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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
AH-008 for Injection, 150 mg
DrugLyophilized powder
AH-008 for Injection, Placebo
DrugLyophilized powder
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Experimental: AH-008Experimental treatment 1 intervention
Group B: Matching placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From Baseline (Day -1) through Day 3 (48 hours after dosing)2
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)
Time frame
From Baseline (Day -1) through Day 3 (48 hours after dosing)3
Incidence of Clinically Significant 12-Lead ECG Abnormalities
Assessment includes PR interval, QRS duration, QT interval, QTcF interval, heart rate, rhythm.
Time frame
From Baseline (Day -1) through Day 3 (48 hours after dosing)4
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.
Time frame
From Baseline (Day -1) through Day 3 (48 hours after dosing)Sponsors and contacts
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Source ClinicalTrials.gov