A Clinical Study to Evaluate SM17 in Healthy Participants

NCT07466940 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: SM17-103
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I study in Chinese healthy adult volunteer participants. It aims to evaluate the safety, tolerability, PK profile and immunogenicity of a single dose of SM17 SC in healthy Chinese adult participants. It also aims to evaluate the bioavailability of SM17 SC compared to SM17 IV.

Conditions

Atopic Dermatitis; Asthma; Inflammatory Bowel Disease

Keywords

AD; IL-17RB; IL-25 receptor

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment emergent AEs

  To evaluate the safety and tolerability of SM17 in Chinese healthy volunteers administrated with single dose of SM17 or placebo intravenously. Treatment emergent AE was any unfavorable or unintended medical occurrence in each subject, including any abnormal changes in vital signs or lab testing with clinical significance judged by investigators, that happened during the period of receiving or after receiving the investigational product, categorized by type, severity, and causality with the study drug

  Day 0 to Day 85

Secondary Outcomes (8)

• Area under the plasma concentration versus time curve (AUC)

  Day1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 43, 57, 85(Cohort A1, Cohort A2, Cohort A3); Day1, 2, 3, 4, 6, 8, 15, 29, 43, 57, 85(Cohort B).

• Peak Plasma Concentration (Cmax)

  Day1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 43, 57, 85(Cohort A1, Cohort A2, Cohort A3); Day1, 2, 3, 4, 6, 8, 15, 29, 43, 57, 85(Cohort B).

• Time to peak (Tmax)

  Day1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 43, 57, 85(Cohort A1, Cohort A2, Cohort A3); Day1, 2, 3, 4, 6, 8, 15, 29, 43, 57, 85(Cohort B).

• Elimination half-life (T1/2)

  Day1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 43, 57, 85(Cohort A1, Cohort A2, Cohort A3); Day1, 2, 3, 4, 6, 8, 15, 29, 43, 57, 85(Cohort B).

• Elimination Rate Constant (Kel)

  Day1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 43, 57, 85(Cohort A1, Cohort A2, Cohort A3); Day1, 2, 3, 4, 6, 8, 15, 29, 43, 57, 85(Cohort B).

Study Arms (4)

SM17 SC Cohort 1

EXPERIMENTAL

single ascending dose cohort A1, participants will receive Dose 1 of SM17 or placebo subcutaneously with randomization ratio 3:1

Biological: SM17; Drug: SM17 placebo

SM17 SC Cohort22

EXPERIMENTAL

single ascending dose cohort A2, participants will receive Dose2 of SM17 or placebo subcutaneously with randomization ratio 3:1

Biological: SM17; Drug: SM17 placebo

SM17 IV Cohort

EXPERIMENTAL

This is an open-label, single dose cohort B, participants will receive Dose2 of SM17 intravenously in this cohort. The SM17 SC A2 cohort and SM17 IV cohort (Cohort B) will be enrolled in parallel, and participants will be randomized 8:6 to one of the two cohorts.

Biological: SM17

SM17 SC Cohort 3

EXPERIMENTAL

single ascending dose cohort A3, participants will receive 780mg of SM17 or placebo subcutaneously in this cohort with randomization ratio 3:1

Biological: SM17; Drug: SM17 placebo

Interventions

SM17 BIOLOGICAL

SM17 monoclonal antibody

SM17 IV Cohort; SM17 SC Cohort 1; SM17 SC Cohort 3; SM17 SC Cohort22

SM17 placebo DRUG

placebo to be compared with SM17, excipient solution of SM17 monoclonal antibody without protein

SM17 SC Cohort 1; SM17 SC Cohort 3; SM17 SC Cohort22

Eligibility Criteria

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

You may qualify if:

• Be willing to sign the ICF, and be able to complete clinical visits and study-related procedures.
• Aged 18-55 years (both inclusive) at the time of signing the ICF, regardless of sex.
• Body mass index (BMI) ≥ 18.5 and \< 28.0 kg/m2, and body weight ≥ 50 kg (for males) and ≥ 45 kg (for females) at screening.
• Normal or abnormal but clinically insignificant findings in medical history and inquiries, vital signs, physical examination, laboratory tests (hematology, clinical chemistry, urinalysis, and coagulation tests), immunoglobulins, 12-lead ECG, and non-contrast chest CT at screening.
• Fertile men and women of childbearing potential must consent to use one of the highly effective contraceptive methods specified in Appendix 1 of the protocol from signing the ICF to 6 months after dosing, and have no plan to donate sperm or egg cells during this period.

