Phase 1
Completed N=32
A Clinical Study to Evaluate the Safety of CS-1103 in Healthy Participants
Substance Use Disorders · Methamphetamine Abuse · Methamphetamine Intoxication
Source: ClinicalTrials.gov NCT06316973 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (AEs) — 1; 1; 2; 4 Participants
Summary
The purpose of this Phase 1a study is to evaluate safety, tolerability, and pharmacokinetics (PK) of single, ascending doses of CS-1103, administered by intravenous (IV) infusion in healthy participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) |
1; 1; 2; 4; 0; 0 | — |
| PRIMARY Number of Participants by Severity of AEs |
1; 1; 2; 4; 0; 0 | — |
| SECONDARY Plasma Pharmacokinetic (PK) Parameter: Cmax |
20.78; 58.25; 156.9; 176.0 | — |
| SECONDARY Plasma PK Parameter: Tmax |
0.235; 0.180; 0.180; 0.180 | — |
| SECONDARY Plasma PK Parameter: t1/2 |
4.323; 4.118; 4.215; 4.558 | — |
| SECONDARY Plasma PK Parameter: CL |
0.04915; 0.04971; 0.04762; 0.05040 | — |
| SECONDARY Plasma PK Parameter: Vz |
0.3065; 0.2953; 0.2896; 0.3273 | — |
| SECONDARY Urine PK Parameter: Fe (0-last) |
91.58; 108.3; 101.0; 98.70 | — |
Eligibility Criteria
Major Inclusion Criteria:
- Healthy male and/or female participants aged 18 to 55 years, inclusive.
- A body mass index between 18.0 to 30.0 kg/m2, inclusive, and a minimum body weight of 50 kg.
- Females must be of nonchildbearing potential.
Major Exclusion Criteria:
- Estimated glomerular filtration rate <90 mL/min/1.73 m2
- Any clinically significant abnormalities in rhythm, conduction or morphology of the resting ECG, and any clinically important abnormalities in the 12-lead ECG
- Current smokers, or those who have smoked or used nicotine products (including nicotine patches) within 1 month prior to dose administration.
- History of alcohol abuse or excessive intake of alcohol
Data sourced from ClinicalTrials.gov (NCT06316973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.