Phase1 First in Human Ascending Dose Study to Evaluate the Safety and Tolerability of FC-12738 in… (NCT05978908) | Clinical Trial Compass
CompletedPhase 1
Phase1 First in Human Ascending Dose Study to Evaluate the Safety and Tolerability of FC-12738 in Health Adults
United States24 participantsStarted 2024-02-20
Plain-language summary
A Phase I, Randomized, Double-Blind, Placebo-Controlled, First-in-human, Single-Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of retro enversio (RT) thymopentin in Healthy Adult Participants and Patients with Amyotrophic Lateral Sclerosis (ALS)
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Part A healthy males or females between the ages of 18 and 65 years of age and Part B males and females aged between 18 and 80 years of age, inclusive at the times of signing the informed consent;
✓. Female participants who:
✓. Able to give a signed written informed consent form (the informed consent form must be signed by the participant prior to any study-specific procedures); have a full understanding of the study content, procedures, and possible AEs; and be willing and able to comply with study procedures and follow-up examinations;
✓. Results of vital signs, physical examination, laboratory examinations, abdominal and Chest X-ray, 12-lead electrocardiogram (ECG), and other examination at Screening or Baseline are normal or abnormal but not clinically significant. Assessment may be repeated once if deemed appropriate by the investigator;
✓. Body mass index (BMI, weight \[kg\] / height2 \[m2\]) of 18 to 26 kg/m2, inclusively, with a minimum body weight of 50 kg for males, and 45 kg for females;
✓. Diagnosis of familial or sporadic ALS (defined as meeting the possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS ≤ 24 months prior to screening, according to the World Federation of Neurology El Escorial criteria published in 2000 ;
✓. Participants on riluzole or sodium phenylbutyrate/taurursodiol must be on a stable dose for at least 30 days prior to study enrollment; or patients on edaravone must have completed at least 2 cycles of dosing with edaravone at the time of screening or have not taken edaravone for at least 30 days prior to screening and not planning to start edaravone during the course of the study. Two cycles of dosing are defined as having completed Cycle 1 infusion, which is 14 consecutive days of intravenous (IV) edaravone followed by 14 days off edaravone, and Cycle 2, which is 10 out of 14 days of IV edaravone;
✓
What they're measuring
1
Characterize the safety/tolerability of single-ascending-dose study of FC-12738 in healthy adult participants
Timeframe: 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, post-dose and follow-up visit on Day 8.
2
Measure blood pressure with a blood pressue cuff
Timeframe: at screening, Day-1, pre-dose and 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, post-dose and follow-up visit on Day 8.
3
Heart rate measure
Timeframe: at screening, Day-1, pre-dose and 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, post-dose and follow-up visit on Day 8.
4
Physical exam signs by counting respiratory rate
Timeframe: at screening, Day-1, pre-dose and 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, post-dose and follow-up visit on Day 8.
5
Physical exam by temperature taken by a thermometer
Timeframe: at screening, Day-1, pre-dose and 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, post-dose and follow-up visit on Day 8.
6
Physical exam by 12 lead electrocardiogram
Timeframe: at screening, Day-1, pre-dose and 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, post-dose and follow-up visit on Day 8.
. Slow vital capacity (SVC) ≥ 60% of predicted within 1 month prior to Treatment Day 1.
Exclusion criteria
✕. Females who are pregnant, planning to become pregnant, or breastfeeding during the trial or within 3 months after the trial, or those with abnormal pregnancy test results that are clinically significant at Screening or Baseline (Day -1) as judged by the investigator;
✕. Has a positive alcohol test at Screening or the Baseline, or has a history of alcohol abuse;
✕. Participants who have been drinking excessive amounts of tea, coffee or caffeinated drinks (more than 8 cups a day, 1 cup =250 mL) per day within 3 months before Screening;
✕. Currently uses tobacco, nicotine or tobacco products, e-cigarettes or has stopped using tobacco products within the past 3 months and/or has a positive urine cotinine test at Screening or Baseline;
✕. Positive urine screening for drug abuse;
✕. Has received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month prior to the first dose of study drug, or plan to receive another experimental agent during the duration of this trial;
✕. Positive test result for active infectious diseases screening at Screening or Baseline, including human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C (HCV) antibody, and syphilis antibody (TP);
✕. Serious infection within 1 months before Screening or symptoms of infection during Screening period, including acute and chronic infections and local infections (bacterial, viral, parasitic, fungal, or other opportunistic pathogens), which is inappropriate to participant as deemed by the investigator;
Laboratory data will be measured by blood analysis
Timeframe: at screening, Day-1, pre-dose and 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, post-dose and follow-up visit on Day 8.
8
Laboratory data will be measured by serum biochemistry and urinalysis
Timeframe: at screening, Day-1, pre-dose and 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, post-dose and follow-up visit on Day 8.
9
Injection site reactions in normal participants
Timeframe: at screening, Day-1, pre-dose and 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, post-dose and follow-up visit on Day 8.