You may not qualify if:

• Frequent alcohol consumption within 6 months prior to the screening visit, defined as an average weekly intake of \> 14 units of alcohol (1 unit of alcohol ≈ 360 mL of beer, 45 mL of spirit with the alcohol content of 40%, or 150 mL of wine), inability to abstain from alcohol from the screening visit or within 48 h pre-dose until the end of study (EOS), or a positive breath alcohol test at baseline.
• Current or history of clinically significant diseases deemed by the investigator to be clinically significant or likely to interfere with the study, including but not limited to diseases related to the neurological, cardiovascular, respiratory, hematological, endocrine, genitourinary, gastrointestinal, musculoskeletal systems, etc.
• Planned major surgery during the study, major surgery within 4 weeks prior to dosing, or surgical history deemed clinically significant by the investigator.
• Smoking history (\> 5 cigarettes per day on average) within 3 months prior to the screening visit, or inability to abstain from any tobacco products during the study.
• PR interval \> 210 ms on 12-lead ECG or QT interval corrected for heart rate using Fridericia's formula (QTcF; see Appendix 3): QTcF ≥ 450 ms for males and QTcF ≥ 470 ms for females.
• Abnormal laboratory parameter values as follows: a) total bilirubin \> 1.5 × upper limit of normal (ULN); b) alanine aminotransferase or aspartate aminotransferase \> 1.5 × ULN; c) serum creatinine \> ULN; d) white blood cell count below the lower limit of normal (LLN); or other abnormalities deemed by the investigator to be clinically significant, rendering the participant ineligible for enrollment.
• Recent infections (including chronic or localized infections) within 7 days prior to the screening visit, or presence of recurrent infections that, as assessed by the investigator, may affect the interpretation of trial results.
• Received a vaccine within 1 month prior to dosing.
• History of any malignancy within 5 years prior to the screening visit.
• History of known primary or secondary immunodeficiency disorders.
• History of drug abuse prior to dosing, or positive urine drug abuse screening at baseline.
• Known allergic reactions to monoclonal antibody components or excipients, or a history of suspected hypersensitivity reactions to the study drug or any components thereof as judged by the investigator.
• Positive screen test for HIV-Ab, HBsAg, HCV-Ab, or TP-Ab at screening;
• Received any prescription drugs, over-the-counter (OTC) drugs, biological products, dietary supplements, or Chinese herbal medicines within 14 days prior to dosing or 5 half-lives (whichever is longer); participated in another clinical trial involving an investigational drug/device and received investigational treatment within 3 months prior to dosing or 5 half-lives (whichever is longer); or participated in 3 or more clinical trials of drugs/devices and received investigational treatment within the past year.
• Presence of tattoos, scars, or any other conditions at or near the injection site that, in the investigator's opinion, may interfere with injection site assessment.

Sponsors & Collaborators

• SinoMab BioScience Ltd: lead

Study Sites (1)

PKUCare Luzhong Hospital

Zibo, Shandong, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Asthma; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

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

Model Details: 3 single ascending doses of SM17 will be administrated subcutaneously to Chinese Healthy volunteers, with at least 7-day post-administration safety ,tolerability and PK data reviewed under blinded condition by safety review council (SRC) meeting before dose-escalation. Each cohort of SM17 dosing consist of 6 individuals who will receive SM17 (subcutaneous injection) and the other 2 individuals who will receive matching placebo (subcutaneous injection). Another open labelled cohort of SM17 will be administrated SM17 intravenously with same dose as the second elevating dose in the SC cohorts, for studying bioavailability purpose.

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 12, 2026
• Study Start: October 14, 2025
• Primary Completion: February 5, 2026
• Study Completion: March 6, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

CN (1)