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

A SINGLE CENTER, 5-PART, RANDOMIZED, DOUBLE-BLIND AND PLACEBO-CONTROLLED (Parts 1, 4, 5), OPEN-LABEL AND CROSSOVER (Parts 2, 3) STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF SINGLE AND MULTIPLE ASCENDING DOSES (Parts 1, 4), AND SINGLE DOSES (Parts 2, 3, 5), OF GAL-101 SALT IN HEALTHY ADULT AND ELDERLY PARTICIPANTS

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.

Key Inclusion Criteria:

• Healthy male or female participants, as determined by medical history, physical examination, vital signs, electrocardiogram, and clinical laboratory assessments.
• Aged [insert range] years for Parts 1-4 and 65-85 years for Part 5.
• Body mass index within [insert range] kg/m².
• Able and willing to provide written informed consent.
• Willing to comply with contraception requirements, where applicable.

Key Exclusion Criteria:

• Clinically significant cardiovascular, hepatic, renal, gastrointestinal, neurological, psychiatric, respiratory, hematological, or metabolic disease.
• Clinically significant abnormal laboratory, vital-sign, physical-examination, or electrocardiogram findings.
• Known hypersensitivity to GAL-101, related compounds, or formulation components.
• Use of prohibited prescription or nonprescription medication within the protocol-specified period.
• Positive testing for drugs of abuse, alcohol, or relevant infectious diseases.
• History of significant alcohol or substance misuse.
• Participation in another clinical study or receipt of another investigational product within the protocol-specified period.
• Blood donation or significant blood loss within the protocol-specified period.
• Pregnant or breastfeeding.
• Any condition that, in the investigator's opinion, could affect participant safety or study-result interpretation.