan 2023
- Primary completion11 May 2026
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Randomized, double-blind, four-part study of single ascending doses and 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oligomerix, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696483
- Sponsor's protocol ID
- OLX-07010-01
- Status last verified
- Jul 2026
- First submitted
- 13 Dec 2022
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05696483
- Acronym / sponsor ID
- OLX-07010-01
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Oligomerix, IncIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, four-part study of single ascending doses and 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.
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: OLX-07010 ActiveActive OLX-07010 in single ascending and multiple ascending dose cohorts |
| Placebo | Placebo comparator | Drug: OLX-07010 PlaceboOLX-07010 placebo in single ascending and multiple ascending dose cohorts |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OLX-07010 Active25 and 75 mg capsules | Drug | Active |
| OLX-07010 Placebo25 and 75 mg capsules | Drug | Placebo |
Primary outcome
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)
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
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
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
5 secondary outcomes
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).
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).
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).
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OLX-07010 Active in people with Alzheimer Disease, run by Oligomerix, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.