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Safety, Tolerability, and Pharmacokinetics (PK) of Single and Multiple Ascending Oral Doses of iQ-007

NCT06899230 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-12-29

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled study conducted in healthy adult volunteers to assess the safety, tolerability and pharmacokinetics of iQ-007. iQ-007 may be indicated for use in patients with Focal Seizures and Drug-resistant Epilepsy (DRE).

Conditions

  • Drug Resistant Epilepsy
  • Focal Seizure

Interventions

DRUG

iQ-007

Highly selective, orally bioavailable, positive allosteric modulator (PAM) of the excitatory amino acid transporter-2 (EAAT2) and its rodent homologue (glutamate transporter-1\[GLT-1).

DRUG

Placebo

Oral capsules identical in appearance to drug and containing vehicle only (Gelucire/Capmul-M).

Sponsors & Collaborators

  • Avance Clinical Pty Ltd.

    collaborator INDUSTRY

  • iQure Australia Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Henk de Wilde · iQure Australia Pty Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2025-04-08
Primary Completion
2026-01-29
Completion
2026-01-29

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

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 NCT06899230 on ClinicalTrials.gov