MedTrace Logo

A SINGLE CENTER, 5-PART STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF GAL-101 SALT IN HEALTHY ADULT AND ELDERLY PARTICIPANTS

NCT07780604 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-08-21

No results posted yet for this study

Summary

This first-in-human Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of GAL-101 salt following oral administration to healthy adult and elderly participants. A total of 92 participants were enrolled at a single study center.

The study consisted of five parts. Part 1 evaluated single ascending doses of enteric-coated GAL-101 capsules compared with placebo in healthy adults. Part 2 compared a single dose of enteric-coated GAL-101 capsules with uncoated GAL-101 salt mixed with apple sauce in an open-label crossover design. Part 3 evaluated the effect of fasting, a standard meal, and a high-fat, high-calorie meal on the pharmacokinetics of a single dose of uncoated GAL-101 salt in an open-label crossover design. Part 4 evaluated multiple ascending doses of uncoated GAL-101 salt administered once daily for 7 days compared with placebo. Part 5 evaluated the pharmacokinetics of a single dose of uncoated GAL-101 salt compared with placebo in healthy elderly participants aged 65 to 85 years.

Conditions

  • Healthy Adult Participants

Interventions

DRUG

Uncoated GAL-101 Salt 1170 mg

Uncoated GAL-101 salt obtained from the capsule contents, mixed with apple sauce and administered orally\_1170mg

DRUG

Placebo

Matching placebo administered orally under blinded conditions.

DRUG

Enteric-Coated Capsules 195 mg

195 mg

DRUG

Enteric-Coated Capsules 390 mg

390 mg

DRUG

Uncoated GAL-101 Salt 780 mg

780 mg

DRUG

Enteric-Coated Capsules 1755 mg

1755 mg

DRUG

Enteric-Coated Capsules 780 mg

780 mg

DRUG

Enteric-Coated Capsules 1170 mg

1170 mg

Sponsors & Collaborators

  • Galimedix Therapeutics Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2024-11-18
Primary Completion
2025-09-18
Completion
2025-12-18

Countries

  • South Africa

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 NCT07780604 on ClinicalTrials.gov