BridgeMD
Tests treatment safety and results for Chemotherapy-induced Peripheral Neuropathy (CIPN)
Official title Safety, Tolerability, and PK of AH-008 Following Single Ascending Dose in Healthy Subjects
ClinicalTrials.gov ID: NCT07697560
What this study is testing
What is AH-008 for Injection, 150 mg?
AH-008 for Injection, 150 mg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chemotherapy-induced peripheral neuropathy (cipn).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, parallel-group, single ascending dose (SAD) study to evaluate the safety, tolerability, and pharmacokinetics of AH-008 administered as a single intravenous infusion in healthy adult subjects. Four sequential dose cohorts will be evaluated, each with sentinel dosing and SRC-reviewed dose escalation.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Age range: 18 to 65 years.
- Body Mass Index (BMI) between 19 and 32 kg/m² (inclusive). Males: Body weight ≥ 50 kg; Females: Body weight ≥ 40 kg
- people understand and agree to comply with planned study procedures, can communicate well with the Investigator, understand the requirements of the...
- Subject is considered healthy, in the opinion of the Investigator, based on a detailed medical history, complete physical examination, vital signs...
- Female of non-childbearing potential (FONCBP) are considered inclusionary provided they meet one of the following criteria regarding non-childbearing...
You likely can't join if
- A history of any clinically serious illness, such as circulatory system, endocrine system, nervous system, digestive system, respiratory system...
- A history of autoimmune disease, spinal trauma, and various demyelinating diseases, including acute inflammatory demyelinating polyneuropathy...
- In the opinion of the investigator, A history of multiple episodes or severe allergies (e.g., food, drug allergy), or has had anaphylactic reaction...
- Human Immunodeficiency Virus-Antibody (HIV-Ab), Hepatitis B Surface Antigen (HBsAg) or Hepatitis C Virus-Antibody (HCV-Ab) serologically positive at...
- Surgery within 4 weeks prior to Screening or planned to have surgery during the trial period.
- Use of any prescription medicine, over-the-counter drug, herbal medicine, including herbal remedies such as St. John's wort, homeopathic and...
See the full eligibility criteria
- Age range: 18 to 65 years.
- Body Mass Index (BMI) between 19 and 32 kg/m² (inclusive). Males: Body weight ≥ 50 kg; Females: Body weight ≥ 40 kg
- people understand and agree to comply with planned study procedures, can communicate well with the Investigator, understand the requirements of the study, and have provided written informed consent.
- Subject is considered healthy, in the opinion of the Investigator, based on a detailed medical history, complete physical examination, vital signs, 12-lead ECG, and safety laboratory tests evaluation.
- Female of non-childbearing potential (FONCBP) are considered inclusionary provided they meet one of the following criteria regarding non-childbearing potential: (A) Permanently sterile: Permanent and irreversible...
- Male people are considered inclusionary provided they meet one of the following criteria regarding reproductive potential and partner status: (A) Partners of Non-Childbearing Potential: Male people with female partners...
- A history of any clinically serious illness, such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, renal, immunology, psychiatry, and metabolic abnormalities, or...
- A history of autoimmune disease, spinal trauma, and various demyelinating diseases, including acute inflammatory demyelinating polyneuropathy (Guillain-Barre syndrome).
- In the opinion of the investigator, A history of multiple episodes or severe allergies (e.g., food, drug allergy), or has had anaphylactic reaction or significant intolerance to prescription drugs, over-the-counter...
- Human Immunodeficiency Virus-Antibody (HIV-Ab), Hepatitis B Surface Antigen (HBsAg) or Hepatitis C Virus-Antibody (HCV-Ab) serologically positive at Screening.
- Surgery within 4 weeks prior to Screening or planned to have surgery during the trial period.
- Use of any prescription medicine, over-the-counter drug, herbal medicine, including herbal remedies such as St. John's wort, homeopathic and traditional medicines within 14 days or approximately 5 half-lives (whichever...
- Participation in any clinical trial and taking any investigational drug 30 days or approximately 5 half-lives (whichever is longer) before the first dosing.
- people who have donated or experienced loss of \>500 mL of whole blood within 90 days prior to Screening, or donated plasma within 14 days prior to Screening, or received a transfusion of blood or blood products within...
- Special dietary requirements or cannot follow a uniform diet during the trial period.
- Consumption of excessive amounts of tea, coffee, and/or caffeinated beverages per day (more than 8 cups, 1 cup = 250 mL) within 6 months prior to the first dosing and during the trial period.
- Positive breath test for alcohol at Screening or at admission, heavy drinkers or regular drinkers within 90 days prior to Screening, i.e., drinking more than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL...
- people who have smoked more than 5 cigarettes per day, used e-cigarettes or vaping products, or were unable to abstain from any tobacco or nicotine-containing products (including non-tobacco products such as nicotine...
- Drug abusers or those who had used soft drugs (e.g., marijuana) within 90 days prior to Screening or hard drugs (e.g., cocaine, phencyclidine, etc.) within 1 year prior to Screening, or who test positive for drugs at...
- people with resting vital signs outside the following reference ranges at Screening or Baseline, unless deemed not clinically significant by the Investigator: \ 140 mmHg, diastolic pressure \ 90 mmHg; Pulse beat \ 100...
- people with any clinically significant abnormality on 12-lead ECG or a QT interval corrected with the Fridericia formula (QTcF) \>450 milliseconds for females and \>430 milliseconds for males at Screening or Baseline.
- people with conditions that can potentially reduce drug clearance (eg, renal or hepatic insufficiency) at Screening or Baseline. A. Alanine Aminotransferase (ALT) \> 1.5 x ULN B. Aspartate Aminotransferase (AST) \> 1.5...
- people with significant bleeding or clotting diathesis, as judged by the investigator, that may interfere with venous blood collection or intravenous infusion.
- For females of childbearing potential (FOCBP): unwillingness to use a highly effective contraceptive method (method of birth control which result in a low failure rate (i.e. less than 1% per year) when used consistently...
- For male people who are not surgically sterile (vasectomy) for at least 3 months prior to dosing and who are sexually active with a female partner of childbearing potential (childbearing potential females are defined as...
- people may not be able to complete the study for other reasons or should not be included in the study as determined by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Salt Lake City, Utah, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.