First-in-human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of C106 in Healthy… (NCT05427253) | Clinical Trial Compass
CompletedPhase 1
First-in-human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of C106 in Healthy Subjects
Sweden80 participantsStarted 2022-06-08
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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).
Exclusion criteria
✕. 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.
What they're measuring
1
Total Number of Treatment Emergent Adverse Events (AEs) and Serious AEs (SAEs)
Timeframe: From date of signing informed consent until End of Study, assessed up to Day 22
2
Number of Reported Clinically Significant Changes From Baseline in 12-lead Electrocardiograms (ECGs)
Timeframe: Part A: Up to Day 10. Part B: Up to Day 22.
3
Number of Reported Clinically Significant Changes in Vital Signs
Timeframe: Part A: Up to Day 3, Part B: Up to Day 10. Vital signs were measured at pre-defined timepoints during the trial.
4
Number of Clinically Significant Changes in Laboratory Safety Variables (Haematology, Coagulation, Clinical Chemistry and Urine Analysis)
Timeframe: Part A: Up to Day 3, Part B: Up to Day 10. Safety laboratory samples were collected at pre-defined timepoints during the trial.
5
Number of Reported Clinically Significant Changes in Physical Examinations.
Timeframe: Physical examination was performed at pre-defined timepoints during the trial. Part A: Day 7, Part B: Day 22
✕. 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:
✕. 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.