A Phase 1 interventional study of Uncoated GAL-101 Salt 1170 mg and Placebo in Healthy Adult Participants, sponsored by Galimedix Therapeutics Inc. Completed at 1 site in South Africa. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Galimedix Therapeutics Inc · Phase 1, Interventional, and Treatment
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).
Galimedix Therapeutics Inc is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Healthy adult participants received matching placebo corresponding to the 195 mg cohort under fasting conditions on Day 1.
Drug: Placebo
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
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
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
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
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
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
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
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
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
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
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
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
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
Healthy adult participants received matching placebo orally once daily under fasting conditions for 7 days in the 780 mg cohort.
Drug: Placebo
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
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
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
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
Uncoated GAL-101 salt obtained from the capsule contents, mixed with apple sauce and administered orally\_1170mg
Matching placebo administered orally under blinded conditions.
195 mg
390 mg
780 mg
1755 mg
780 mg
1170 mg
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
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2024 to primary completion in Sep 2025, 10 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Galimedix Therapeutics Inc