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Also known as C106 solution
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 developed by Vicore Pharma Holding AB, traded on the Nasdaq under the ticker VCRE. It has been studied in a Phase 1 first-in-human trial evaluating safety, tolerability, and pharmacokinetics in healthy adult subjects. C106 is also referred to as C106 solution.
C106 has been studied in a Phase 1 clinical trial that listed safety issues, tolerance, idiopathic pulmonary fibrosis, and pulmonary hypertension among its conditions. The trial enrolled healthy volunteers rather than patients, so C106 has not been established as a treatment for any indication.
C106 is developed by Vicore Pharma Holding AB, whose American Depositary Shares trade under the ticker VCRE. The company sponsored the Phase 1 first-in-human trial of C106 conducted in Sweden.
C106 is in Phase 1 development. Its single clinical trial, NCT05427253, was a first-in-human Phase 1 study evaluating safety, tolerability, and pharmacokinetics in healthy subjects. That trial is completed, and no active trials of C106 are currently listed.
C106 has been evaluated in one clinical trial, NCT05427253, titled First-in-human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of C106 in Healthy Subjects. The Phase 1 study enrolled 80 participants in Sweden, was randomized, double-blind, and placebo-controlled, and is completed.
Yes, C106 solution is another name for C106, the investigational small molecule developed by Vicore Pharma Holding AB under the ticker VCRE. Both names refer to the same asset studied in the Phase 1 trial NCT05427253.