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

NCT07780604 | Completed Phase 1 DMC

• 2 other identifiers: GAL-101-C010220240913
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (20)

Part 1: GAL-101 195 mg

EXPERIMENTAL

Healthy adult participants received a single oral dose of 195 mg GAL-101 salt as one enteric-coated capsule under fasting conditions on Day 1.

Drug: Enteric-Coated Capsules 195 mg

Part 1: Placebo-195 mg Cohort

PLACEBO COMPARATOR

Healthy adult participants received matching placebo corresponding to the 195 mg cohort under fasting conditions on Day 1.

Drug: Placebo

Part 1: GAL-101 390 mg

EXPERIMENTAL

Healthy adult participants received a single oral dose of 390 mg GAL-101 salt as two enteric-coated capsules under fasting conditions on Day 1.

Drug: Enteric-Coated Capsules 390 mg

Part 1: Placebo-390 mg Cohort

PLACEBO COMPARATOR

Healthy adult participants received a single oral dose of 390 mg GAL-101 salt as two enteric-coated capsules under fasting conditions on Day 1.

Drug: Placebo

Part 1: GAL-101 780 mg

EXPERIMENTAL

Healthy adult participants received a single oral dose of 780 mg GAL-101 salt as four enteric-coated capsules under fasting conditions on Day 1.

Drug: Enteric-Coated Capsules 780 mg

Part 1: Placebo-780 mg Cohort

PLACEBO COMPARATOR

Healthy adult participants received a single oral dose of 780 mg GAL-101 salt as four enteric-coated capsules under fasting conditions on Day 1.

Drug: Placebo

Part 1: GAL-101 1170 mg

EXPERIMENTAL

Healthy adult participants received a single oral dose of 1170 mg GAL-101 salt as six enteric-coated capsules under fasting conditions on Day 1.

Drug: Enteric-Coated Capsules 1170 mg

Part 1: Placebo-1170 mg Cohort

PLACEBO COMPARATOR

Healthy adult participants received a single oral dose of 1170 mg GAL-101 salt as six enteric-coated capsules under fasting conditions on Day 1.

Drug: Placebo

Part 1: GAL-101 1755 mg

EXPERIMENTAL

Healthy adult participants received a single oral dose of 1755 mg GAL-101 salt as nine enteric-coated capsules under fasting conditions on Day 1.

Drug: Enteric-Coated Capsules 1755 mg

Part 1: Placebo-1755 mg Cohort

PLACEBO COMPARATOR

Healthy adult participants received a single oral dose of 1755 mg GAL-101 salt as nine enteric-coated capsules under fasting conditions on Day 1.

Drug: Placebo

Part 2: Enteric-coated/Uncoated Sequence

EXPERIMENTAL

Participants received a single 1170 mg dose of GAL-101 salt as enteric-coated capsules in Period 1, followed by a single 1170 mg dose as uncoated GAL-101 salt mixed with apple sauce in Period 2. Both treatments were administered under fasting conditions, with a washout of at least 7 days.

Drug: Enteric-Coated Capsules 1170 mg

Part 2: Uncoated/Enteric-coated Sequence

EXPERIMENTAL

Participants received a single 1170 mg dose of uncoated GAL-101 salt mixed with apple sauce in Period 1, followed by a single 1170 mg dose as enteric-coated capsules in Period 2. Both treatments were administered under fasting conditions, with a washout of at least 7 days.

Drug: Uncoated GAL-101 Salt 1170 mg; Drug: Enteric-Coated Capsules 1170 mg

Part 3: Food-effect Sequence 1

EXPERIMENTAL

Participants received three single 1170 mg doses of uncoated GAL-101 salt mixed with apple sauce according to Sequence 1: under fasting conditions, after a standard meal, and after a high-fat, high-calorie meal, with a washout of at least 7 days between periods.

