Safety IssuesPhase 1NCT05427253

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

A Phase 1 study testing C106 solution in people with Safety Issues and Tolerance, run by Vicore Pharma AB at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Safety Issues, Tolerance, Idiopathic Pulmonary Fibrosis
What is being tested?: C106 solution
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteSweden
Study dates: 8 Jun 2022to 22 Jun 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Willing and able to give written informed consent for participation in the trial.
Healthy males and females of non-childbearing potential aged 18-65 years inclusive.
Body Mass Index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2
Clinically normal medical history, physical findings, vital signs, ECG, and laboratory values at the time of screening, as judged by the Investigator
Women of non-childbearing potential, defined as pre-menopausal females who are sterilized (tubal ligation or permanent bilateral occlusion of fallopian tubes); or females who have undergone hysterectomy or bilateral oophorectomy; or post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with simultaneous detection of follicle stimulating hormone [FSH] ≥ 25 IU/L is confirmatory).
Male subjects must be willing to use condom or be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of dosing until 3 months after (last) dosing with the IMP. Their female partner of child-bearing potential must use highly effective contraceptive methods with a failure rate of < 1% to prevent pregnancy (combined [oestrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD]or intrauterine hormone-releasing system [IUS]) from at least 4 weeks prior to dose to 3 months after last dose.

Who cannot join

History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the trial, or influence the results or the subject's ability to participate in the trial.
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
Malignancy within the past 5 years except for in situ removal of basal cell carcinoma.
Any planned major surgery within the duration of the trial.
Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV).
After 10 minutes supine rest at the time of screening, any vital signs values outside the following ranges:

Show all 21Show fewer

Systolic blood pressure <90 or >140 mmHg, or
Diastolic blood pressure <50 or >90 mmHg, or
Pulse <40 or >90 bpm
Prolonged QTcF (>450 ms), PR interval < 120 ms or > 240 ms, QRS>115 ms, clinically significant cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the Investigator.
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to C106.
Regular use of any prescribed or non-prescribed medication including antacids, analgesics, herbal remedies, vitamins and minerals within 2 weeks prior to the (first) administration of IMP, at the discretion of the Investigator.
Planned treatment or treatment with another investigational drug within 3 months prior to Day -1. Subjects consented and screened but not dosed in previous clinical trials are not excluded.
Current smokers or users of nicotine products. Irregular use of nicotine (e.g., smoking, snuffing, chewing tobacco) less than three times per week is allowed before screening visit.
Positive screen for drugs of abuse or alcohol at screening or on admission to the unit prior to administration of the IMP.
History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
Presence or history of drug abuse, as judged by the Investigator.
History of, or current use of, anabolic steroids.
Excessive caffeine consumption defined by a daily intake of >5 cups of caffeine containing beverages.
Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening.
Investigator considers the subject unlikely to comply with trial procedures, restrictions, and requirements.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

CTC Clinical Trial Consultants AB
Uppsala, SE-752 37

Other trials in Sweden

About this study

Official title: A Double-blind, Placebo-controlled, Randomised, First in Human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of C106 in Healthy Male and Female Subjects

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.

Conditions: Safety Issues, Tolerance, Idiopathic Pulmonary Fibrosis, Pulmonary Hypertension
Being tested: C106 solution, Placebo
Medical subject headings: Idiopathic Pulmonary Fibrosis, Hypertension, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

C106 solutionDrug
selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist
PlaceboDrug
Placebo for C106 solution

Study groups in NCT05427253
Study group	Role	What they receive
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 Receives: Drug: C106 solution
Placebo	Placebo comparator	Part A and B: Placebo to C106 without the active pharmaceutical ingredient Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Number of Treatment Emergent Adverse Events (AEs) and Serious AEs (SAEs)
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.
Measured: From date of signing informed consent until End of Study, assessed up to Day 22
Number of Reported Clinically Significant Changes From Baseline in 12-lead Electrocardiograms (ECGs)
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.
Measured: Part A: Up to Day 10. Part B: Up to Day 22.
Number of Reported Clinically Significant Changes in Vital Signs
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.
Measured: Part A: Up to Day 3, Part B: Up to Day 10. Vital signs were measured at pre-defined timepoints during the trial.
Number of Clinically Significant Changes in Laboratory Safety Variables (Haematology, Coagulation, Clinical Chemistry and Urine Analysis)
Blood samples for analysis of clinical chemistry, haematology, and coagulation parameters were collected through venepuncture or an indwelling venous catheter.
Measured: Part A: Up to Day 3, Part B: Up to Day 10. Safety laboratory samples were collected at pre-defined timepoints during the trial.
Number of Reported Clinically Significant Changes in Physical Examinations.
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.
.
Measured: Physical examination was performed at pre-defined timepoints during the trial. Part A: Day 7, Part B: Day 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jun 202222 Jun 2023

