Phase 1 Study of HS-20152 in Healthy Participants

NCT07503015 | Not Yet Recruiting Phase 1

• 1 other identifier: HS-20152-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

HS-20152; Phase 1; Healthy volunteers

Outcome Measures

Primary Outcomes (1)

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

  Up to 24 weeks

Secondary Outcomes (5)

• Maximum observed plasma concentration (Cmax) of HS-20152

  Up to 24 weeks

• Time to maximum concentration (Tmax) of HS-20152

  Up to 24 weeks

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

  Up to 24 weeks

• Change from baseline in serum complement activity

  Up to 24 weeks

• Proportion of participants with anti-drug antibodies (ADA) to HS-20152

  Up to 24 weeks

Study Arms (2)

HS-20152

EXPERIMENTAL

No additional descriptive information

Drug: HS-20152

Placebo

PLACEBO COMPARATOR

No additional descriptive information

Drug: Placebo

Interventions

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)

HS-20152

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Participants should be able to complete vaccinations against Neisseria meningitidis (types A, C, Y, and W-135) and streptococcus pneumoniae at least 2 weeks prior to the first dose.
• The participants are able to communicate clearly with the investigator, understand and comply with the requirements of this study, have a comprehensive understanding of the study content, process and possible adverse reactions, and sign the ICF voluntarily.

You may not qualify if:

• 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.
• Presence of non-active, active, or latent tuberculosis infection at screening (indicated by chest X-ray or CT showing tuberculosis lesions, or positive T-SPOT.TB results).
• Positive pregnancy test at screening, or pregnant or breastfeeding at screening, or planning to become pregnant during the study.
• Use of any medications, including prescription drugs, over-the-counter (OTC) drugs, herbal medicines, or dietary supplements, within 2 weeks prior to screening, or within 5 half-lives after the last dose of such medications, whichever is longer.
• Receipt of any live attenuated vaccine within 30 days prior to dosing; receipt of any vaccine not specified in the protocol within 5 days prior to dosing; or planned receipt of any vaccine not specified in the protocol during the study.
• Participation in other drug or medical device intervention clinical trials within 1 month prior to screening, and receipt of investigational drugs or use of medical devices, or being within 5 half-lives of the last dose of other investigational drugs, whichever is longer; or adverse events (AEs) from other trials that have not resolved to CTCAE Grade 1 or normal at screening.
• Receipt of siRNA or antisense oligonucleotide therapy within 18 months prior to dosing.
• Blood donation or blood loss of ≥ 450 mL (excluding menstruation) within 3 months prior to screening, or planned blood donation during the study.
• Average smoking of \> 5 cigarettes per day within 3 months prior to screening.
• Known history of drug abuse or drug use within 6 months prior to screening, or test positive for drug abuse at screening.
• Known history of alcohol dependence (average consumption of ≥14 units per week, with each unit equivalent to 285 mL of beer, 125 mL of wine, or 25 mL of spirits) within 6 months prior to screening, or positive alcohol breath test at screening.
• Undergone ≥ Grade 2 surgery within 6 months prior to screening, or plan to have surgery or hospitalization during the study.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

Location

Central Study Contacts

Yu Cao, Doctor

CONTACT

8618661809090; caoyu1767@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 31, 2026
• Study Start: April 22, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

CN (1)