AH-008 for Peripheral Neuropathy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety of a new treatment, AH-008 for Injection, to observe its behavior in the body when administered through an IV. Researchers aim to understand its potential use for peripheral neuropathy, a condition causing numbness or pain in the hands and feet. Participants will receive either the actual treatment or a placebo (a harmless, inactive substance) to compare results. The trial seeks healthy adults who can follow study procedures and have not experienced major health issues or surgeries recently. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Is there any evidence suggesting that AH-008 for Injection is likely to be safe for humans?
Research shows that AH-008 is currently undergoing safety testing in healthy adults. This marks the first time AH-008 has been tested on humans. The trial aims to assess tolerability and identify any side effects.
As an early-stage trial, limited information exists on AH-008's safety profile. Such trials primarily ensure the treatment's safety for humans. Participation in a Phase 1 trial indicates that safety evidence is still being collected.
In the study, researchers administer AH-008 in increasing doses to observe the body's reactions. This careful approach helps identify potential issues early. The trial is closely monitored, with safety as a top priority.12345Why do researchers think this study treatment might be promising for peripheral neuropathy?
Most treatments for peripheral neuropathy aim to relieve symptoms using oral medications like gabapentin or pregabalin, which modulate nerve signals. However, AH-008 is unique because it is administered as a single IV infusion, potentially offering a more direct and fast-acting approach. Researchers are excited about AH-008 because it involves escalating doses across different patient groups, offering a chance to fine-tune its effectiveness and safety profile. This innovative delivery method and dosing strategy might provide quicker relief compared to traditional oral medications.
What evidence suggests that AH-008 might be an effective treatment for peripheral neuropathy?
Research shows that AH-008, which participants in this trial may receive, is designed to protect nerves from chemotherapy-induced damage. Studies have demonstrated its strong protective effects on nerves in models of chemotherapy-related nerve damage. This means it helps maintain nerve function and prevents lasting harm. Although direct evidence on its effects in humans is not yet available, this promising approach suggests AH-008 could help reduce nerve pain and damage in these situations.13678
Are You a Good Fit for This Trial?
This trial is for healthy adults who do not have any serious medical conditions. Participants should not be taking medications or have a history of drug allergies, and must meet other health requirements set by the study team.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intravenous infusion of AH-008 or placebo with dose escalation across 4 cohorts
Follow-up
Participants are monitored for safety and pharmacokinetics from baseline through 48 hours after dosing
What Are the Treatments Tested in This Trial?
Interventions
- AH-008 for Injection
Trial Overview
The study is testing different single doses of a new drug called AH-008, given through an IV infusion, to see how safe it is and how the body processes it. Some participants will get AH-008 while others receive a placebo. The trial uses random assignment and blinding.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Single IV infusion at escalating doses across 4 sequential cohorts
Matching placebo IV infusion with no active ingredient
Find a Clinic Near You
Who Is Running the Clinical Trial?
AnHorn Medicines Co. Ltd.
Lead Sponsor
Citations
AH-008 Achieves Key Clinical Milestone with Successful ...
Studies indicate that 60–70% of patients experience CIPN during or shortly after chemotherapy, and nearly one-third continue to suffer six months or longer ...
Safety, Tolerability, and PK of AH-008 Following Single ...
This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, parallel-group, single ascending dose (SAD) study to ...
AH-008 Achieves Key Clinical Milestone with Successful ...
AH-008 is a novel neuroprotective drug candidate designed to prevent chemotherapy-induced nerve damage before irreversible neuropathy develops.
AH-008 Achieves Dual Regulatory Milestones with U.S. ...
AH-008 consistently demonstrated robust neuroprotective effects across multiple chemotherapy-induced neuropathy models, preserving peripheral ...
Evolving Treatment Strategies for Neuropathic Pain - PMC - NIH
Clinical trials and longitudinal studies have demonstrated significant reductions in pain intensity and improvements in quality of life … ...
AH-008 Achieves Key Clinical Milestone with Successful ...
The Phase I clinical trial is designed to evaluate the safety, tolerability, and pharmacokinetics of AH-008 in healthy volunteers. The data ...
7.
ddw-online.com
ddw-online.com/phase-i-study-for-prevention-of-chemotherapy-induced-peripheral-neuropathy-43153-202607/Phase I study for prevention of chemotherapy-induced ...
AH-008, a first-in-class neuroprotective candidate being developed to prevent chemotherapy-induced peripheral neuropathy (CIPN).
Efficacy and Safety of the Injection of the Traditional Chinese ...
This meta-analysis demonstrated that puerarin injection may be more effective and safe for the treatment of DPN.
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