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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-248

NCT04036227 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2023-10-11

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

GS-248

GS-248 oral solution

DRUG

Placebo

Placebo oral solution with the same composition to match active drug

Sponsors & Collaborators

  • CTC Clinical Trial Consultants AB

    collaborator INDUSTRY

  • Gesynta Pharma AB

    lead INDUSTRY

Principal Investigators

  • Folke Sjöberg, MD · CTC Clinical Trial Consultants AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-03
Primary Completion
2019-12-20
Completion
2019-12-20

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04036227 on ClinicalTrials.gov