Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03285620 | A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants | PHASE1 | COMPLETED | 42 | — | — | Sep 7, 2017 | Nov 14, 2018 | Feb 3, 2025 | 1 | New Zealand |
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Severity of AEs will be graded according to the Division of Acquired Immune Deficiency Syndrome (DAIDS) Toxicity Grading Scale as follows: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (potentially life-threatening); and Grade 5 (death related to the AE).
Severity of AEs will be graded according to the Division of AIDS (DAIDS) Toxicity Grading Scale as follows: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (potentially life-threatening); and Grade 5 (death related to the AE).
Number of participants with clinically significant changes in the physical examination (including height, body weight measurement, and skin examination) will be reported.
Number of participants with clinically significant changes in the physical examination (including height, body weight measurement, and skin examination) will be reported.
Number of participants with vital signs abnormalities (vital signs includes body temperature, pulse rate, respiratory rate, oxygen saturation \[SaO2\] and blood pressure) will be reported.
Number of participants with vital signs abnormalities (vital signs includes body temperature, pulse rate, respiratory rate, oxygen saturation \[SaO2\] and blood pressure) will be reported.
Number of participants with clinical laboratory abnormalities (serum chemistry, hematology, and coagulation) will be reported.
Number of participants with clinical laboratory abnormalities (serum chemistry, hematology, and coagulation) will be reported.
Number of participants with Holter monitoring abnormalities (related to heart's activity such as rate and rhythm) will be reported.
Number of participants with Holter monitoring abnormalities (related to heart's activity such as rate and rhythm) will be reported.
Number of participants with electrocardiogram (ECG) abnormalities will be reported.
Number of participants with electrocardiogram (ECG) abnormalities will be reported.
Number of participants with CRS will be reported. CRS is defined as a disorder characterized by nausea, headache, tachycardia, hypotension, rash, and/or shortness of breath.
Number of participants with CRS will be reported. CRS is defined as a disorder characterized by nausea, headache, tachycardia, hypotension, rash, and/or shortness of breath.
Severity of CRS will be graded according to DAIDS as follows: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); and Grade 4 (potentially life-threatening).
Severity of CRS will be graded according to DAIDS as follows: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); and Grade 4 (potentially life-threatening).
The Cmax is the maximum observed concentration of AL-034 in plasma following single ascending dose (SAD) administration.
The Cmax is the maximum observed concentration of AL-034 in plasma following multiple ascending dose (MAD) administration.
AUC is the area under the plasma concentration time curve of AL-034 in plasma following SAD administration.
AUC is the area under the plasma concentration time curve of AL-034 in plasma following MAD administration.
Concentration in urine of AL-034 following a single dose administration will be determined.
Concentration in urine of AL-034 following MAD administration will be determined.
| Arm | Type | Description |
|---|---|---|
| Part 1: Single Ascending Dose (SAD) | EXPERIMENTAL | Participants will receive single oral dose of AL-034 (oral solution) (the starting dose in Cohort 1 of Part 1 will be 0.2 milligram \[mg\]) or matching placebo under fasted condition (Cohorts 1 to 5 or optional Cohort 7) on Day 1. Participants may receive AL-034 in a fed state (Cohort 6) to evaluate the effect of food on the pharmacokinetics (PK) of AL-034. |
| Part 2: Multiple-Dose Administration (MAD) | EXPERIMENTAL | Participants will receive multiple oral doses of AL-034 or matching placebo for 4 consecutive weeks either once weekly (Qwk - for 4 doses) or every two weeks (Q2wk - for 3 doses) under fed or fasted conditions. The starting dose for Part 2 will be determined based on the initial PK and safety/tolerability data from Part 1. |
| Name | Type | Description |
|---|---|---|
| AL-034 | DRUG | Participants will receive single oral dose of AL-034 under fed or fasted conditions in part 1 and part 2 |
| Placebo | DRUG | Participants will receive single oral dose of matching placebo (oral solution) under fed or fasted conditions in part 1 and part 2. |
INCLUSION CRITERIA Each potential participant must satisfy all of the following criteria to be enrolled in the study * participant must be a man or a woman between 18 and 55 years of age, extremes included * Female participant must be of non-childbearing potential, defined as: a) Postmenopausal: A ...