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STP1 for Autism Spectrum Disorder

Phase 1
Waitlist Available
Led By Craig Erickson, MD
Research Sponsored by Stalicla SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 7, day 14, day 15 (and optionally: day 16, day 17 and day 18)

Summary

This trial is testing a new medicine called STP1 to see if it is safe and effective for people with Autism Spectrum Disorder (ASD). Researchers will study how the body processes STP1 and its effects on ASD symptoms.

Eligible Conditions
  • Autism Spectrum Disorder
  • Autism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 7, day 14, day 15 (and optionally: day 16, day 17 and day 18)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 7, day 14, day 15 (and optionally: day 16, day 17 and day 18) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and Tolerability
Secondary study objectives
Plasma concentration of STP1 (PK)
Other study objectives
ABC-C: Aberrant Behavior Checklist-Community
CGI-S: Clinical Global Impressions-Severity reflected by the Clinical Global Impressions-Improvement (CGI-I) scale
CSHQ: Children Sleep Habit Questionnaire
+7 more

Side effects data

From 2022 Phase 1 trial • 12 Patients • NCT04644003
33%
Infection
33%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
STP1 High Dose
STP1 Low Dose
Placebo

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: STP1 Low DoseExperimental Treatment1 Intervention
1 capsule and 1 tablet per intake
Group II: STP1 High DoseExperimental Treatment1 Intervention
1 capsule and 1 tablet per intake
Group III: PlaceboPlacebo Group1 Intervention
1 placebo capsule and 1 placebo tablet per intake
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
STP1
2020
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Stalicla SALead Sponsor
4 Previous Clinical Trials
1,756 Total Patients Enrolled
3 Trials studying Autism Spectrum Disorder
1,736 Patients Enrolled for Autism Spectrum Disorder
Craig Erickson, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
5 Previous Clinical Trials
151 Total Patients Enrolled
~2 spots leftby Dec 2025
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