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Phase1 First in Human Ascending Dose Study to Evaluate the Safety and Tolerability of FC-12738 in Health Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Phase1 First in Human Ascending Dose Study to Evaluate the Safety and Tolerability of FC-12738 in Health Adults

FC-12738 Single Ascending Dose in Health Adult and Patients With ALS

NCT05978908•Neurodegenerative Disease Research Inc

View on ClinicalTrials.gov

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)

Detailed Description

This is a first-in-human, randomized, double-blind, placebo-controlled, single-ascending-dose (SAD) study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of retro enversio thymopentin (FC-12738) in healthy adult participants and patients with ALS. The clinical trial will be conducted in two parts, initially a SAD study in 3-sequential cohorts of healthy adult participants (PartA), and then follows another SAD study in 4-6-sequential cohorts of patients with ALS (Part B). Dose escalation in the SAD cohorts will be determined after having reviewed of the interim safety data as well as all available PK and/or PD data from the preceding dose level(s).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. 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;
•2. Female participants who:
•Are postmenopausal (over or equal to 1 year), OR Are surgically sterile, confirmed by medical documentations, OR If they are of child bearing potential, agree to use at least 1 highly effective method of contraception and 1 additional effective method at the same time, from at least 1 month prior to the initiation of the study through 3 months after the last administration. OR Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant; Agree to refrain from egg donation and in vitro fertilization during the entire study period and through 90 days after the last dose of study drug;
•Male participants, even if surgically sterilized (i.e., status postvasectomy), who:
•Agree to practice effective barrier contraception and avoid sperm donation during the entire study period and through 90 days after the last dose of study drug, OR Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant;
•3. 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;
•4. 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;
•5. 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;
•6. 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 ;
•7. 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;
+1 more criteria

Exclusion Criteria

•1. 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;
•2. Has a positive alcohol test at Screening or the Baseline, or has a history of alcohol abuse;
•3. 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;
•4. 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;
•5. Positive urine screening for drug abuse;
•6. 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;
•7. 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);
•8. 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;
•9. Blood loss of non-physiological reasons ≥ 400 mL (i.e., trauma, blood collection, blood donation) within 2 months prior to the first dose of study drug, or plan to donate blood during this trial and within 1 month after the last dosing;
•10. Except as noted, has used any over-the-counter medications, prescription drugs (other than hormone replacement therapy), nutritional supplements, or herbal medicines unless, in the opinion of the investigator and sponsor, the drug will not interfere with study assessments;
+12 more criteria

Locations (1)

Hassman Research Inc

Berlin, New Jersey, United States

Key Dates

Start Date

February 20, 2024

Primary Completion Date

June 3, 2024

Completion Date

June 28, 2024

Last Updated

May 25, 2025

Enrollment

ACTUAL participants

Conditions

Safety IssuesTolerance

Interventions

FC-12738

DRUG

Saline

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase1 First in Human Ascending Dose Study to Evaluate the Safety and Tolerability of FC-12738 in Health Adults

Inclusion Criteria

Exclusion Criteria

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