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Phase 1 Study of OLX-07010 in Healthy Adult and Elderly Participants | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATIONPHASE1

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

NCT05696483•Oligomerix, Inc

View on ClinicalTrials.gov

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). 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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

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.
+12 more criteria

Locations (1)

California Clinical Trials Medical Group, Inc

Glendale, California, United States

Key Dates

Start Date

January 20, 2023

Primary Completion Date

January 2, 2026

Completion Date

February 1, 2026

Last Updated

May 18, 2025

Enrollment

ESTIMATED participants

Conditions

Alzheimer Disease

Interventions

OLX-07010 Active

DRUG

OLX-07010 Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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