Healthy Adult ParticipantsPhase 1GAL-101-C0102NCT07780604
A SINGLE CENTER, 5-PART STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF GAL-101 SALT IN HEALTHY ADULT AND ELDERLY PARTICIPANTS
A Phase 1 study testing Uncoated GAL-101 Salt 1170 mg, Enteric-Coated Capsules 195 mg and Enteric-Coated Capsules 390 mg in people with Healthy Adult Participants, run by Galimedix Therapeutics Inc at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- Uncoated GAL-101 Salt 1170 mg, Enteric-Coated Capsules 195 mg and Enteric-Coated Capsules 390 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteSouth Africa
- Study dates
- 18 Nov 2024to 18 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
GAL-101 as eye drops was previously evaluated in a Phase 1 study in healthy volunteers and Glaucoma (ClinicalTrials.gov Identifier: NCT01714960).
- Conditions
- Healthy Adult Participants
- Being tested
- Uncoated GAL-101 Salt 1170 mg, Placebo, Enteric-Coated Capsules 195 mg, Enteric-Coated Capsules 390 mg, Uncoated GAL-101 Salt 780 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Enteric-Coated Capsules 1170 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the first dose through 28 days after the participant's last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start18 Nov 2024
- Primary completion18 Sep 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galimedix Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780604
- Sponsor's protocol ID
- GAL-101-C0102
- Other IDs
- 20240913
- Acronym
- GAL-101-C0102
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07780604
- Acronym / sponsor ID
- GAL-101-C0102 / GAL-101-C0102
- Conditions
- Healthy Adult Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Galimedix Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 18 Sep 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
GAL-101 as eye drops was previously evaluated in a Phase 1 study in healthy volunteers and Glaucoma (ClinicalTrials.gov Identifier: NCT01714960).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 20
| Arm | Type | Receives |
|---|---|---|
| Part 1: GAL-101 195 mg | Experimental | Drug: Enteric-Coated Capsules 195 mgHealthy adult participants received a single oral dose of 195 mg GAL-101 salt as one enteric-coated capsule under fasting conditions on Day 1. |
| Part 1: Placebo-195 mg Cohort | Placebo comparator | Drug: PlaceboHealthy adult participants received matching placebo corresponding to the 195 mg cohort under fasting conditions on Day 1. |
| Part 1: GAL-101 390 mg | Experimental | Drug: Enteric-Coated Capsules 390 mgHealthy adult participants received a single oral dose of 390 mg GAL-101 salt as two enteric-coated capsules under fasting conditions on Day 1. |
| Part 1: Placebo-390 mg Cohort | Placebo comparator | Drug: PlaceboHealthy adult participants received a single oral dose of 390 mg GAL-101 salt as two enteric-coated capsules under fasting conditions on Day 1. |
| Part 1: GAL-101 780 mg | Experimental | Drug: Enteric-Coated Capsules 780 mgHealthy adult participants received a single oral dose of 780 mg GAL-101 salt as four enteric-coated capsules under fasting conditions on Day 1. |
| Part 1: Placebo-780 mg Cohort | Placebo comparator | Drug: PlaceboHealthy adult participants received a single oral dose of 780 mg GAL-101 salt as four enteric-coated capsules under fasting conditions on Day 1. |
| Part 1: GAL-101 1170 mg | Experimental | Drug: Enteric-Coated Capsules 1170 mgHealthy adult participants received a single oral dose of 1170 mg GAL-101 salt as six enteric-coated capsules under fasting conditions on Day 1. |
| Part 1: Placebo-1170 mg Cohort | Placebo comparator | Drug: PlaceboHealthy adult participants received a single oral dose of 1170 mg GAL-101 salt as six enteric-coated capsules under fasting conditions on Day 1. |
| Part 1: GAL-101 1755 mg | Experimental | Drug: Enteric-Coated Capsules 1755 mgHealthy adult participants received a single oral dose of 1755 mg GAL-101 salt as nine enteric-coated capsules under fasting conditions on Day 1. |
| Part 1: Placebo-1755 mg Cohort | Placebo comparator | Drug: PlaceboHealthy adult participants received a single oral dose of 1755 mg GAL-101 salt as nine enteric-coated capsules under fasting conditions on Day 1. |
| Part 2: Enteric-coated/Uncoated Sequence | Experimental | Drug: Enteric-Coated Capsules 1170 mgParticipants 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. |
| Part 2: Uncoated/Enteric-coated Sequence | Experimental | Drug: Uncoated GAL-101 Salt 1170 mg, Drug: Enteric-Coated Capsules 1170 mgParticipants 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. |
| Part 3: Food-effect Sequence 1 | Experimental | Drug: Enteric-Coated Capsules 1170 mgParticipants 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. |
| Part 3: Food-effect Sequence 2 | Experimental | Drug: Enteric-Coated Capsules 1170 mgParticipants 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. |
| Part 4: GAL-101 780 mg Once Daily | Experimental | Drug: Uncoated GAL-101 Salt 780 mgHealthy adult participants received 780 mg uncoated GAL-101 salt mixed with apple sauce orally once daily under fasting conditions for 7 days. |
| Part 4: Placebo-780 mg Cohort | Placebo comparator | Drug: PlaceboHealthy adult participants received matching placebo orally once daily under fasting conditions for 7 days in the 780 mg cohort. |
| Part 4: GAL-101 1170 mg Once Daily | Experimental | Drug: Uncoated GAL-101 Salt 1170 mgHealthy adult participants received 1170 mg uncoated GAL-101 salt mixed with apple sauce orally once daily under fasting conditions for 7 days. |
| Part 4: Placebo-1170 mg Cohort | Experimental | Drug: Placebo, Drug: Enteric-Coated Capsules 1170 mgHealthy 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. |
| Part 5: Placebo-Elderly | Placebo comparator | Drug: PlaceboHealthy 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. |
| Part 5: GAL-101 1170 mg-Elderly | Experimental | Drug: Enteric-Coated Capsules 1170 mgHealthy 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uncoated GAL-101 Salt 1170 mgUncoated GAL-101 salt obtained from the capsule contents, mixed with apple sauce and administered orally_1170mg | Drug | Part 2: Uncoated/Enteric-coated Sequence, Part 4: GAL-101 1170 mg Once Daily |
| PlaceboMatching placebo administered orally under blinded conditions. | Drug | 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 mg195 mg | Drug | Part 1: GAL-101 195 mg |
| Enteric-Coated Capsules 390 mg390 mg | Drug | Part 1: GAL-101 390 mg |
| Uncoated GAL-101 Salt 780 mg780 mg | Drug | Part 4: GAL-101 780 mg Once Daily |
| Enteric-Coated Capsules 1755 mg1755 mg | Drug | Part 1: GAL-101 1755 mg |
| Enteric-Coated Capsules 780 mg780 mg | Drug | Part 1: GAL-101 780 mg |
| Enteric-Coated Capsules 1170 mg1170 mg | Drug | 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 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Uncoated GAL-101 Salt 1170 mg, Enteric-Coated Capsules 195 mg and Enteric-Coated Capsules 390 mg in people with Healthy Adult Participants, run by Galimedix Therapeutics Inc at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (time frame: From the first dose through 28 days after the participant's last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.