CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 72 enrolled
Drug / intervention
GS-248 +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.

Search/NCT04036227
NCT04036227Phase 1Completed
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A Phase I, Placebo-controlled, Double-blind, First-in-human Study to Investigate Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GS-248 Solution in Healthy Subjects and Patients With Systemic Sclerosis (SSc)

Gesynta Pharma AB·interventional·Posted Jul 29, 2019·Updated Oct 11, 2023

In Brief

A Phase 1 clinical trial evaluating GS-248 and Placebo for Healthy. Completed, enrolled 72 participants across 1 site.

Detailed Summary

This is a First in Human (FIH), double-blinded, parallel-group, randomised, placebo-controlled study designed to evaluate the safety, tolerability, PK and PD of single and multiple ascending oral doses of GS-248 in healthy subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesSweden
CollaboratorsCTC Clinical Trial Consultants AB

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedJul 29, 2019
Enrollment StartJul 3, 2019
Primary CompletionDec 20, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.9 years ago

Interventions

GS-248drug

GS-248 oral solution

Placebodrug

Placebo oral solution with the same composition to match active drug