Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Uncoated GAL-101 Salt · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| 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 |
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. * Abl...