Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AC-076 for s.c. administration · 1 trial · 1 indication
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...
AC-076 for s.c. administration is an investigational small molecule being developed by Viatris Inc. (VTRS). It is currently in Phase 1 clinical development, studied in healthy subjects. The drug is administered subcutaneously, and its safety, tolerability, and pharmacokinetics are being evaluated.
AC-076 for s.c. administration is being studied in healthy subjects as part of early-phase clinical development. Its intended therapeutic use has not been established, as it is still in Phase 1 trials. The current study focuses on safety, tolerability, and how the body processes the drug.
AC-076 for s.c. administration is developed by Viatris Inc., a global healthcare company traded on the NASDAQ under the ticker VTRS. Viatris is conducting the Phase 1 clinical development of this investigational small molecule.
AC-076 for s.c. administration is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. A Phase 1 study in healthy subjects has been completed, evaluating safety, tolerability, and pharmacokinetics.
AC-076 for s.c. administration has one completed Phase 1 trial, NCT03173625, conducted in the United States. This randomized, double-blind, placebo-controlled study enrolled 72 healthy male subjects aged 18 years and older to assess safety, tolerability, and the drug's fate in the body.
AC-076 for s.c. administration is referred to as AC-76 in the clinical trial record. The Phase 1 study NCT03173625 is titled '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.'