Safety, Tolerability, and PK of AH-008 Following Single Ascending Dose in Healthy Subjects
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAnHorn Medicines Co. Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- AH-008 for Injection, 150 mg
- AH-008 for Injection, Placebo
Treatment groups
32 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov