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 developed by Viatris Inc. for subcutaneous administration. It has been studied in a Phase 1 clinical trial in healthy male volunteers in the United States. The specific therapeutic indication for AC-076 has not been disclosed.
AC-076 is being developed by Viatris Inc., which trades on the Nasdaq under the ticker VTRS. Viatris is the sponsor of the clinical program evaluating AC-076 for subcutaneous administration.
AC-076 is in Phase 1 clinical development. One Phase 1 trial of AC-076 has been completed, and no trials are currently active. The program remains investigational and has not been approved by the FDA.
AC-076 was evaluated in a single Phase 1 trial, NCT03173625, titled a study in healthy male subjects to investigate the safety and tolerability of AC-76, its fate in the body, and its effect on the body. The trial enrolled 72 participants in the United States and has been completed.
The Phase 1 trial of AC-076, NCT03173625, was a randomized, double-blind, placebo-controlled study. It enrolled 72 healthy male volunteers aged 18 years and older in the United States. The study assessed safety, tolerability, pharmacokinetics, and pharmacodynamics of AC-076.