Phase 1 Study of HS-20152 in Healthy Participants
ConditionHealthy Volunteers
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-64
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.
About this trial
This first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study will evaluate the safety and tolerability of HS-20152, an investigational therapy targeting the complement pathway, in healthy adults. Secondary objectives include characterization of pharmacokinetics and pharmacodynamic effects on complement-related biomarkers.
Eligibility criteria
Qualifiers
Males or females aged 18 to 64 years (inclusive) when signing the ICF.
Body Mass Index (BMI = weight/height²) ≥ 19 kg/m² and ≤ 28 kg/m² at screening, and males must weigh ≥50 kg, and females must weigh ≥ 45 kg.
Female participants must agree to practice highly effective contraception from 2 weeks prior to screening until 6 months after dosing.
Male participants with childbearing potential must agree to practice highly effective contraception from the date of signing the ICF until 6 months after dosing; male participants without childbearing potential (e.g, having undergone effective sterilization) must agree to use additional highly effective contraception if there is any uncertainty about the presence of sperm.
Disqualifiers
Consumption of any caffeine, tea, alcohol, xanthine-rich foods or beverages within 24 hours before dosing.
Consumption of red wine, citrus fruits (such as grapefruit, oranges, tangerines, etc.), grapes, mangoes, or star fruits, or juices containing these fruits, within 72 hours prior to dosing.
Abnormal and clinically significant results in vital signs, physical examination, laboratory tests, 12-lead ECG, chest X-ray (anteroposterior and lateral)/CT, or abdominal ultrasound at screening, which, in the investigator's judgement, may increase the participant's risk in the study or affect the interpretation of the study results.
Positive for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), HCV Ab, HIV antibody, or syphilis-specific antibodies at screening.
Trial design
Treatments tested in this trial
- HS-20152
- Placebo
Treatment groups
32 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov