Trial · NCT04644003

Safety, Tolerability and Pharmacokinetics Study of STP1 in a Subgroup of Patients With Autism Spectrum Disorder (ASD)

NCT04644003, Phase 1, Completed, Stalicla SA; results first posted 2024-11-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety, Tolerability and Pharmacokinetics Study of STP1 in a Subgroup of Patients With Autism Spectrum Disorder (ASD). Trials, record NCT04644003. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04644003

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety, Tolerability and Pharmacokinetics Study of STP1 in a Subgroup of Patients With Autism Spectrum Disorder (ASD)
NCT number: NCT04644003
Status: Completed
Phases: Phase 1
Enrollment: 12 participants, actual
Lead sponsor: Stalicla SA
Conditions: Autism Spectrum Disorder
Interventions: STP1, Placebo
First posted: 2020-11-25
Last updated: 2024-11-08
Results first posted: 2024-11-08

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Safety and Tolerability	14 days	Number of Participants with Adverse Events (nature and frequency of non-serious adverse events, serious adverse events and adverse events of special interest).

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Safety and Tolerability	14 days	All patients receiving at least 1 dose of randomised treatment.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Safety and Tolerability	STP1 Low Dose	6	Participants
Safety and Tolerability	STP1 High Dose	3	Participants
Safety and Tolerability	Placebo	3	Participants

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	STP1 Low Dose	6
Overall Study	STARTED	STP1 High Dose	3
Overall Study	STARTED	Placebo	3
Overall Study	COMPLETED	STP1 Low Dose	6
Overall Study	COMPLETED	STP1 High Dose	3
Overall Study	COMPLETED	Placebo	3
Overall Study	NOT COMPLETED	STP1 Low Dose	0
Overall Study	NOT COMPLETED	STP1 High Dose	0
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events21

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhoea	Gastrointestinal disorders	STP1 Low Dose	1	6	1
other	Diarrhoea	Gastrointestinal disorders	STP1 High Dose	0	3	0
other	Diarrhoea	Gastrointestinal disorders	Placebo	0	3	0
other	Nausea	Gastrointestinal disorders	STP1 Low Dose	1	6	1
other	Nausea	Gastrointestinal disorders	STP1 High Dose	0	3	0
other	Nausea	Gastrointestinal disorders	Placebo	2	3	2
other	Infection	Infections and infestations	STP1 Low Dose	0	6	0
other	Infection	Infections and infestations	STP1 High Dose	1	3	1
other	Infection	Infections and infestations	Placebo	0	3	0
other	Upper respiratory tract infection	Infections and infestations	STP1 Low Dose	0	6	0

1 to 10 of 21Source ClinicalTrials.gov

See all 21 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	STP1 Low Dose	0	6
Total, all-cause mortality	STP1 High Dose	0	3
Total, all-cause mortality	Placebo	0	3
Total, other adverse events	STP1 Low Dose	5	6
Total, other adverse events	STP1 High Dose	2	3
Total, other adverse events	Placebo	2	3
Total, serious adverse events	STP1 Low Dose	0	6
Total, serious adverse events	STP1 High Dose	0	3
Total, serious adverse events	Placebo	0	3

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39062003	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04644003

GET https://conductscience.org/api/trials/v1/NCT04644003/events?page=2

API reference For AI assistants