Safety, Tolerability, and PK of AH-008 Following Single Ascending Dose in Healthy Subjects (NCT07697560) | Clinical Trial Compass
RecruitingPhase 1
Safety, Tolerability, and PK of AH-008 Following Single Ascending Dose in Healthy Subjects
United States32 participantsStarted 2026-06-10
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
. 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:
. Male subjects are considered inclusionary provided they meet one of the following criteria regarding reproductive potential and partner status:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Timeframe: From Baseline (Day -1) through Day 3 (48 hours after dosing)
2
Incidence of Clinically Significant Vital Sign Abnormalities
Timeframe: From Baseline (Day -1) through Day 3 (48 hours after dosing)
3
Incidence of Clinically Significant 12-Lead ECG Abnormalities
Timeframe: From Baseline (Day -1) through Day 3 (48 hours after dosing)
4
Incidence of Clinically Significant Clinical Laboratory Abnormalities
Timeframe: From Baseline (Day -1) through Day 3 (48 hours after dosing)
5
Incidence of Subjects with Infusion Site Reactions
Timeframe: From Baseline (Day -1) through Day 3 (48 hours after dosing)
6
Pharmacokinetic characterization of maximum observed plasma concentration (Cmax) of AH-008
Timeframe: From Baseline (Day -1) through Day 3 (48 hours after dosing)
. 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.
Pharmacokinetic characterization of time to maximum observed plasma concentration (Tmax) of AH-008
Timeframe: From Baseline (Day -1) through Day 3 (48 hours after dosing)
8
Pharmacokinetic characterization of area under the plasma concentration-time curve (AUC) of AH-008
Timeframe: From Baseline (Day -1) through Day 3 (48 hours after dosing)
9
Pharmacokinetic characterization of terminal elimination half-life (t½) of AH-008
Timeframe: From Baseline (Day -1) through Day 3 (48 hours after dosing)
10
Pharmacokinetic characterization of cumulative amount of AH-008 excreted in urine (Ae0-t)
Timeframe: From Baseline (Day -1) through Day 3 (48 hours after dosing)
11
Pharmacokinetic characterization of urine recovery rate of AH-008 (Ae%)
Timeframe: From Baseline (Day -1) through Day 3 (48 hours after dosing)