NCT04036227

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-248

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Gesynta Pharma AB · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

Part I (SAD); In the SAD part of the study, single oral doses of GS-248 will be administered in 6 sequential cohorts, each consisting of 8 subjects randomised to receive either GS 248 or placebo in a 3:1 ratio. The first 2 subjects in each cohort will be dosed in a sentinel fashion; 1 subject will receive GS-248 and the other will receive placebo as randomised. The subjects will be carefully monitored by clinical staff during and after dosing. Vital signs, safety laboratory and ECG will be checked at regular intervals. Part II (MAD); The MAD part of the study will explore multiple ascending dosing of GS-248 administered for 10 days. The proposed starting dose is 25 mg/day. However, the starting dose as well as subsequent dose levels may be adjusted based on safety and PK evaluation in previous cohorts. GS-248 will be administered in 4 sequential cohorts, each of 8 subjects randomised to receive either GS 248 or placebo in a 3:1 ratio. The subjects will be carefully monitored by clinical staff during and after dosing. Vital signs, safety laboratory and ECG will be checked at regular intervals.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GS-248	GS-248 oral solution
DRUG	Placebo	Placebo oral solution with the same composition to match active drug

Timeline

• Start date: 2019-07-03
• Primary completion: 2019-12-20
• Completion: 2019-12-20
• First posted: 2019-07-29
• Last updated: 2023-10-11
• Results posted: 2023-09-08

Locations

1 site across 1 country: Sweden