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

NCT ID: NCT05427253

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-08
• Study Completion Date: 2023-06-22

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

C106 solution

Part A: Oral administration start dose, Single dose 5 mg Part B: Oral administration start dose 20 mg twice daily for 8 days

Group Type: EXPERIMENTAL

C106 solution

Intervention Type: DRUG

selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist

Placebo

Part A and B: Placebo to C106 without the active pharmaceutical ingredient

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo for C106 solution

Interventions

C106 solution

selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist

Intervention Type: DRUG

Placebo

Placebo for C106 solution

Intervention Type: DRUG

Eligibility Criteria

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, vital signs, ECG, and laboratory values at the time of screening, as judged by the Investigator

5. 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.

Exclusion Criteria

1. 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.

2. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.

3. Malignancy within the past 5 years except for in situ removal of basal cell carcinoma.

4. Any planned major surgery within the duration of the trial.

5. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV).

6. After 10 minutes supine rest at the time of screening, any vital signs values outside the following ranges:

• Systolic blood pressure <90 or >140 mmHg, or
• Diastolic blood pressure <50 or >90 mmHg, or
• Pulse <40 or >90 bpm

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. Positive screen for drugs of abuse or alcohol at screening or on admission to the unit prior to administration of the IMP.

13. History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.

14. Presence or history of drug abuse, as judged by the Investigator.

15. History of, or current use of, anabolic steroids.

16. Excessive caffeine consumption defined by a daily intake of >5 cups of caffeine containing beverages.

17. Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening.

18. Investigator considers the subject unlikely to comply with trial procedures, restrictions, and requirements.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vicore Pharma AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Måns Jergil, PhD

Role: STUDY_DIRECTOR

CTC Clinical Trial Consultants AB (CTC)

Helena Litorp, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CTC Clinical Trial Consultants AB (CTC)

Locations

CTC Clinical Trial Consultants AB

Uppsala, , Sweden

Countries

Sweden

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

VP-C106-101

Identifier Type: -

Identifier Source: org_study_id