OLX-07010 for Alzheimer's Disease Prevention

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Oligomerix, Inc

Must not be taking: Prescription drugs, Herbal supplements

Disqualifiers: Cardiovascular, Respiratory, Hepatic, others

Compensation: Varies

Number of Visits: 6

88 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

Healthy adults aged 18-50 and healthy elderly individuals aged 51-75, all of non-childbearing potential, can participate. They must have a stable weight within certain BMI ranges and no significant medical history or current conditions that could affect the study drug's processing in the body.

Inclusion Criteria

I am between 51-75 years old and cannot have children, participating in Part 3 of the study.

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

I am a man weighing at least 55 kg or a woman weighing at least 50 kg with a BMI of 18-30 for most parts of the study, and 18-32 for part 3.

Exclusion Criteria

I am showing signs of or have tested positive for COVID-19.

I have difficulty with blood draws or IV access due to poor veins.

Participant has previously been enrolled in this clinical study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive single ascending doses of OLX-07010 to evaluate safety, tolerability, and pharmacokinetics

1 week

Multiple visits over 4 days for blood collection and monitoring

Multiple Ascending Dose (MAD)

Participants receive multiple ascending doses of OLX-07010 to evaluate safety, tolerability, and pharmacokinetics

2 weeks

Daily visits for dosing and monitoring, with additional follow-up visits

Food Effect Study (Optional)

Participants receive OLX-07010 with and without food to evaluate the effect of food on drug pharmacokinetics

1 week

2 periods of dosing with crossover design

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• OLX-07010

Trial Overview The trial is testing OLX-07010, a new medication aimed at inhibiting tau protein association which is implicated in Alzheimer's disease. It will be given in varying doses to see how safe it is and how it behaves inside the body when taken alone or with food.

Participant Groups

Group I: Active Experimental Treatment 1 Intervention

Active OLX-07010 in single ascending and multiple ascending dose cohorts

Group II: Placebo Placebo Group 1 Intervention

OLX-07010 placebo in single ascending and multiple ascending dose cohorts

Who Is Running the Clinical Trial?

Oligomerix, Inc

Lead Sponsor

Trials

1

Recruited

90+