# Therapeutic Agent for Rapid Reversal of Methamphetamine Intoxication

> **NIH NIH U01** · CLEAR SCIENTIFIC, LLC · 2022 · $4,067,228

## Abstract

PROJECT SUMMARY
This effort addresses the urgent need for a safe rapidly acting reversal agent for
methamphetamine. Methamphetamine (meth) is the fastest growing drug of abuse in the US and has become
a significant burden on the health care system, accounting for over 200,000 emergency room visits and nearly
10,000 deaths annually. As yet, no current therapeutics are available to treat meth intoxication. The long-term
objective is to obtain FDA approval for sale and marketing of CS-1103, a small-molecule sequestrant, for
treatment of acute meth intoxication. CS-1103 selectively binds meth in blood and dramatically accelerates its
removal from the body by clearance into the urine, representing a new approach to reversal of drug effect:
remove the cause and remove the effect. CS-1103 was well-tolerated and provided rapid long-lasting
reversal of acute meth intoxication in pilot pre-clinical studies in rodent and non-human primate (NHP).
It is proposed here to complete all necessary preclinical studies and Chemistry, Manufacturing and Controls
(CMC) requirements to obtain Investigational New Drug (IND) approval from the FDA and then complete the
first-in-human Phase I clinical trial for CS-1103. These significant milestones on the path to FDA approval will
be achieved via completion of the following Aims: Aim 1 will establish a chemical process to
manufacture CS-1103 under Current Good Manufacturing Practices (cGMP). A batch of cGMP
material will be produced for pre-clinical and clinical trials. An injectable formulation will be developed and
characterized. Aim 2 will establish the safety and efficacy profile of CS-1103 for reversal of
methamphetamine intoxication in pre-clinical IND-enabling studies. Standard toxicology,
pharmacokinetics, and pharmacodynamics studies will be conducted per FDA requirements. A detailed dose-
ranging study in NHP will be performed to establish a safe initial human dose; the end-point will be the
maximum safe/well tolerated dose. A pre-IND meeting will be held with FDA to set protocols and requirements.
Aim 3 will establish a protocol for the first-in-human Phase I clinical trial of CS-1103. The protocol
will include: estimate of number of subjects; description of safety exclusions and inclusion criteria; description
of dosing plan including duration, dose, dose escalation, and schedule; all details critical to safety; dosing
escalation rules and stopping criteria; and discussion of rationale for intended dose, duration, schedule, and
route of administration. Expected outcome is filing of complete IND package with FDA. Aim 4 will establish
the safety and dose level of CS-1103 in an FDA Phase I trial. This study will be conducted on healthy,
drug-naive volunteers. Expected outcome is that CS-1103 will be safe at doses anticipated to be effective for
reversal of acute methamphetamine intoxication.

## Key facts

- **NIH application ID:** 10425422
- **Project number:** 5U01DA053054-03
- **Recipient organization:** CLEAR SCIENTIFIC, LLC
- **Principal Investigator:** Xinhua Li
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $4,067,228
- **Award type:** 5
- **Project period:** 2020-09-30 → 2024-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10425422

## Citation

> US National Institutes of Health, RePORTER application 10425422, Therapeutic Agent for Rapid Reversal of Methamphetamine Intoxication (5U01DA053054-03). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10425422. Licensed CC0.

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