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

NCT05696483 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2026-05-22

No results posted yet for this study

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).

Conditions

Interventions

DRUG

OLX-07010 Active

25 and 75 mg capsules

DRUG

OLX-07010 Placebo

25 and 75 mg capsules

Sponsors & Collaborators

  • Oligomerix, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-20
Primary Completion
2026-06-02
Completion
2026-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05696483 on ClinicalTrials.gov