A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2061

NCT07241910 | Not Yet Recruiting Phase 1

• 1 other identifier: SYH2061-001
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized, double-blind, placebo-controlled, single-ascending dose study in healthy subjects to evaluate the safety, tolerability, PK, and PD of SYH2061.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Number of Subjects with Adverse Events as Assessed by CTCAE v5.0

  To assess the safety and tolerability of SYH2061 in healthy subjects

  Up to Day 337

Secondary Outcomes (11)

• Maximum observed plasma concentration (Cmax) of SYH2061

  Up to 72 hours post-dose

• Time to maximum observed plasma concentration (Tmax) of SYH2061

  Up to 72 hours post-dose

• Area under the concentration-curve from zero to the last quantifiable concentration (AUClast) of SYH2061

  Up to 72 hours post-dose

• Area under the concentration-time curve from zero to infinity (AUCinf) of SYH2061

  Up to 72 hours post-dose

• Terminal elimination half-life (t1/2) of SYH2061

  Up to 72 hours post-dose

Study Arms (2)

SYH2061 group

EXPERIMENTAL

Subjects in experimental group will receive a single subcutaneous injection of SYH2061 on Day 1.

Drug: SYH2061

Placebo group

PLACEBO COMPARATOR

Subjects in placebo group will receive a single subcutaneous injection of placebo on Day 1.

Drug: Placebo

Interventions

SYH2061 DRUG

subcutaneous injection

SYH2061 group

Placebo DRUG

subcutaneous injection

Placebo group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must be informed of the study before it begins, fully understand the study content, procedures, and potential adverse reactions, and voluntarily sign the written ICF;
• Healthy male or female subjects, aged 18 to 55 years (inclusive);
• Body mass index ranging from 19.0 to 28.0 kg/m2 (inclusive), with a body weight of ≥ 50 kg for males and ≥ 45 kg for females;
• The results of various examinations, such as physical examination, vital signs, ECG, chest X-ray, abdominal B-scan ultrasound, and laboratory tests at screening are normal or abnormal without clinical significance;
• Vaccinated against meningococcal ACYW135 vaccine and pneumococcal vaccine at least 14 days prior to the first dose, or have valid documentation of receiving the respective vaccinations within the past 3 years prior to dosing as evaluated by the investigator.;
• Subjects and their partners agree to use effective and reliable contraceptive methods from 14 days before signing the ICF until 6 months after drug administration; male subjects agree not to donate sperm and female subjects agree not to donate ova from signing the ICF until 6 months after study drug administration;
• Subjects are able to communicate well with the investigator and can complete the study in accordance with the protocol.

You may not qualify if:

• History and/or current presence of clinically significant medical conditions, including but not limited to circulatory system disorders, hematological or hematopoietic system disorders, respiratory disorders, endocrine disorders, urinary system disorders, digestive system disorders, neurological or psychiatric disorders, autoimmune diseases, malignant tumors, severe trauma, or any other disease that should be excluded or may interfere with the interpretation of the study results in the opinion of the investigator;
• History of splenectomy, or functional or anatomical asplenia;
• Known or suspected hereditary or acquired complement deficiency or impaired complement activity, or complement activity below the normal range at screening;
• History of meningococcal infection, or positive Neisseria meningitides test at screening;
• Subjects who are frequently exposed to Neisseria meningitides (e.g., research, industrial, or clinical laboratory personnel, military personnel during recruit training, daycare center staff, etc.), and those who have traveled to or plan to travel to endemic areas for meningococcal meningitis (e.g., India, sub-Saharan Africa, Saudi Arabia) within 6 months before dosing or during the course of the study;
• History of recurrent or chronic infections (e.g., recurrent upper respiratory tract infection, diarrhoea, etc.) or infections requiring systemic antibiotic therapy within 3 months before dosing;
• Presence or suspicion of active viral, bacterial, fungal, or parasitic infection including herpes, herpes zoster, or cold sores within 14 days before dosing;
• History or current presence of latent or active pulmonary tuberculosis, or positive T-SPOT test at screening;
• History of major surgery within 6 months prior to screening, or plan to undergo major surgery during the course of the study;
• Subjects with severe allergic diseases or allergic constitution (≥ 3 drug or food allergies), or a known history of allergy to the investigational drug components, oligonucleotide drugs, or vaccinations;
• Subjects who are allergic to β-lactam antibiotics (e.g., penicillin, cephalosporins) or ciprofloxacin, or have any contraindications, or unwilling to use antibiotic prophylaxis as specified in the protocol;
• Intolerance to subcutaneous injection, or presence of abdominal scars (from surgery, burns, etc.) that affect subcutaneous administration, and any skin abnormalities and/or tattoos that may affect the safety assessment of the injection site;
• Any of the following liver function test results: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), γ-glutamyl transferase (GGT), or alkaline phosphatase (ALP) above the upper limit of normal at screening;
• Estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73 m2 (calculated by the simplified MDRD formula) at screening;
• Prolonged QT/QTc interval at screening or baseline (QTcF \> 450 ms for males, \> 470 ms for females);

Sponsors & Collaborators

• CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.: lead

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

+86-0311-69085587; ctr-contact@cspc.cn

Wei Hu

CONTACT

13856086475; huwei@ahmu.edu.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): November 24, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11