A Phase I Clinical Study to Evaluate SM17 in Chinese Healthy Subjects and Patients With Moderate to Severe Atopic Dermatitis

NCT07103369 | Completed Phase 1 FDA Drug

• 2 other identifiers: SM17-102CTR20233129
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a phase 1, randomized, double-blind, placebo-controlled trial conducted in Chinese Healthy Volunteers and Patients with moderate-to-severe Atopic Dermatitis It aims to evaluate the safety, tolerability, pharmacokinetic characteristics and immunogenicity of single and multiple doses of SM17 injection in healthy subjects . It also aims to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic effect and immunogenicity as well as preliminary efficacy in AD patients.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment emergent AEs in each cohort(Ph1a)

  Safety and tolerability of SM17 in Chinese healthy volunteers administrated with 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.

  Day 0 to Day85 (SAD cohorts), Day 0 to Day 113 (MD cohort)

• Incidence of Treatment emergent AEs (TEAEs) in each treatment group(ph1b)

  Safety and tolerability of SM17 in Chinese AD patients administrated with 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. changes in vital signs and lab testing

  Week 0 to Week 16

Secondary Outcomes (15)

• Area under the plasma concentration versus time curve (AUC) in Chinese healthy volunteers

  12 weeks following SM17 dose （SAD） or last dose （MD）

• Immunogenicity

  Baseline to 12 weeks following SM17/placebo dose (SAD) or last dose(MD)

• Area under the plasma concentration versus time curve (AUC) in Chinese AD patients

  Week 0 (baseline) to Week 16

• Efficacy for treating AD - EASI50%

  Week12, Week 16

• Efficacy for treating AD-EASI75%

  Week12, Week 16

Other Outcomes (11)

• PD biomarkers- total IgE

  Week0, 4, 8, 10, 12, 16

• Peak Plasma Concentration (Cmax) in healthy volunteers and AD patients

  12 weeks following SM17 dose (SAD) or last dose( MD) for ph1a, 0~16 week for ph1b

• Time to peak (Tmax)

  12 weeks following SM17 dose (SAD) or last dose( MD) for ph1a, 0~16 week for ph1b

Study Arms (7)

SAD cohort 1

EXPERIMENTAL

single ascending dose cohort 1, participants(HVs) will receive 70mg of SM17 or placebo intravenously in this cohort with randomization ratio 6:2

Drug: SM17 for injection; Other: SM17 placebo for injection

SAD cohort 2

EXPERIMENTAL

single ascending dose cohort 2, participants(HVs) will receive 200mg of SM17 or placebo intravenously in this cohort with randomization ratio 6:2

Drug: SM17 for injection; Other: SM17 placebo for injection

SAD cohort 3

EXPERIMENTAL

single ascending dose cohort 3, participants(HVs) will receive 600mg of SM17 or placebo intravenously in this cohort with randomization ratio 6:2

Drug: SM17 for injection; Other: SM17 placebo for injection

MD cohort

EXPERIMENTAL

multiple doses cohort, participants(HVs) will receive consecutive doses of 600mg of SM17 or placebo intravenously, once every 2 weeks in this cohort with randomization ratio 6:2

Drug: SM17 for injection; Other: SM17 placebo for injection

SM17 lower dose group

EXPERIMENTAL

treatment group for participants (AD patients) to receive lower consecutive dose of SM17 （200mg）intravenously once every 2 weeks until end of treatment

Drug: SM17 for injection

SM17 higher dose group

EXPERIMENTAL

treatment group for participants (AD patients) to receive higher consecutive dose of SM17 （200mg）intravenously once every 2 weeks until end of treatment

Drug: SM17 for injection

placebo group

PLACEBO COMPARATOR

control group for participants (AD patients) to receive placebo doses intravenously once every 2 weeks until end of treatment

Other: SM17 placebo for injection

Interventions

SM17 for injection DRUG

SM17 monoclonal antibody for intravenous infusion use

MD cohort; SAD cohort 1; SAD cohort 2; SAD cohort 3; SM17 higher dose group; SM17 lower dose group

SM17 placebo for injection OTHER

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

MD cohort; SAD cohort 1; SAD cohort 2; SAD cohort 3; placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Volunteers：
• Male or Female，19\~55 years old
• BMI ≥18.5 and \<28.0 kg/m² at the screening visit, with body weight ≥50 kg for males and ≥45 kg for females
• Non-smokers or former smokers who have quit for at least 6 months, with a smoking history of \<10 pack-years for former smokers at the screening visit. No history of alcohol consumption or light alcohol consumption prior to the screening visit.
• No abnormalities or abnormalities of no clinical significance (NCS) in vital signs, physical examination, laboratory tests, or electrocardiogram (ECG) results during the screening period, QTcF \<450 msec for male and QTcF \<470 msec for female subjects.
• Use one medically approved contraceptive method during the trial and for 6 months after the trial ends (specific methods see Appendix 1); No plans to donate sperm/ova during the trial and for 6 months after the trial ends.
• informed consent.
• Eligible patients must have a history of inadequate response or intolerance to treatment with topical AD medications.
• Male or female, 18 \~70 years old
• Atopic dermatitis (Hanifin \& Rajka) at the screening visit with eczema symptoms reported over 1year
• Eczema Area and Severity Index (EASI) score ≥16 at the screening and baseline visits
• Investigator's Global Assessment (IGA) score ≥3 at the screening and baseline visits
• ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits
• Baseline pruritus numerical rating scale (NRS) weekly average score ≥4
• Documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s) or for whom topical treatments are medically inadvisable (e.g. intolerance, because of important side effects, or safety risks)

You may not qualify if:

• Healthy volunteers:
• Presence of psychiatric or legal incapacity, significant emotional problems at the screening visit, or anticipation of such issues during the study period.
• Regular alcohol consumption within 6 months prior to screening.
• History or evidence of any clinically significant medical condition, situation, or disease.
• Any laboratory parameter meeting the following criteria:
• Total bilirubin (TBIL) \>1.5 × upper limit of normal (ULN)
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2 × ULN
• Serum creatinine (Cr) \>1.5 × ULN
• History or current diagnosis of cardiovascular/cerebrovascular disease.
• Prior hospitalization for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection.
• Evidence of any active or suspected bacterial, viral, fungal, or parasitic infection within 4 weeks prior to screening. Subjects deemed at high risk for parasitic diseases are also excluded.
• Known diagnosis of Type I/II diabetes mellitus or prediabetes.
• Administration of live (attenuated) vaccines within 1 month prior to first dose.
• History of any malignancy within 5 years prior to screening (except successfully treated carcinoma in situ of the cervix or surgically excised non-melanoma skin cancer).
• Any known history of primary or secondary immunodeficiency disorders.

Sponsors & Collaborators

• SinoMab BioScience Ltd: lead

Study Sites (1)

The First Hospital of China Medical University

Shenyang, Liaoning, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Injections

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

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Xin-Hua Gao, MD

  The First Hospital of China Medical University，Shenyang，Liaoning

  PRINCIPAL INVESTIGATOR

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

Model Details: Part 1: 3 single ascending dose (SAD) cohorts and 1 multiple dose (MD) cohort will be conducted sequentially, starting from the lowest dose SAD cohort, initiation of the following cohort will be upon judgement of safety review council(SRC) at least 7 days after the dosing of last cohort. Part 2: 2 doses of SM17 groups and placebo group will be enrolled and studied in parallel

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 5, 2025
• Study Start: November 21, 2023
• Primary Completion: March 24, 2025
• Study Completion: March 31, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)