AH-008 for Chemotherapy-induced Peripheral Neuropathy
This study is testing a new medication called AH-008 for injection, or a placebo (an inactive substance), to see how safe it is and how your body handles it. This is a first-time-in-human study, meaning it's the first time AH-008 is being given to people. We are looking for healthy adults between 18 and 65 years old to participate. The main goal is to track any side effects and changes in your vital signs (like blood pressure and heart rate) and heart rhythm for about three days after you receive the medication. The study plans to enroll 32 participants, but the current recruitment status is unclear.
- Study design
- This is a Phase 1, randomized, double-blind study, meaning participants are randomly assigned to receive either AH-008 or a placebo, and neither you nor the study staff will know which you receive. It involves a single dose given to a small group of healthy adults.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for at least 48 hours after receiving the study medication to monitor for side effects and changes in your vital signs and heart rhythm.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety, Tolerability, and PK of AH-008 Following Single Ascending Dose in Healthy Subjects
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Incidence of Treatment-Emergent Adverse Events (TEAEs)From Baseline (Day -1) through Day 3 (48 hours after dosing)
Number of subjects experiencing one or more treatment-emergent adverse events, assessed according to MedDRA coding and investigator assessment.
- Incidence of Clinically Significant Vital Sign AbnormalitiesFrom Baseline (Day -1) through Day 3 (48 hours after dosing)
Number of subjects with clinically significant abnormalities in vital signs (blood pressure, heart rate, respiratory rate, and body temperature)
- Incidence of Clinically Significant 12-Lead ECG AbnormalitiesFrom Baseline (Day -1) through Day 3 (48 hours after dosing)
Assessment includes PR interval, QRS duration, QT interval, QTcF interval, heart rate, rhythm.
- Incidence of Clinically Significant Clinical Laboratory AbnormalitiesFrom Baseline (Day -1) through Day 3 (48 hours after dosing)
Clinical laboratory assessments include hematology, serum chemistry and urinalysis parameters. Laboratory abnormalities will be evaluated by the investigator for clinical significance.
- Incidence of Subjects with Infusion Site ReactionsFrom Baseline (Day -1) through Day 3 (48 hours after dosing)
Number and percentage of subjects experiencing infusion site reactions following administration of AH-008.
- Pharmacokinetic characterization of maximum observed plasma concentration (Cmax) of AH-008From Baseline (Day -1) through Day 3 (48 hours after dosing)
Maximum observed plasma concentration of AH-008 following a single intravenous administration.
- Pharmacokinetic characterization of time to maximum observed plasma concentration (Tmax) of AH-008From Baseline (Day -1) through Day 3 (48 hours after dosing)
Time to reach the maximum observed plasma concentration of AH-008 following a single intravenous administration.
- Pharmacokinetic characterization of area under the plasma concentration-time curve (AUC) of AH-008From Baseline (Day -1) through Day 3 (48 hours after dosing)
Area under the plasma concentration-time curve of AH-008 following a single intravenous administration.
- Pharmacokinetic characterization of terminal elimination half-life (t½) of AH-008From Baseline (Day -1) through Day 3 (48 hours after dosing)
Terminal elimination half-life of AH-008 calculated from plasma concentration-time data following a single intravenous administration.
- Pharmacokinetic characterization of cumulative amount of AH-008 excreted in urine (Ae0-t)From Baseline (Day -1) through Day 3 (48 hours after dosing)
Based on individual urine concentration-time data collected using actual sampling times, the cumulative amount of unchanged AH-008 excreted in urine from time zero to the last measurable collection interval (Ae0-t) following a single intravenous administration will be determined.
- Pharmacokinetic characterization of urine recovery rate of AH-008 (Ae%)From Baseline (Day -1) through Day 3 (48 hours after dosing)
The percentage of administered AH-008 dose recovered unchanged in urine following a single intravenous administration will be determined.