Safety Issues Clinical Trial
Official title:
FC-12738 Single Ascending Dose in Health Adult and Patients With ALS
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)
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). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04485481 -
Single and Multiple Ascending Dose Study of ADX-914 in Healthy Adult Volunteers
|
Phase 1 | |
| Completed |
NCT03473236 -
Phase 1A Safety Trial of Inhaled PK10571 (GB002)
|
Phase 1 | |
| Not yet recruiting |
NCT03683953 -
The Treatment of Bronchopulmonary Dysplasia by Intratracheal Instillation of Mesenchymal Stem Cells
|
Phase 1 | |
| Recruiting |
NCT05546567 -
NOPARK Open Label Extension Study
|
N/A | |
| Recruiting |
NCT05413226 -
Effect of Different Ingestion Doses of Celastrol on Human Sperm Motility
|
N/A | |
| Recruiting |
NCT05112159 -
Study of IPG1094 in Healthy Participants
|
Phase 1 | |
| Completed |
NCT04689035 -
A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144
|
Phase 1 | |
| Completed |
NCT04335045 -
Phase I Study of PH100 (Ecklonia Cava Phlorotannins)
|
Phase 1 | |
| Completed |
NCT05037227 -
Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia
|
||
| Recruiting |
NCT05517291 -
DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease
|
N/A | |
| Enrolling by invitation |
NCT06446778 -
Haemodynamic Mechanisms and Multicentre Prospective Cohort Study of the Pipeline Flow-diverting Device for the Treatment of Intracranial Aneurysms. Evaluation of the Safety and Efficacy of the Pipeline Flow-diverting Device for the Treatment of Intracranial Aneurysms
|
||
| Recruiting |
NCT04573049 -
The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement
|
Phase 4 | |
| Completed |
NCT05585463 -
Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study (ACUSAFE2021)
|
||
| Completed |
NCT04188821 -
Reduction of Seroma and Improvement of QoL in Breast Reconstruction With Tissue Expander
|
N/A | |
| Completed |
NCT03667430 -
Safety Evaluation of Porous Silica in Men
|
N/A | |
| Completed |
NCT04499482 -
Safety and Tolerability of Soy Fiber
|
N/A | |
| Completed |
NCT03141905 -
Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease
|
N/A | |
| Completed |
NCT05244161 -
A Quasi-experimental Evaluation of the Malezi Program in Tanzania
|
N/A | |
| Recruiting |
NCT03791372 -
Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Cerebral Palsy
|
Phase 1 | |
| Not yet recruiting |
NCT04774900 -
Standardization of Ambulance Equipment
|