At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
STP1 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b, Double-Blind, Placebo-Controlled, First-in-Human Study to Evaluate Safety, Tolerability and Pharmacokinetics of a Two-Week Oral Treatment With STP1 in a Subgroup of Patients With Autism Spectrum Disorder
In Brief
A Phase 1 clinical trial evaluating STP1 and Placebo for Autism Spectrum Disorder. Completed, enrolled 12 participants across 1 site.
Detailed Summary
The main purpose of this study is to evaluate safety and tolerability in a subgroup of patients with Autism Spectrum Disorder (ASD). In addition, Pharmacokinetics and Pharmacodynamics, as well as efficacy of STP1 are being explored.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism Spectrum Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
202120222023202420252026
First PostedNov 2020
Enrollment StartDec 2020
Primary CompletionJan 2022
TodayJul 2026
First PostedNov 25, 2020
Enrollment StartDec 7, 2020
Primary CompletionJan 28, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.6 years ago
Interventions
STP1drug
STP1 is a combination of two drugs, a phosphodiesterase (PDE) inhibitor and an NKCC1 inhibitor
Placebodrug
Placebo medication (capsule and tablet) identical in appearance to active medication