Safety, Tolerability, and PK of AH-008 Following Single Ascending Dose in Healthy Subjects

NCT07697560 | Recruiting Phase 1 FDA Drug

• 1 other identifier: AH-008-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy (CIPN)

Keywords

Prevention of Chemotherapy-Induced Peripheral Neuropathy;; AH-008; CIPN

Outcome Measures

Primary Outcomes (11)

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  Number of subjects experiencing one or more treatment-emergent adverse events, assessed according to MedDRA coding and investigator assessment.

  From Baseline (Day -1) through Day 3 (48 hours after dosing)

• Incidence of Clinically Significant Vital Sign Abnormalities

  Number of subjects with clinically significant abnormalities in vital signs (blood pressure, heart rate, respiratory rate, and body temperature)

  From Baseline (Day -1) through Day 3 (48 hours after dosing)

• Incidence of Clinically Significant 12-Lead ECG Abnormalities

  Assessment includes PR interval, QRS duration, QT interval, QTcF interval, heart rate, rhythm.

  From Baseline (Day -1) through Day 3 (48 hours after dosing)

• Incidence of Clinically Significant Clinical Laboratory Abnormalities

  Clinical laboratory assessments include hematology, serum chemistry and urinalysis parameters. Laboratory abnormalities will be evaluated by the investigator for clinical significance.

  From Baseline (Day -1) through Day 3 (48 hours after dosing)

• Incidence of Subjects with Infusion Site Reactions

  Number and percentage of subjects experiencing infusion site reactions following administration of AH-008.

  From Baseline (Day -1) through Day 3 (48 hours after dosing)

• Pharmacokinetic characterization of maximum observed plasma concentration (Cmax) of AH-008

  Maximum observed plasma concentration of AH-008 following a single intravenous administration.

  From Baseline (Day -1) through Day 3 (48 hours after dosing)

• Pharmacokinetic characterization of time to maximum observed plasma concentration (Tmax) of AH-008

  Time to reach the maximum observed plasma concentration of AH-008 following a single intravenous administration.

  From Baseline (Day -1) through Day 3 (48 hours after dosing)

• Pharmacokinetic characterization of area under the plasma concentration-time curve (AUC) of AH-008

  Area under the plasma concentration-time curve of AH-008 following a single intravenous administration.

  From Baseline (Day -1) through Day 3 (48 hours after dosing)

• Pharmacokinetic characterization of terminal elimination half-life (t½) of AH-008

  Terminal elimination half-life of AH-008 calculated from plasma concentration-time data following a single intravenous administration.

  From Baseline (Day -1) through Day 3 (48 hours after dosing)

• Pharmacokinetic characterization of cumulative amount of AH-008 excreted in urine (Ae0-t)

  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.

  From Baseline (Day -1) through Day 3 (48 hours after dosing)

• Pharmacokinetic characterization of urine recovery rate of AH-008 (Ae%)

  The percentage of administered AH-008 dose recovered unchanged in urine following a single intravenous administration will be determined.

  From Baseline (Day -1) through Day 3 (48 hours after dosing)

Study Arms (2)

Experimental: AH-008

EXPERIMENTAL

Single IV infusion at escalating doses across 4 sequential cohorts

Drug: AH-008 for Injection, 150 mg

Matching placebo

PLACEBO COMPARATOR

Matching placebo IV infusion with no active ingredient

Drug: AH-008 for Injection, Placebo

Interventions

AH-008 for Injection, 150 mg DRUG

Lyophilized powder

Experimental: AH-008

AH-008 for Injection, Placebo DRUG

Lyophilized powder

Matching placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• Subjects 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.
• (A) Permanently sterile: Permanent and irreversible infertility via documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
• (B) Postmenopausal: Defined as 12 months of spontaneous amenorrhea. In questionable cases, a blood test with Follicle Stimulating Hormone (FSH) levels \>40 mIU/mL at Screening will be used to confirm postmenopausal status.
• (A) Partners of Non-Childbearing Potential: Male subjects with female partners of non-childbearing potential (defined as surgically sterile via hysterectomy, bilateral salpingectomy, or bilateral oophorectomy; or confirmed postmenopausal for at least 12 months) are eligible and are not required to use additional contraception.
• (B) Partners Using Effective Contraception: Male subjects with female partners of childbearing potential who are already utilizing a highly effective contraceptive method (failure rate of \<1% per year) are eligible and are not required to use condoms or other barriers, unless the partner is currently pregnant. (C) Vasectomized Males: Males who have undergone a successful vasectomy (at least 3 months prior to dosing) are eligible without further contraceptive requirements.

You may not qualify if:

• 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 any other disease or physiological condition that, in the investigator's judgment may interfere with test results or pose an undue safety risk.
• 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 drugs or foods.
• 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 is longer) before the first dosing during the trial period, except for paracetamol/acetaminophen, ibuprofen, and hormonal contraceptives.
• Participation in any clinical trial and taking any investigational drug 30 days or approximately 5 half-lives (whichever is longer) before the first dosing.
• Subjects 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 90 days prior to Screening.
• 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 40% spirits or 150 mL wine), or unable to stop using any alcoholic products during the trial period.
• Subjects 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 patches, gum, or lozenges) in the 90 days prior to Screening and throughout the study.
• 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 Screening or Baseline, will be excluded.
• Subjects with resting vital signs outside the following reference ranges at Screening or Baseline, unless deemed not clinically significant by the Investigator: \<90 mmHg or \>140 mmHg, diastolic pressure \<50 mmHg or \>90 mmHg; Pulse beat \<50 BPM or \>100 BPM, respiration \<12 times/minute or \>20 times/minute.
• Subjects 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.

Sponsors & Collaborators

• AnHorn Medicines Co. Ltd.: lead

Study Sites (1)

ICON Clinial Research Unit

Salt Lake City, Utah, 84124, United States

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 13, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)