First posted22 Jun 2022
Study start8 Jun 2022
Primary completion22 Jun 2023
Study completion22 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Safety IssuesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: Part A, single ascending dose (SAD) including a food interaction cohort Part B, multiple ascending dose (MAD)
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05427253
Sponsor's protocol ID: VP-C106-101
Status last verified: Dec 2024
First submitted: 7 Jun 2022
Last updated: 31 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Placebo-controlled, Randomised, First in Human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of C106 in Healthy Male and Female Subjects
ClinicalTrials.gov ID: NCT05427253
Acronym / sponsor ID: VP-C106-101
Conditions: Safety Issues, Tolerance, Idiopathic Pulmonary Fibrosis, Pulmonary Hypertension
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Vicore Pharma ABIndustry (pharma, biotech, devices)
Study start: 8 Jun 2022 (actual)
Primary completion: 22 Jun 2023 (actual)
Study completion: 22 Jun 2023 (actual)
First posted: 22 Jun 2022 (actual)
Results: Posted 31 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The trial will be conducted in 2 parts:

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Part A, single ascending dose (SAD) including a food interaction cohort Part B, multiple ascending dose (MAD)

Arm	Type	Receives
C106 solution	Experimental	Drug: C106 solutionPart 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	Drug: PlaceboPart A and B: Placebo to C106 without the active pharmaceutical ingredient

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Willing and able to give written informed consent for participation in the trial.
Healthy males and females of non-childbearing potential aged 18-65 years inclusive.
Body Mass Index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2
Clinically normal medical history, physical findings, vital signs, ECG, and laboratory values at the time of screening, as judged by the Investigator
Women of non-childbearing potential, defined as pre-menopausal females who are sterilized (tubal ligation or permanent bilateral occlusion of fallopian tubes); or females who have undergone hysterectomy or bilateral oophorectomy; or post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with simultaneous detection of follicle stimulating hormone [FSH] ≥ 25 IU/L is confirmatory).

Key exclusion criteria (21 listed)

History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the trial, or influence the results or the subject's ability to participate in the trial.
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
Malignancy within the past 5 years except for in situ removal of basal cell carcinoma.
Any planned major surgery within the duration of the trial.
Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
C106 solutionselective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	Drug	C106 solution
PlaceboPlacebo for C106 solution	Drug	Placebo

Primary outcome

Total Number of Treatment Emergent Adverse Events (AEs) and Serious AEs (SAEs)
Time frame: 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 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.
Number of Reported Clinically Significant Changes From Baseline in 12-lead Electrocardiograms (ECGs)
Time frame: 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.
Number of Reported Clinically Significant Changes in Vital Signs
Time frame: 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.
Number of Clinically Significant Changes in Laboratory Safety Variables (Haematology, Coagulation, Clinical Chemistry and Urine Analysis)
Time frame: 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.
Number of Reported Clinically Significant Changes in Physical Examinations.
Time frame: 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. .

Results and safety

Results posted to the registry on 31 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SAD Part Cohort 1, Dose 5 mg	6	6
SAD Part Cohort 2, Dose 30 mg	6	6
SAD Part Cohort 3, Dose 60 mg	6	6
SAD Part Cohort 4, Dose 180 mg Fasted First, Then Dose 180 mg Fed	6	6
SAD Part Cohort 5, Dose 240 mg	6	6
SAD Part, Cohort 6, Dose 300 mg	6	6
SAD Part, Placebo	12	12
MAD Part, Dose 40mg	6	6
MAD Part, Dose 100mg	6	4
MAD Part, Dose 140mg	6	6
MAD Part, Dose 180mg	6	4
MAD Part, Placebo	8	8

Primary outcome: Total Number of Treatment Emergent Adverse Events (AEs) and Serious AEs (SAEs)

Time frame: From date of signing informed consent until End of Study, assessed up to Day 22. Number. Unit: Number of events

Measure	SAD Part Cohort 1, Dose 5 mg n = 6	SAD Part Cohort 2, Dose 30 mg n = 6	SAD Part Cohort 3, Dose 60 mg n = 6	SAD Part Cohort 4, Dose 180 mg n = 6	SAD Part Cohort 4, Dose 180 mg Fed n = 5	SAD Part Cohort 5, Dose 240 mg n = 6	SAD Part, Cohort 6, Dose 300 mg n = 6	SAD Part, Placebo n = 12	MAD Part, Dose 40mg n = 6	MAD Part, Dose 100mg n = 6	MAD Part, Dose 140mg n = 6	MAD Part, Dose 180mg n = 6	MAD Part, Placebo n = 8
Adverse events	5	5	3	2	2	7	8	4	11	10	15	7	21
Serious Adverse events	0	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: SAD: The withdrawn subject was part of Cohort 4 fed condition. .The subject was excluded from the trial before completing the food interaction visit. MAD: Two (2) subjects in the 100 mg C106 dose group had AEs (common cold) that lead to subject withdrawal from the trial.

