Chemotherapy-induced Peripheral Neuropathy (CIPN)Phase 1NCT07697560
Safety, Tolerability, and PK of AH-008 Following Single Ascending Dose in Healthy Subjects
A Phase 1 study testing AH-008 for Injection, 150 mg in people with Chemotherapy-induced Peripheral Neuropathy (CIPN), run by AnHorn Medicines Co. Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy (CIPN)
- What is being tested?
- AH-008 for Injection, 150 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2026to 25 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Female of non-childbearing potential (FONCBP) are considered inclusionary provided they meet one of the following criteria regarding non-childbearing potential:
- Permanently sterile: Permanent and irreversible infertility via documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
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- 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.
- Male subjects are considered inclusionary provided they meet one of the following criteria regarding reproductive potential and partner status:
- 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.
- 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.
Who cannot join
- 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.
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- 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.
- Subjects with conditions that can potentially reduce drug clearance (eg, renal or hepatic insufficiency) at Screening or Baseline.
- Alanine Aminotransferase (ALT) > 1.5 x ULN B. Aspartate Aminotransferase (AST) > 1.5 x ULN C. Alkaline phosphatase (ALP) > ULN D. Glomerular filtration rate (GFR) < 80 mL/min/1.73 m² as calculated by the CKD-EPI equation.
- E.Total Protein (TP) > ULN F. Total Bilirubin (TBIL) > 1.2 x ULN G. Gamma-Glutamyl Transferase > ULN H. Lactate Dehydrogenase (LDH) > ULN I. International Normalized Ratio (INR) > 1.5 x ULN
- Subjects 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 and correctly such as implants, injectables, combined oral contraceptives, non-hormonal or hormonal intrauterine devices (IUDs), sexual abstinence or vasectomized partner) during sexual intercourse with a partner of childbearing potential throughout the trial and for 30 days after last dose.
- For male subjects 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 women that are neither post-menopausal nor surgically sterile): unwillingness to simultaneously use a condom and a highly effective contraceptive method, as mentioned above, for the female partner throughout the trial and for 30 days after the last dose.
- Subjects may not be able to complete the study for other reasons or should not be included in the study as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
ICON Clinial Research Unit
Salt Lake City, Utah, 84124
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AH-008 Following Single Ascending Dose Administration in Healthy Subjects
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.
- Being tested
- AH-008 for Injection, 150 mg, AH-008 for Injection, Placebo
- Keywords
- Prevention of Chemotherapy-Induced Peripheral Neuropathy;, AH-008, CIPN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AH-008 for Injection, 150 mgDrug
Lyophilized powder
AH-008 for Injection, PlaceboDrug
Lyophilized powder
| Study group | Role | What they receive |
|---|---|---|
| Experimental: AH-008 | Experimental | Single IV infusion at escalating doses across 4 sequential cohorts Receives: Drug: AH-008 for Injection, 150 mg |
| Matching placebo | Placebo comparator | Matching placebo IV infusion with no active ingredient Receives: Drug: AH-008 for Injection, Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Baseline (Day -1) through Day 3 (48 hours after dosing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start10 Jun 2026
- Primary completion25 Sep 2026
- Study completion25 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral Neuropathy (CIPN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- AnHorn Medicines Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697560
- Sponsor's protocol ID
- AH-008-01
- Status last verified
- Oct 2026
- First submitted
- 30 Jun 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AH-008 Following Single Ascending Dose Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07697560
- Acronym / sponsor ID
- AH-008-01
- Keywords
- Prevention of Chemotherapy-Induced Peripheral Neuropathy;, AH-008, CIPN
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- AnHorn Medicines Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 25 Sep 2026 (actual)
- Study completion
- 25 Sep 2026 (actual)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: AH-008 | Experimental | Drug: AH-008 for Injection, 150 mgSingle IV infusion at escalating doses across 4 sequential cohorts |
| Matching placebo | Placebo comparator | Drug: AH-008 for Injection, PlaceboMatching placebo IV infusion with no active ingredient |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Female of non-childbearing potential (FONCBP) are considered inclusionary provided they meet one of the following criteria regarding non-childbearing potential:
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AH-008 for Injection, 150 mgLyophilized powder | Drug | Experimental: AH-008 |
| AH-008 for Injection, PlaceboLyophilized powder | Drug | Matching placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: 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 Abnormalities
Time frame: From 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 Abnormalities
Time frame: From 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 Abnormalities
Time frame: From 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 Reactions
Time frame: From 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-008
Time frame: From 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-008
Time frame: From 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-008
Time frame: From 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-008
Time frame: From 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)
Time frame: 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%)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AH-008 for Injection, 150 mg in people with Chemotherapy-induced Peripheral Neuropathy (CIPN), run by AnHorn Medicines Co. Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (TEAEs) (time frame: From Baseline (Day -1) through Day 3 (48 hours after dosing)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.