NCT05427253

First-in-human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of C106 in Healthy Subjects

Completed Phase 1 Results posted Last updated 31 January 2025

What this trial tests

Phase 1 trial testing C106 solution in Safety Issues in 80 participants. Completed in 22 June 2023.

Timeline

8 June 2022

Primary endpoint
22 June 2023

22 June 2023

Quick facts

Lead sponsor	Vicore Pharma AB
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	basic science
Enrollment	80
Start date	8 June 2022
Primary completion	22 June 2023
Estimated completion	22 June 2023
Sites	1 location across Sweden

Drugs / interventions tested

• C106 solution — full drug profile →
• Placebo

Conditions studied

• Safety Issues — all drugs for Safety Issues →
• Tolerance — all drugs for Tolerance →
• Idiopathic Pulmonary Fibrosis — all drugs for Idiopathic Pulmonary Fibrosis →
• Pulmonary Hypertension — all drugs for Pulmonary Hypertension →

Sponsor

Vicore Pharma AB — full company profile →

Who can join

Adults 18 to 65, any sex, with Safety Issues or Tolerance. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Number of Treatment Emergent Adverse Events (AEs) and Serious AEs (SAEs) Primary · From date of signing informed consent until End of Study, assessed up to Day 22

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 recor

Adverse events

Group	Value	95% CI
SAD Part Cohort 1, Dose 5 mg	5
SAD Part Cohort 2, Dose 30 mg	5
SAD Part Cohort 3, Dose 60 mg	3
SAD Part Cohort 4, Dose 180 mg	2
SAD Part Cohort 4, Dose 180 mg Fed	2
SAD Part Cohort 5, Dose 240 mg	7
SAD Part, Cohort 6, Dose 300 mg	8
SAD Part, Placebo	4
MAD Part, Dose 40mg	11
MAD Part, Dose 100mg	10
MAD Part, Dose 140mg	15
MAD Part, Dose 180mg	7

Serious Adverse events

Group	Value	95% CI
SAD Part Cohort 1, Dose 5 mg	0
SAD Part Cohort 2, Dose 30 mg	0
SAD Part Cohort 3, Dose 60 mg	0
SAD Part Cohort 4, Dose 180 mg	0
SAD Part Cohort 4, Dose 180 mg Fed	0
SAD Part Cohort 5, Dose 240 mg	0
SAD Part, Cohort 6, Dose 300 mg	0
SAD Part, Placebo	0
MAD Part, Dose 40mg	0
MAD Part, Dose 100mg	0
MAD Part, Dose 140mg	0
MAD Part, Dose 180mg	0

Number of Reported Clinically Significant Changes From Baseline in 12-lead Electrocardiograms (ECGs) Primary · Part A: Up to Day 10. Part B: Up to Day 22.

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.

Group	Value	95% CI
SAD Part Cohort 1, Dose 5 mg	0
SAD Part Cohort 2, Dose 30 mg	0
SAD Part Cohort 3, Dose 60 mg	1
SAD Part Cohort 4, Dose 180 mg	0
SAD Part Cohort 4, Dose 180 mg Fed	0
SAD Part Cohort 5, Dose 240 mg	1
SAD Part, Cohort 6, Dose 300 mg	0
SAD Part, Placebo	0
MAD Part, Dose 40mg	0
MAD Part, Dose 100mg	0
MAD Part, Dose 140mg	1
MAD Part, Dose 180mg	0

Number of Reported Clinically Significant Changes in Vital Signs Primary · Part A: Up to Day 3, Part B: Up to Day 10. Vital signs were measured at pre-defined timepoints during the trial.