Primary outcome: Number of Reported Clinically Significant Changes From Baseline in 12-lead Electrocardiograms (ECGs)

Time frame: Part A: Up to Day 10. Part B: Up to Day 22.. Number. Unit: Number of events

Measure	SAD Part Cohort 1, Dose 5 mg n = 6	SAD Part Cohort 2, Dose 30 mg n = 6	SAD Part Cohort 3, Dose 60 mg n = 6	SAD Part Cohort 4, Dose 180 mg n = 6	SAD Part Cohort 4, Dose 180 mg Fed n = 5	SAD Part Cohort 5, Dose 240 mg n = 6	SAD Part, Cohort 6, Dose 300 mg n = 6	SAD Part, Placebo n = 12	MAD Part, Dose 40mg n = 6	MAD Part, Dose 100mg n = 6	MAD Part, Dose 140mg n = 6	MAD Part, Dose 180mg n = 6	MAD Part, Placebo n = 8
Value	0	0	1	0	0	1	0	0	0	0	1	0	0

Population analysed: Data were presented using summary statistics..

Primary outcome: Number of Reported Clinically Significant Changes in Vital Signs

Time frame: Part A: Up to Day 3, Part B: Up to Day 10. Vital signs were measured at pre-defined timepoints during the trial.. Number. Unit: Number of events

Measure	SAD Part Cohort 5, Dose 240 mg n = 6	SAD Part, Cohort 6, Dose 300 mg n = 6	MAD Part, Dose 40mg n = 6	MAD Part, Dose 100mg n = 6	MAD Part, Dose 140mg n = 6	MAD Part, Dose 180mg n = 6	MAD Part, Placebo n = 8
Blood pressure	1	1	0	0	1	0	0
Pulse	0	0	0	0	0	0	0
Respiratory rate	0	0	2	1	0	1	2

Population analysed: Data were presented using summary statistics.

Primary outcome: Number of Clinically Significant Changes in Laboratory Safety Variables (Haematology, Coagulation, Clinical Chemistry and Urine Analysis)

Time frame: Part A: Up to Day 3, Part B: Up to Day 10. Safety laboratory samples were collected at pre-defined timepoints during the trial.. Number. Unit: Number of events

Measure	SAD Part Cohort 1, Dose 5 mg n = 6	SAD Part Cohort 2, Dose 30 mg n = 6	SAD Part Cohort 3, Dose 60 mg n = 6	SAD Part Cohort 4, Dose 180 mg n = 6	SAD Part Cohort 4, Dose 180 mg Fed n = 5	SAD Part Cohort 5, Dose 240 mg n = 6	SAD Part, Cohort 6, Dose 300 mg n = 6	SAD Part, Placebo n = 12	MAD Part, Dose 40mg n = 6	MAD Part, Dose 100mg n = 6	MAD Part, Dose 140mg n = 6	MAD Part, Dose 180mg n = 6	MAD Part, Placebo n = 8
Clinical chemistry	0	0	0	0	0	1	0	0	0	0	0	0	0
Haematology	0	0	0	0	0	0	0	0	0	0	0	0	0
Coagulation	0	0	0	0	0	0	0	0	0	0	0	0	0
Urinalysis	0	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: Data were presented using summary statistics.

Adverse events

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SAD Part Cohort 1, Dose 5 mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
SAD Part Cohort 2, Dose 30 mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
SAD Part Cohort 3, Dose 60 mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
SAD Part Cohort 4, Dose 180 mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
SAD Part Cohort 4, Dose 180 mg Fed	0 of 5 (0%)	2 of 5 (40%)	0 of 5
SAD Part Cohort 5, Dose 240 mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
SAD Part, Cohort 6, Dose 300 mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
SAD Part, Placebo	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12
MAD Part, Dose 40mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
MAD Part, Dose 100mg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
MAD Part, Dose 140mg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
MAD Part, Dose 180mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
MAD Part, Placebo	0 of 8 (0%)	8 of 8 (100%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Måns Jergil, PhD study director

CTC Clinical Trial Consultants AB (CTC)

Helena Litorp, MD, PhD principal investigator

CTC Clinical Trial Consultants AB (CTC)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing C106 solution in people with Safety Issues and Tolerance, run by Vicore Pharma AB at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Number of Treatment Emergent Adverse Events (AEs) and Serious AEs (SAEs) (time frame: From date of signing informed consent until End of Study, assessed up to Day 22). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05427253.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.