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Completed

NCT Number: NCT07780604

A SINGLE CENTER, 5-PART STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS 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.

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Key information

Conditions

Healthy Adult Participants

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

FARMOVS

Bloemfontein, South Africa

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Uncoated GAL-101 Salt 1170 mg

Drug

Uncoated GAL-101 salt obtained from the capsule contents, mixed with apple sauce and administered orally_1170mg

Placebo

Drug

Matching placebo administered orally under blinded conditions.

Enteric-Coated Capsules 195 mg

Drug

195 mg

Enteric-Coated Capsules 390 mg

Drug

390 mg

Uncoated GAL-101 Salt 780 mg

Drug

780 mg

Enteric-Coated Capsules 1755 mg

Drug

1755 mg

Enteric-Coated Capsules 780 mg

Drug

780 mg

Enteric-Coated Capsules 1170 mg

Drug

1170 mg

Primary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events

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

    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.

Sponsors and collaborators

Lead sponsor

Galimedix Therapeutics Inc

Industry

Registry information

Official study title

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

Acronym: GAL-101-C0102

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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