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 pressure

Group	Value	95% CI
SAD Part Cohort 1, Dose 5 mg	0
SAD Part Cohort 2, Dose 30 mg	0
SAD Part Cohort 3, Dose 60 mg	0
SAD Part Cohort 4, Dose 180 mg	0
SAD Part Cohort 4, Dose 180 mg Fed	0
SAD Part Cohort 5, Dose 240 mg	1
SAD Part, Cohort 6, Dose 300 mg	1
SAD Part, Placebo	0
MAD Part, Dose 40mg	0
MAD Part, Dose 100mg	0
MAD Part, Dose 140mg	1
MAD Part, Dose 180mg	0

Pulse

Group	Value	95% CI
SAD Part Cohort 1, Dose 5 mg	0
SAD Part Cohort 2, Dose 30 mg	0
SAD Part Cohort 3, Dose 60 mg	0
SAD Part Cohort 4, Dose 180 mg	0
SAD Part Cohort 4, Dose 180 mg Fed	0
SAD Part Cohort 5, Dose 240 mg	0
SAD Part, Cohort 6, Dose 300 mg	0
SAD Part, Placebo	0
MAD Part, Dose 40mg	0
MAD Part, Dose 100mg	0
MAD Part, Dose 140mg	0
MAD Part, Dose 180mg	0

Respiratory rate

Group	Value	95% CI
SAD Part Cohort 1, Dose 5 mg	0
SAD Part Cohort 2, Dose 30 mg	0
SAD Part Cohort 3, Dose 60 mg	0
SAD Part Cohort 4, Dose 180 mg	0
SAD Part Cohort 4, Dose 180 mg Fed	0
SAD Part Cohort 5, Dose 240 mg	0
SAD Part, Cohort 6, Dose 300 mg	0
SAD Part, Placebo	0
MAD Part, Dose 40mg	2
MAD Part, Dose 100mg	1
MAD Part, Dose 140mg	0
MAD Part, Dose 180mg	1

Number of Clinically Significant Changes in Laboratory Safety Variables (Haematology, Coagulation, Clinical Chemistry and Urine Analysis) Primary · Part A: Up to Day 3, Part B: Up to Day 10. Safety laboratory samples were collected at pre-defined timepoints during the trial.

Blood samples for analysis of clinical chemistry, haematology, and coagulation parameters were collected through venepuncture or an indwelling venous catheter.

Clinical chemistry

Group	Value	95% CI
SAD Part Cohort 1, Dose 5 mg	0
SAD Part Cohort 2, Dose 30 mg	0
SAD Part Cohort 3, Dose 60 mg	0
SAD Part Cohort 4, Dose 180 mg	0
SAD Part Cohort 4, Dose 180 mg Fed	0
SAD Part Cohort 5, Dose 240 mg	1
SAD Part, Cohort 6, Dose 300 mg	0
SAD Part, Placebo	0
MAD Part, Dose 40mg	0
MAD Part, Dose 100mg	0
MAD Part, Dose 140mg	0
MAD Part, Dose 180mg	0

Haematology

Group	Value	95% CI
SAD Part Cohort 1, Dose 5 mg	0
SAD Part Cohort 2, Dose 30 mg	0
SAD Part Cohort 3, Dose 60 mg	0
SAD Part Cohort 4, Dose 180 mg	0
SAD Part Cohort 4, Dose 180 mg Fed	0
SAD Part Cohort 5, Dose 240 mg	0
SAD Part, Cohort 6, Dose 300 mg	0
SAD Part, Placebo	0
MAD Part, Dose 40mg	0
MAD Part, Dose 100mg	0
MAD Part, Dose 140mg	0
MAD Part, Dose 180mg	0

Coagulation

Group	Value	95% CI
SAD Part Cohort 1, Dose 5 mg	0
SAD Part Cohort 2, Dose 30 mg	0
SAD Part Cohort 3, Dose 60 mg	0
SAD Part Cohort 4, Dose 180 mg	0
SAD Part Cohort 4, Dose 180 mg Fed	0
SAD Part Cohort 5, Dose 240 mg	0
SAD Part, Cohort 6, Dose 300 mg	0
SAD Part, Placebo	0
MAD Part, Dose 40mg	0
MAD Part, Dose 100mg	0
MAD Part, Dose 140mg	0
MAD Part, Dose 180mg	0

Urinalysis

Group	Value	95% CI
SAD Part Cohort 1, Dose 5 mg	0
SAD Part Cohort 2, Dose 30 mg	0
SAD Part Cohort 3, Dose 60 mg	0
SAD Part Cohort 4, Dose 180 mg	0
SAD Part Cohort 4, Dose 180 mg Fed	0
SAD Part Cohort 5, Dose 240 mg	0
SAD Part, Cohort 6, Dose 300 mg	0
SAD Part, Placebo	0
MAD Part, Dose 40mg	0
MAD Part, Dose 100mg	0
MAD Part, Dose 140mg	0
MAD Part, Dose 180mg	0

Number of Reported Clinically Significant Changes in Physical Examinations. Primary · Physical examination was performed at pre-defined timepoints during the trial. Part A: Day 7, Part B: Day 22

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. .

