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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03173625 | A Study Conducted in Healthy Male Subjects to Investigate the Safety and Tolerability of AC-76, Its Fate in the Body, and Its Effect on the Body | PHASE1 | COMPLETED | 72 | — | — | Nov 29, 2016 | Apr 15, 2017 | Jul 2, 2025 | 1 | United States |
Treatment-emergent AEs and treatment-emergent serious AEs
ECG variables are to be recorded at rest using a standard 12-lead ECG
Supine blood pressure (mmHg)
Pulse rate (bpm)
| Arm | Type | Description |
|---|---|---|
| AC-076 sc administration - single ascending dose | EXPERIMENTAL | On Day 1, 48 subjects will receive AC-076 at different single dose levels in a sequential manner and in a maximum of 6 dose levels, starting from 1 mg. Subjects will be followed by an observation period of 48 h. Each dose level will be investigated in a new group of 8 healthy male subjects (6 on active drug and 2 on placebo) |
| Placebo | PLACEBO_COMPARATOR | For each AC-076 dose level tested, 2 healthy male subjects will receive matching placebo in the same condition |
| Name | Type | Description |
|---|---|---|
| AC-076 for s.c. administration | DRUG | Lyophilized AC-076A to be reconstituted with 1 mL of water for injection |
| Placebo | DRUG | Sterile 0.9% w/v sodium chloride solution |
Inclusion Criteria: * Signed informed consent * Body mass index (BMI) of 18.0 to 31.0 kg/m2 (inclusive) at screening * Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 45-90 beats per minute (inclusive) at screening * Healthy on the basis of phys...