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

NCT05978908 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-05-25

No results posted yet for this study

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)

Conditions

  • Safety Issues
  • Tolerance

Interventions

DRUG

FC-12738

Retro enversio pentapeptide of thymopentin

DRUG

Saline

placebo

Sponsors & Collaborators

  • Neurodegenerative Disease Research Inc

    lead OTHER

Principal Investigators

  • Lisa Busco · Rho Worldwide

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-20
Primary Completion
2024-06-03
Completion
2024-06-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05978908 on ClinicalTrials.gov