Drug: Enteric-Coated Capsules 1170 mg

Part 3: Food-effect Sequence 2

EXPERIMENTAL

Participants received three single 1170 mg doses of uncoated GAL-101 salt mixed with apple sauce according to Sequence 2: under fasting conditions, after a standard meal, and after a high-fat, high-calorie meal, with a washout of at least 7 days between periods.

Drug: Enteric-Coated Capsules 1170 mg

Part 4: GAL-101 780 mg Once Daily

EXPERIMENTAL

Healthy adult participants received 780 mg uncoated GAL-101 salt mixed with apple sauce orally once daily under fasting conditions for 7 days.

Drug: Uncoated GAL-101 Salt 780 mg

Part 4: Placebo-780 mg Cohort

PLACEBO COMPARATOR

Healthy adult participants received matching placebo orally once daily under fasting conditions for 7 days in the 780 mg cohort.

Drug: Placebo

Part 4: GAL-101 1170 mg Once Daily

EXPERIMENTAL

Healthy adult participants received 1170 mg uncoated GAL-101 salt mixed with apple sauce orally once daily under fasting conditions for 7 days.

Drug: Uncoated GAL-101 Salt 1170 mg

Part 4: Placebo-1170 mg Cohort

EXPERIMENTAL

Healthy elderly participants aged 65-85 years received a single oral dose of 1170 mg uncoated GAL-101 salt mixed with apple sauce under fasting conditions on Day 1.

Drug: Placebo; Drug: Enteric-Coated Capsules 1170 mg

Part 5: Placebo-Elderly

PLACEBO COMPARATOR

Healthy elderly participants aged 65-85 years received a single oral dose of 1170 mg uncoated GAL-101 salt mixed with apple sauce under fasting conditions on Day 1.

Drug: Placebo

Part 5: GAL-101 1170 mg-Elderly

EXPERIMENTAL

Healthy elderly participants aged 65-85 years received a single oral dose of 1170 mg uncoated GAL-101 salt mixed with apple sauce under fasting conditions on Day 1.

Drug: Enteric-Coated Capsules 1170 mg

Interventions

Uncoated GAL-101 Salt 1170 mg DRUG

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

Part 2: Uncoated/Enteric-coated Sequence; Part 4: GAL-101 1170 mg Once Daily

Placebo DRUG

Matching placebo administered orally under blinded conditions.

Part 1: Placebo-1170 mg Cohort; Part 1: Placebo-1755 mg Cohort; Part 1: Placebo-195 mg Cohort; Part 1: Placebo-390 mg Cohort; Part 1: Placebo-780 mg Cohort; Part 4: Placebo-1170 mg Cohort; Part 4: Placebo-780 mg Cohort; Part 5: Placebo-Elderly

Enteric-Coated Capsules 195 mg DRUG

195 mg

Part 1: GAL-101 195 mg

Enteric-Coated Capsules 390 mg DRUG

390 mg

Part 1: GAL-101 390 mg

Uncoated GAL-101 Salt 780 mg DRUG

780 mg

Part 4: GAL-101 780 mg Once Daily

Enteric-Coated Capsules 1755 mg DRUG

1755 mg

Part 1: GAL-101 1755 mg

Enteric-Coated Capsules 780 mg DRUG

780 mg

Part 1: GAL-101 780 mg

Enteric-Coated Capsules 1170 mg DRUG

1170 mg

Part 1: GAL-101 1170 mg; Part 2: Enteric-coated/Uncoated Sequence; Part 2: Uncoated/Enteric-coated Sequence; Part 3: Food-effect Sequence 1; Part 3: Food-effect Sequence 2; Part 4: Placebo-1170 mg Cohort; Part 5: GAL-101 1170 mg-Elderly

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galimedix Therapeutics Inc: lead

Study Sites (1)

FARMOVS

Bloemfontein, South Africa

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 21, 2026
• Study Start: November 18, 2024
• Primary Completion: September 18, 2025
• Study Completion: December 18, 2025
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)