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

Galimedix Therapeutics Inc92 enrolled

Overview

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.

GAL-101 as eye drops was previously evaluated in a Phase 1 study in healthy volunteers and Glaucoma (ClinicalTrials.gov Identifier: NCT01714960).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy Adult Participants

Uncoated GAL-101 Salt 1170 mgDRUG

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

PlaceboDRUG

Matching placebo administered orally under blinded conditions.

Enteric-Coated Capsules 195 mgDRUG

195 mg

Enteric-Coated Capsules 390 mgDRUG

390 mg

Uncoated GAL-101 Salt 780 mgDRUG

780 mg

Enteric-Coated Capsules 1755 mgDRUG

1755 mg

Enteric-Coated Capsules 780 mgDRUG

780 mg

Enteric-Coated Capsules 1170 mgDRUG

1170 mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

Key Inclusion Criteria: * Healthy male or female participants, as determined by medical history, physical examination, vital signs, electrocardiogram, and clinical laboratory assessments. * Aged years 18-60 for Parts 1-4 and 65-85 years for Part 5. * Body mass index between 18.5 and 30 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.

Outcomes

Primary Outcomes

Number of Participants With Treatment-Emergent Adverse Events

Treatment-emergent adverse events, serious adverse events, adverse events of special interest, and dose-limiting toxicities were assessed after administration of GAL-101 salt or placebo. Events were evaluated by severity and relationship to the study intervention.

Time frame: From the first dose through 28 days after the participant's last dose