Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
C106 · 1 trial · 4 indications
AE reporting and questioning. AEs must be recorded in the AE Log of the eCRF. The Investigator must provide information on the AE, preferably with a diagnosis or at least with signs and symptoms; start and stop dates, start and stop time; intensity; causal relationship to IMP; action taken, and outcome. If the AE is serious, this must be indicated in the eCRF. AEs, including out-of-range clinically significant clinical safety laboratory values, must be recorded individually, except when considered manifestations of the same medical condition or disease state; in such cases, they must be recorded under a single diagnosis. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Single 12-lead ECG will be recorded in supine position after 10 minutes of rest using an ECG machine. Abnormalities will be specified and documented as clinically significant or not clinically significant. Heart rate (HR) and PR, QRS, QT, and QTcF intervals were recorded.
Systolic and diastolic blood pressure and pulse were measured in supine position after 10 minutes of rest. The respiratory rate was assessed. Body temperature was measured using a digital thermometer on Day -1 of each part.
Blood samples for analysis of clinical chemistry, haematology, and coagulation parameters were collected through venepuncture or an indwelling venous catheter.
Any abnormalities will be specified and documented as clinically significant or not clinically significant. Abnormal findings assessed as clinically significant will be reported as AEs. A complete physical examination will include assessments of the head, eyes, ears, nose, throat, skin, neurological, lungs, cardiovascular, and abdomen. .
| Arm | Type | Description |
|---|---|---|
| C106 solution | EXPERIMENTAL | Part A: Oral administration start dose, Single dose 5 mg Part B: Oral administration start dose 20 mg twice daily for 8 days |
| Placebo | PLACEBO_COMPARATOR | Part A and B: Placebo to C106 without the active pharmaceutical ingredient |
| Name | Type | Description |
|---|---|---|
| C106 solution | DRUG | selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist |
| Placebo | DRUG | Placebo for C106 solution |
Inclusion Criteria: 1. Willing and able to give written informed consent for participation in the trial. 2. Healthy males and females of non-childbearing potential aged 18-65 years inclusive. 3. Body Mass Index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 4. Clinically normal medical history, physical findings, v...
C106 is an investigational small molecule being developed for cardiovascular conditions, specifically studied in the context of safety, tolerance, idiopathic pulmonary fibrosis, and pulmonary hypertension. It is currently in Phase 1 clinical development and is not yet approved for any use.
C106 is being developed by Vicore Pharma Holding AB, a biopharmaceutical company. The company is publicly traded under the ticker symbol VCRE on the American stock exchange.
C106 is in Phase 1 clinical development. A first-in-human trial has been completed, evaluating the safety, tolerability, and pharmacokinetics of the drug in healthy subjects. It remains investigational and has not received regulatory approval.
C106 has one completed clinical trial, identified as NCT05427253. This was a first-in-human, Phase 1 study conducted in Sweden with 80 healthy volunteers. The trial was randomized, double-blind, and placebo-controlled, assessing safety, tolerability, and pharmacokinetics.
The specific molecular target of C106 has not been disclosed. As a small molecule in the cardiovascular therapeutic area, it is being investigated for its potential effects on conditions such as pulmonary hypertension and idiopathic pulmonary fibrosis, but its mechanism of action is not publicly detailed.