Group	Value	95% CI
SAD Part Cohort 1, Dose 5 mg	0
SAD Part Cohort 2, Dose 30 mg	0
SAD Part Cohort 3, Dose 60 mg	0
SAD Part Cohort 4, Dose 180 mg	0
SAD Part Cohort 4, Dose 180 mg Fed	0
SAD Part Cohort 5, Dose 240 mg	0
SAD Part, Cohort 6, Dose 300 mg	0
SAD Part, Placebo	0
MAD Part, Dose 40mg	0
MAD Part, Dose 100mg	0
MAD Part, Dose 140mg	0
MAD Part, Dose 180mg	0

Adverse events — posted to ClinicalTrials.gov

Time frame: AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SAD Part Cohort 1, Dose 5 mg

Serious: 0/6 (0%)

Deaths: 0/6

SAD Part Cohort 2, Dose 30 mg

Serious: 0/6 (0%)

Deaths: 0/6

SAD Part Cohort 3, Dose 60 mg

Serious: 0/6 (0%)

Deaths: 0/6

SAD Part Cohort 4, Dose 180 mg

Serious: 0/6 (0%)

Deaths: 0/6

SAD Part Cohort 4, Dose 180 mg Fed

Serious: 0/5 (0%)

Deaths: 0/5

SAD Part Cohort 5, Dose 240 mg

Serious: 0/6 (0%)

Deaths: 0/6

SAD Part, Cohort 6, Dose 300 mg

Serious: 0/6 (0%)

Deaths: 0/6

SAD Part, Placebo

Serious: 0/12 (0%)

Deaths: 0/12

MAD Part, Dose 40mg

Serious: 0/6 (0%)

Deaths: 0/6

MAD Part, Dose 100mg

Serious: 0/6 (0%)

Deaths: 0/6

MAD Part, Dose 140mg

Serious: 0/6 (0%)

Deaths: 0/6

MAD Part, Dose 180mg

Serious: 0/6 (0%)

Deaths: 0/6

MAD Part, Placebo

Serious: 0/8 (0%)

Deaths: 0/8

Other adverse events (48 terms — click to expand)

Reaction	System	SAD Part Cohort 1, Dose 5 mg	SAD Part Cohort 2, Dose 30…	SAD Part Cohort 3, Dose 60…	SAD Part Cohort 4, Dose 18…	SAD Part Cohort 4, Dose 18…	SAD Part Cohort 5, Dose 24…	SAD Part, Cohort 6, Dose 3…	SAD Part, Placebo	MAD Part, Dose 40mg	MAD Part, Dose 100mg	MAD Part, Dose 140mg	MAD Part, Dose 180mg	MAD Part, Placebo
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—
Blood pressure increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Respiratory rate decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Restless legs syndrome	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypoesthesia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Malaise	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Swelling	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Chest discomfort	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Chest pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Feeling hot	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypoaesthesia oral	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Arthropod sting	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—
Vascular access site inflammation	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyperhidrosis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Skin burning sensation	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Onychoclasis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Atrioventricular block second degree	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Bradycardia	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Atrioventricular block first degree	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—
Tooth infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—
Blepharospasm	Eye disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Eye paraesthesia	Eye disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT05427253 adverse events section.

Sponsor's own description

This is a FIH, double-blind, placebo-controlled, within-group randomised, trial designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending oral doses of compound 106 (C106) in healthy females of non-childbearing potential and healthy males.

The trial will be conducted in 2 parts:

Part A, single ascending dose (SAD) including a food interaction cohort: safety, tolerability, and PK in healthy males and healthy females of non-childbearing potential receiving single ascending doses of C106.

Part B, multiple ascending dose (MAD): safety, tolerability, and PK in healthy males and healthy females of non-childbearing potential receiving twice daily multiple ascending doses of C106 for 8 days.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.