Clinical Trials Logo
  1. Home
  2. Safety and Tolerability
  3. NCT03809052

A First in Human Study to Evaluate the Safety, Tolerability and PK of GB1211 in Healthy Subjects

Safety and Tolerability Clinical Trial

Official title:
GB1211 - A Randomised, Double-Blind, Placebo-Controlled, First-In-Human, Study of Orally Administered GB1211 to Evaluate the Safety, Tolerability, and PK of Single Ascending Doses (SAD) and Multiple Ascending Doses (MAD) in Healthy Subjects

Clinical Trial Summary

This was a Phase 1, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetics of orally administered GB1211 will be evaluated in healthy adult subjects and adult subjects with indication of suspected Nonalcoholic steatohepatitis (NASH) and liver fibrosis.

Clinical Trial Description

The study consisted of 2 parts: a SAD phase (Part A) which enrolled a total of 5 cohorts of healthy subjects and a MAD phase (Part B) which enrolled 2 cohorts of healthy subjects. Two additional cohorts A6 and A7, were added following dose escalation analysis. The planned optional Part C was to include a multiple-dose cohort of 25 subjects with suspected NASH and liver fibrosis (Cohort C1). However, Part C of the study was not performed as per Sponsor's decision. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03809052
Study type Interventional
Source Galecto Biotech AB
Contact
Status Completed
Phase Phase 1
Start date January 14, 2019
Completion date June 25, 2019
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05997641 - Evaluating the Safety, Tolerability, and Pharmacokinetics of DF-003 in Healthy Subjects Phase 1
Recruiting NCT06000891 - A Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570 Phase 1
Completed NCT06181760 - A Study to Evaluate the Safety of Fenretinide in Healthy Volunteers Phase 1
Recruiting NCT05907382 - Safety, Tolerability of JMKX003002 in Phase 1 Study in Healthy Subjects Phase 1
Completed NCT01952548 - Study Comparing the Pharmacokinetics, Pharmacodynamics, and Safety of K-312 in Healthy Adult Volunteers Phase 1
Completed NCT05431634 - Multiple Dose Study to Determine Safety and Tolerability of ESK-001 in Healthy Participants Phase 1
Recruiting NCT06331884 - Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics/-Dynamics of AK1967 (Procizumab) Phase 1
Completed NCT03046589 - DP13 SAD & MAD in Healthy Male Subjects Phase 1
Recruiting NCT06079541 - Phase 1 Clinical Study of JMKX003142 Tablets Phase 1
Completed NCT05223660 - A Phase I Pharmacokinetics Study for KT07 Capsule Phase 1
Completed NCT01907867 - Pharmacokinetic Profile in Plasma and Epithelial Lining Fluid of Finafloxacin Phase 1
Completed NCT03853421 - Placebo-controlled Study to Determine the Safety and Tolerability of Subcutaneous Doses of Sevuparin Phase 1
Terminated NCT03307512 - PK and PD Profile of Dance 501 in Healthy, Non-diabetic Subjects With Mild to Moderate Asthma or COPD Phase 2
Completed NCT03702231 - Response to the SHINGRIX Varicella Zoster Virus (VZV) Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's Tyrosine Kinase Inhibitor (BTK-I) Phase 2
Completed NCT03685708 - HEPLISAV-B Hepatitis B Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's-Tyrosine Kinase Inhibitor (BTK-I) Phase 2
Completed NCT03817346 - Study of Ascending Single Oral Dose of GT-002 in Healthy Volunteers Phase 1
Active, not recruiting NCT01226316 - Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules Phase 1
Completed NCT05451667 - Single-Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of YJ001 in Healthy Volunteers Phase 1
Completed NCT02029482 - Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-128800 in Healthy Subjects Phase 1