NCT05027451

Safety, Tolerability, and Pharmacokinetics of IXT-m200

A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single-Dose Intravenous Study to Evaluate the Safety and Pharmacokinetics of IXT-m200 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: InterveXion Therapeutics, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Approximately 9 participants will be enrolled in the study in a single cohort. Participants will be randomized to 3 g IXT-m200 or placebo at 7:2. Each will receive their dose as a 30-min intravenous infusion, then remain at the study site overnight to complete Day 1 and Day 2 assessments (e.g., electrocardiogram (ECG), laboratory assessments, blood draws, and vital signs). Following discharge on Day 2, participants will return to the clinic for follow-up pharmacokinetic (PK) and safety assessments on Day 8, then every 1-3 weeks thereafter until Day 127.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	IXT-m200	Anti-methamphetamine chimeric monoclonal antibody (mAb)
OTHER	Placebo	Normal saline

Timeline

• Start date: 2021-10-25
• Primary completion: 2022-03-18
• Completion: 2022-03-18
• First posted: 2021-08-30
• Last updated: 2023-06-01
• Results posted: 2023-06-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study