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
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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