Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • HS-20152

    Drug

    HS-20152: HS-20152 will be administrated as a single dose in four sequential dose cohorts with ascending dose levels (Low, Mid, High, and an optional alternative dose cohort)

  • Placebo

    Drug

    Placebo: Placebo matched to HS-20152 will be administrated as a single dose in each cohort, including the optional alternative dose if implemented.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: HS-20152Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of adverse events and/or serious adverse events of a single-dose of HS-20152

Time frame
Up to 24 weeks

Secondary outcomes

1

Maximum observed plasma concentration (Cmax) of HS-20152

Pharmacokinetic parameters of HS-20152 in plasma following a single dose

Time frame
Up to 24 weeks
2

Time to maximum concentration (Tmax) of HS-20152

Pharmacokinetic parameters of HS-20152 in plasma following a single dose

Time frame
Up to 24 weeks
3

Area under the plasma concentration-time curve from time 0 to last quantifiable concentration (AUC0-t) of HS-20152

Pharmacokinetic parameters of HS-20152 in plasma following a single dose

Time frame
Up to 24 weeks
4

Change from baseline in serum complement activity

Pharmacodynamic characteristics of HS-20152 following a single dose

Time frame
Up to 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: